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Flaxseed in Treating Postmenopausal Women With Hot Flashes Who Have a History of Breast Cancer or Other Cancer or Who Do Not Wish to Take Estrogen Therapy

Primary Purpose

Breast Cancer, Hot Flashes, Menopausal Symptoms

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
flaxseed
placebo
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring menopausal symptoms, hot flashes, breast cancer, unspecified adult solid tumor, protocol specific

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

  • Bothersome hot flashes, defined by their occurrence ≥ 28 times per week and of sufficient severity to make the patient desire therapeutic intervention

    • Presence of hot flashes for ≥ 1 month

  • Meets 1 of the following criteria:

    • History of breast cancer or other cancer (currently without malignant disease)
    • No history of breast cancer and wishes to avoid estrogen due to a perceived increased risk of breast cancer
  • Hormone receptor status not specified
  • Postmenopausal as defined by 1 of the following*:

NOTE: *Women with ≥ 1 ovary but without a uterus should be deemed postmenopausal by either age > 55 OR a combination of estrogen within a postmenopausal range (per local lab) and follicle-stimulating hormone > 40 mIU/mL

  • Absence of a period in the past 12 months

  • Bilateral oophorectomy

    • ECOG performance status 0-1
    • Life expectancy ≥ 6 months
    • Able to complete questionnaire(s) alone or with assistance
    • No diabetes requiring oral or injectable antihyperglycemics
    • No hypotension
    • No history of allergic or other adverse reaction to flaxseed
    • No irritable bowel syndrome, colitis, Crohn disease, or any gastrointestinal condition where the patient should not consume and/or has an intolerance/allergies to seeds or nuts
    • At least 4 weeks since prior and no concurrent or planned androgens, estrogens, or progestational agents

  • Tamoxifen, raloxifene, or aromatase inhibitors are allowed provided the patient has been on a constant dose for ≥ 4 weeks and is not expected to stop the medication during study treatment

    • At least 4 weeks since prior and no concurrent anti-cancer therapies of any kind

  • Trastuzumab allowed

    • No concurrent treatment with other anti-cancer therapies of any kind except for trastuzumab or endocrine therapies
    • No concurrent (≤ 7 days prior to registration) or planned use of other agents for treating hot flashes (i.e., gabapentin, clonidine, antidepressants, estrogen treatment, megestrol acetate, or Bellergal)
  • Stable dose of vitamin E (as a general vitamin supplement) allowed provided it is ≤ 800 IU/day, it was started > 30 days before study initiation, and is to be continued through study period

  • Patients who have been using antidepressants for mood and have been on a stable dose for over a month and meet the eligibility criteria for hot flash frequency and duration are eligible

    • No concurrent anticoagulants or anti-platelets (1 mg of Coumadin for central line patency allowed)

  • Aspirin allowed (≤ 81 mg)

    • No concurrent anti-hypertensives
    • No other concurrent herbal supplements for any reason, including soy and soy supplements (i.e., powders, pills, or milk)

Sites / Locations

  • Aurora Presbyterian Hospital
  • Boulder Community Hospital
  • Penrose Cancer Center at Penrose Hospital
  • St. Anthony Central Hospital
  • Porter Adventist Hospital
  • Presbyterian - St. Luke's Medical Center
  • St. Joseph Hospital
  • Rose Medical Center
  • CCOP - Colorado Cancer Research Program
  • Swedish Medical Center
  • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
  • North Colorado Medical Center
  • Sky Ridge Medical Center
  • Hope Cancer Care Center at Longmont United Hospital
  • McKee Medical Center
  • St. Mary - Corwin Regional Medical Center
  • North Suburban Medical Center
  • Exempla Lutheran Medical Center
  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
  • Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
  • St. Francis Hospital and Health Centers - Beech Grove Campus
  • Elkhart Clinic, LLC
  • Elkhart General Hospital
  • Howard Community Hospital
  • Center for Cancer Therapy at LaPorte Hospital and Health Services
  • Saint Joseph Regional Medical Center
  • Reid Hospital & Health Care Services
  • CCOP - Northern Indiana CR Consortium
  • Memorial Hospital of South Bend
  • Michiana Hematology-Oncology, PC - South Bend
  • South Bend Clinic
  • Medical Oncology and Hematology Associates - West Des Moines
  • CCOP - Iowa Oncology Research Association
  • John Stoddard Cancer Center at Iowa Methodist Medical Center
  • Medical Oncology and Hematology Associates at John Stoddard Cancer Center
  • Medical Oncology and Hematology Associates at Mercy Cancer Center
  • Mercy Cancer Center at Mercy Medical Center - Des Moines
  • John Stoddard Cancer Center at Iowa Lutheran Hospital
  • McCreery Cancer Center at Ottumwa Regional
  • Siouxland Hematology-Oncology Associates, LLP
  • Mercy Medical Center - Sioux City
  • St. Luke's Regional Medical Center
  • Drs. Carrol, Sheth, Raghavan
  • Saint Joseph Mercy Cancer Center
  • CCOP - Michigan Cancer Research Consortium
  • Battle Creek Health System Cancer Care Center
  • Mecosta County Medical Center
  • Oakwood Cancer Center at Oakwood Hospital and Medical Center
  • Green Bay Oncology, Limited - Escanaba
  • Genesys Hurley Cancer Institute
  • Hurley Medical Center
  • Butterworth Hospital at Spectrum Health
  • CCOP - Grand Rapids
  • Lacks Cancer Center at Saint Mary's Health Care
  • Van Elslander Cancer Center at St. John Hospital and Medical Center
  • Dickinson County Healthcare System
  • Foote Memorial Hospital
  • Sparrow Regional Cancer Center
  • St. Mary Mercy Hospital
  • Mercy General Health Partners
  • St. Joseph Mercy Oakland
  • Mercy Regional Cancer Center at Mercy Hospital
  • Seton Cancer Institute at Saint Mary's - Saginaw
  • Lakeside Cancer Specialists, PLLC
  • Lakeland Regional Cancer Care Center - St. Joseph
  • Munson Medical Center
  • St. John Macomb Hospital
  • Metro Health Hospital
  • MeritCare Bemidji
  • Fergus Falls Medical Group, PA
  • Immanuel St. Joseph's
  • CCOP - MeritCare Hospital
  • MeritCare Broadway
  • Altru Cancer Center at Altru Hospital
  • Grandview Hospital
  • Good Samaritan Hospital
  • David L. Rike Cancer Center at Miami Valley Hospital
  • CCOP - Dayton
  • Blanchard Valley Medical Associates
  • Middletown Regional Hospital
  • Wayne Hospital
  • Charles F. Kettering Memorial Hospital
  • UVMC Cancer Care Center at Upper Valley Medical Center
  • Clinton Memorial Hospital
  • United States Air Force Medical Center - Wright-Patterson
  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
  • Providence Milwaukie Hospital
  • Providence Cancer Center at Providence Portland Medical Center
  • Adventist Medical Center
  • CCOP - Columbia River Oncology Program
  • Providence St. Vincent Medical Center
  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
  • Rapid City Regional Hospital
  • Medical X-Ray Center, PC
  • Sanford Cancer Center at Sanford USD Medical Center
  • Southwest Washington Medical Center Cancer Center
  • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
  • Green Bay Oncology, Limited at St. Mary's Hospital
  • St. Mary's Hospital Medical Center - Green Bay
  • St. Vincent Hospital Regional Cancer Center
  • Holy Family Memorial Medical Center Cancer Care Center
  • Bay Area Cancer Care Center at Bay Area Medical Center
  • Green Bay Oncology, Limited - Oconto Falls
  • Green Bay Oncology, Limited - Sturgeon Bay
  • Marshfield Clinic - Wisconsin Rapids Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm I

Arm II

Arm Description

Patients receive oral flaxseed in the form of a bar similar to a granola bar once daily.

Patients receive oral placebo bar once daily.

Outcomes

Primary Outcome Measures

To Evaluate the Efficacy of Flaxseed on Hot Flash Scores in Women as Measured by a Daily Prospective Hot Flash Diary.
The intra-patient difference in hot flash activity between baseline (study week 1) and treatment termination (study week 7) is the primary endpoint. The hot flash activity will be measured by the weekly average hot flash score which is a composite entity of both frequency and severity of hot flashes. The hot flash severities are graded from 1 to 4, ranging from mild, to moderate, to severe to very severe. The daily hot flash score is computed by multiplying the mean grade of severity by the frequency during every 24 hour period. Therefore, a score of zero is the lowest possible score and can be interpreted as having no hot flashes. The average daily hot flash score during the baseline week was compared to the average daily value during week 7. The primary method of analysis will be the independent sample t-test to examine the change of weekly average hot flash score from baseline to treatment termination between flaxseed and placebo arms.

Secondary Outcome Measures

Toxicity as Measured by CTCAE v3.0
Frequency and severity of adverse events were reported by patients weekly evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report.
Change of Mood as Measured by the Profile of Mood States (POMS)
Profile of Mood States (POMS) was used to look at total mood disturbance as well as the subscales of tension-anxiety, fatigue-inertia, and vigor-activity. The POMS is a well known, well validated, reliable measure of psychological distress which includes 6 subscales of fatigue-inertia, vigor-activity, tension-anxiety, depression-dejection, anger-hostility, and confusion-bewilderment. The entire scale can be scored to provide a measure of total mood disturbance. The measure contains adjectives related to mood which are scored from 0 (not at all) to 4 (extremely). Individual scores were converted to a 0-100 scale where 100 is best quality of life. The change of mood as measured by the POMS from baseline to treatment termination between flaxseed versus placebo arms was compared using Kruskal-Wallis test. The mean change in total score for each arm is reported.
Change of Menopause Specific Quality of Life as Measured by the Menopause Specific Quality of Life (MENQOL)
The change in quality of life as measured by the MENQOL from baseline to treatment termination between flaxseed versus placebo arms was evaluated. On a 0-6 scale, patients were asked to answer questions in in each of 4 domain scores (Vasomotor, Psychosocial, Physical, Sexual) Scores were converted to a 0-100 scale where 100 is best QOL. The change in score from baseline to end of treatment were analyzed separately for each domain. Here we report the mean change in score for each category.
Change of Daily Interference as Measured by the Hot Flash Related Daily Interference Scale (HFRDIS)
The change of daily interference as measured by the HFRDIS from baseline to treatment termination between flaxseed versus placebo arms was evaluated with an independent t-test for continuous data. On a 0-10 scale, patients were asked to describe how hot flashes interfered with 10 different aspects of their life (work, social activities, leisure activities, sleep, mood, concentration, relationships with others, sexuality, enjoyment of life and overall quality of life). Scores were converted to a 0-100 scale where 100 is best QOL.The HFRDIS total score was the average of the 10 individual questions. The change in total score from baseline to end of treatment was analyzed between the groups using a Kruskal-Wallace test.

Full Information

First Posted
August 8, 2009
Last Updated
February 16, 2017
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00956813
Brief Title
Flaxseed in Treating Postmenopausal Women With Hot Flashes Who Have a History of Breast Cancer or Other Cancer or Who Do Not Wish to Take Estrogen Therapy
Official Title
Phase III, Randomized, Placebo-controlled, Double-Blind Trial of Flaxseed for the Treatment of Hot Flashes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Estrogen can relieve the symptoms of menopause, but can also cause the growth of breast cancer cells. Flaxseed may reduce the number of hot flashes and improve mood and quality of life in postmenopausal women not receiving estrogen therapy. PURPOSE: This randomized phase III trial is studying flaxseed to see how well it works in treating postmenopausal women with hot flashes who have a history of breast cancer or other cancer or who do not wish to take estrogen therapy.
Detailed Description
OBJECTIVES: To evaluate the efficacy of flaxseed on hot flash scores in women with a history of breast cancer or other cancer or in women who do not wish to take estrogen therapy for fear of increased risk of breast cancer as measured by a daily prospective hot flash diary. To evaluate the side effect profile of flaxseed in this population. To evaluate the effects of flaxseed on mood (per the Profile of Mood States) and broader menopausal symptoms (per the MENQOL), daily interference from hot flashes (per the HFRDIS), and perception of benefit (per Global Impression of Change). OUTLINE: Patients are stratified according to age (18-49 years vs ≥ 50 years); treatment with tamoxifen citrate, selective estrogen receptor modulators, or aromatase inhibitors (yes vs no); duration of hot flashes (≤ 9 months vs > 9 months); and daily frequency of hot flashes (4-9 vs ≥ 10). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral flaxseed in the form of a bar similar to a granola bar once daily. Arm II: Patients receive oral placebo bar once daily. In both arms, treatment continues for 6-12 weeks. Patients in arm II may crossover to receive treatment as in arm I after 6 weeks. Patients complete questionnaires (Hot Flash Diary, Side Effect Experience Questionnaire, Profile of Mood States, Hot Flash Related Daily Interference Scale, and Menopause Specific Quality of Life) at baseline and periodically during treatment. Patients are contacted by telephone at the end of weeks 2, 4, 5, and 7 to assess product tolerability, document compliance, encourage completion of questionnaires, and address problems.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Hot Flashes, Menopausal Symptoms, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
menopausal symptoms, hot flashes, breast cancer, unspecified adult solid tumor, protocol specific

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive oral flaxseed in the form of a bar similar to a granola bar once daily.
Arm Title
Arm II
Arm Type
Placebo Comparator
Arm Description
Patients receive oral placebo bar once daily.
Intervention Type
Dietary Supplement
Intervention Name(s)
flaxseed
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Given orally
Primary Outcome Measure Information:
Title
To Evaluate the Efficacy of Flaxseed on Hot Flash Scores in Women as Measured by a Daily Prospective Hot Flash Diary.
Description
The intra-patient difference in hot flash activity between baseline (study week 1) and treatment termination (study week 7) is the primary endpoint. The hot flash activity will be measured by the weekly average hot flash score which is a composite entity of both frequency and severity of hot flashes. The hot flash severities are graded from 1 to 4, ranging from mild, to moderate, to severe to very severe. The daily hot flash score is computed by multiplying the mean grade of severity by the frequency during every 24 hour period. Therefore, a score of zero is the lowest possible score and can be interpreted as having no hot flashes. The average daily hot flash score during the baseline week was compared to the average daily value during week 7. The primary method of analysis will be the independent sample t-test to examine the change of weekly average hot flash score from baseline to treatment termination between flaxseed and placebo arms.
Time Frame
Baseline and 7 weeks
Secondary Outcome Measure Information:
Title
Toxicity as Measured by CTCAE v3.0
Description
Frequency and severity of adverse events were reported by patients weekly evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report.
Time Frame
Up to 7 weeks
Title
Change of Mood as Measured by the Profile of Mood States (POMS)
Description
Profile of Mood States (POMS) was used to look at total mood disturbance as well as the subscales of tension-anxiety, fatigue-inertia, and vigor-activity. The POMS is a well known, well validated, reliable measure of psychological distress which includes 6 subscales of fatigue-inertia, vigor-activity, tension-anxiety, depression-dejection, anger-hostility, and confusion-bewilderment. The entire scale can be scored to provide a measure of total mood disturbance. The measure contains adjectives related to mood which are scored from 0 (not at all) to 4 (extremely). Individual scores were converted to a 0-100 scale where 100 is best quality of life. The change of mood as measured by the POMS from baseline to treatment termination between flaxseed versus placebo arms was compared using Kruskal-Wallis test. The mean change in total score for each arm is reported.
Time Frame
Baseline and up to 7 weeks
Title
Change of Menopause Specific Quality of Life as Measured by the Menopause Specific Quality of Life (MENQOL)
Description
The change in quality of life as measured by the MENQOL from baseline to treatment termination between flaxseed versus placebo arms was evaluated. On a 0-6 scale, patients were asked to answer questions in in each of 4 domain scores (Vasomotor, Psychosocial, Physical, Sexual) Scores were converted to a 0-100 scale where 100 is best QOL. The change in score from baseline to end of treatment were analyzed separately for each domain. Here we report the mean change in score for each category.
Time Frame
Baseline and up to 7 weeks
Title
Change of Daily Interference as Measured by the Hot Flash Related Daily Interference Scale (HFRDIS)
Description
The change of daily interference as measured by the HFRDIS from baseline to treatment termination between flaxseed versus placebo arms was evaluated with an independent t-test for continuous data. On a 0-10 scale, patients were asked to describe how hot flashes interfered with 10 different aspects of their life (work, social activities, leisure activities, sleep, mood, concentration, relationships with others, sexuality, enjoyment of life and overall quality of life). Scores were converted to a 0-100 scale where 100 is best QOL.The HFRDIS total score was the average of the 10 individual questions. The change in total score from baseline to end of treatment was analyzed between the groups using a Kruskal-Wallace test.
Time Frame
Baseline and up to 7 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Bothersome hot flashes, defined by their occurrence ≥ 28 times per week and of sufficient severity to make the patient desire therapeutic intervention Presence of hot flashes for ≥ 1 month Meets 1 of the following criteria: History of breast cancer or other cancer (currently without malignant disease) No history of breast cancer and wishes to avoid estrogen due to a perceived increased risk of breast cancer Hormone receptor status not specified Postmenopausal as defined by 1 of the following*: NOTE: *Women with ≥ 1 ovary but without a uterus should be deemed postmenopausal by either age > 55 OR a combination of estrogen within a postmenopausal range (per local lab) and follicle-stimulating hormone > 40 mIU/mL Absence of a period in the past 12 months Bilateral oophorectomy ECOG performance status 0-1 Life expectancy ≥ 6 months Able to complete questionnaire(s) alone or with assistance No diabetes requiring oral or injectable antihyperglycemics No hypotension No history of allergic or other adverse reaction to flaxseed No irritable bowel syndrome, colitis, Crohn disease, or any gastrointestinal condition where the patient should not consume and/or has an intolerance/allergies to seeds or nuts At least 4 weeks since prior and no concurrent or planned androgens, estrogens, or progestational agents Tamoxifen, raloxifene, or aromatase inhibitors are allowed provided the patient has been on a constant dose for ≥ 4 weeks and is not expected to stop the medication during study treatment • At least 4 weeks since prior and no concurrent anti-cancer therapies of any kind Trastuzumab allowed No concurrent treatment with other anti-cancer therapies of any kind except for trastuzumab or endocrine therapies No concurrent (≤ 7 days prior to registration) or planned use of other agents for treating hot flashes (i.e., gabapentin, clonidine, antidepressants, estrogen treatment, megestrol acetate, or Bellergal) Stable dose of vitamin E (as a general vitamin supplement) allowed provided it is ≤ 800 IU/day, it was started > 30 days before study initiation, and is to be continued through study period Patients who have been using antidepressants for mood and have been on a stable dose for over a month and meet the eligibility criteria for hot flash frequency and duration are eligible • No concurrent anticoagulants or anti-platelets (1 mg of Coumadin for central line patency allowed) Aspirin allowed (≤ 81 mg) No concurrent anti-hypertensives No other concurrent herbal supplements for any reason, including soy and soy supplements (i.e., powders, pills, or milk)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debra Barton, RN, PhD, AOCN, FAAN
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Aurora Presbyterian Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Boulder Community Hospital
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301-9019
Country
United States
Facility Name
Penrose Cancer Center at Penrose Hospital
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80933
Country
United States
Facility Name
St. Anthony Central Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Porter Adventist Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Presbyterian - St. Luke's Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
St. Joseph Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Rose Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
CCOP - Colorado Cancer Research Program
City
Denver
State/Province
Colorado
ZIP/Postal Code
80224-2522
Country
United States
Facility Name
Swedish Medical Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80110
Country
United States
Facility Name
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81502
Country
United States
Facility Name
North Colorado Medical Center
City
Greeley
State/Province
Colorado
ZIP/Postal Code
80631
Country
United States
Facility Name
Sky Ridge Medical Center
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Hope Cancer Care Center at Longmont United Hospital
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
McKee Medical Center
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80539
Country
United States
Facility Name
St. Mary - Corwin Regional Medical Center
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81004
Country
United States
Facility Name
North Suburban Medical Center
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80229
Country
United States
Facility Name
Exempla Lutheran Medical Center
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Facility Name
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
City
Moline
State/Province
Illinois
ZIP/Postal Code
61265
Country
United States
City
Moline
State/Province
Illinois
ZIP/Postal Code
61265
Country
United States
Facility Name
St. Francis Hospital and Health Centers - Beech Grove Campus
City
Beech Grove
State/Province
Indiana
ZIP/Postal Code
46107
Country
United States
Facility Name
Elkhart Clinic, LLC
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46514-2098
Country
United States
Facility Name
Elkhart General Hospital
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46515
Country
United States
Facility Name
Howard Community Hospital
City
Kokomo
State/Province
Indiana
ZIP/Postal Code
46904
Country
United States
Facility Name
Center for Cancer Therapy at LaPorte Hospital and Health Services
City
La Porte
State/Province
Indiana
ZIP/Postal Code
46350
Country
United States
Facility Name
Saint Joseph Regional Medical Center
City
Mishawaka
State/Province
Indiana
ZIP/Postal Code
46545-1470
Country
United States
Facility Name
Reid Hospital & Health Care Services
City
Richmond
State/Province
Indiana
ZIP/Postal Code
47374
Country
United States
Facility Name
CCOP - Northern Indiana CR Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Memorial Hospital of South Bend
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Michiana Hematology-Oncology, PC - South Bend
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
South Bend Clinic
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
City
Bettendorf
State/Province
Iowa
ZIP/Postal Code
52722
Country
United States
Facility Name
Medical Oncology and Hematology Associates - West Des Moines
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
CCOP - Iowa Oncology Research Association
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
John Stoddard Cancer Center at Iowa Methodist Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Medical Oncology and Hematology Associates at Mercy Cancer Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Mercy Cancer Center at Mercy Medical Center - Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
John Stoddard Cancer Center at Iowa Lutheran Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50316
Country
United States
Facility Name
McCreery Cancer Center at Ottumwa Regional
City
Ottumwa
State/Province
Iowa
ZIP/Postal Code
52501
Country
United States
Facility Name
Siouxland Hematology-Oncology Associates, LLP
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Mercy Medical Center - Sioux City
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
St. Luke's Regional Medical Center
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
Drs. Carrol, Sheth, Raghavan
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40215
Country
United States
Facility Name
Saint Joseph Mercy Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106-0995
Country
United States
Facility Name
CCOP - Michigan Cancer Research Consortium
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Battle Creek Health System Cancer Care Center
City
Battle Creek
State/Province
Michigan
ZIP/Postal Code
49017
Country
United States
Facility Name
Mecosta County Medical Center
City
Big Rapids
State/Province
Michigan
ZIP/Postal Code
49307
Country
United States
Facility Name
Oakwood Cancer Center at Oakwood Hospital and Medical Center
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48123-2500
Country
United States
Facility Name
Green Bay Oncology, Limited - Escanaba
City
Escanaba
State/Province
Michigan
ZIP/Postal Code
49431
Country
United States
Facility Name
Genesys Hurley Cancer Institute
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Butterworth Hospital at Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
CCOP - Grand Rapids
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Lacks Cancer Center at Saint Mary's Health Care
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Van Elslander Cancer Center at St. John Hospital and Medical Center
City
Grosse Pointe Woods
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Dickinson County Healthcare System
City
Iron Mountain
State/Province
Michigan
ZIP/Postal Code
49801
Country
United States
Facility Name
Foote Memorial Hospital
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49201
Country
United States
Facility Name
Sparrow Regional Cancer Center
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912-1811
Country
United States
Facility Name
St. Mary Mercy Hospital
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48154
Country
United States
Facility Name
Mercy General Health Partners
City
Muskegon
State/Province
Michigan
ZIP/Postal Code
49443
Country
United States
Facility Name
St. Joseph Mercy Oakland
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341-2985
Country
United States
Facility Name
Mercy Regional Cancer Center at Mercy Hospital
City
Port Huron
State/Province
Michigan
ZIP/Postal Code
48060
Country
United States
Facility Name
Seton Cancer Institute at Saint Mary's - Saginaw
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
Lakeside Cancer Specialists, PLLC
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Lakeland Regional Cancer Care Center - St. Joseph
City
St. Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Munson Medical Center
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
St. John Macomb Hospital
City
Warren
State/Province
Michigan
ZIP/Postal Code
48093
Country
United States
Facility Name
Metro Health Hospital
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
MeritCare Bemidji
City
Bemidji
State/Province
Minnesota
ZIP/Postal Code
56601
Country
United States
Facility Name
Fergus Falls Medical Group, PA
City
Fergus Falls
State/Province
Minnesota
ZIP/Postal Code
56537
Country
United States
Facility Name
Immanuel St. Joseph's
City
Mankato
State/Province
Minnesota
ZIP/Postal Code
56002
Country
United States
Facility Name
CCOP - MeritCare Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
MeritCare Broadway
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Altru Cancer Center at Altru Hospital
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58201
Country
United States
Facility Name
Grandview Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45405
Country
United States
Facility Name
Good Samaritan Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
David L. Rike Cancer Center at Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
CCOP - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45420
Country
United States
Facility Name
Blanchard Valley Medical Associates
City
Findlay
State/Province
Ohio
ZIP/Postal Code
45840
Country
United States
Facility Name
Middletown Regional Hospital
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005-1066
Country
United States
Facility Name
Wayne Hospital
City
Greenville
State/Province
Ohio
ZIP/Postal Code
45331
Country
United States
Facility Name
Charles F. Kettering Memorial Hospital
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
UVMC Cancer Care Center at Upper Valley Medical Center
City
Troy
State/Province
Ohio
ZIP/Postal Code
45373-1300
Country
United States
Facility Name
Clinton Memorial Hospital
City
Wilmington
State/Province
Ohio
ZIP/Postal Code
45177
Country
United States
Facility Name
United States Air Force Medical Center - Wright-Patterson
City
Wright-Patterson Afb
State/Province
Ohio
ZIP/Postal Code
45433-5529
Country
United States
Facility Name
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
City
Xenia
State/Province
Ohio
ZIP/Postal Code
45385
Country
United States
Facility Name
Providence Milwaukie Hospital
City
Milwaukie
State/Province
Oregon
ZIP/Postal Code
97222
Country
United States
Facility Name
Providence Cancer Center at Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213-2967
Country
United States
Facility Name
Adventist Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97216
Country
United States
Facility Name
CCOP - Columbia River Oncology Program
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Providence St. Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18105
Country
United States
Facility Name
Rapid City Regional Hospital
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Medical X-Ray Center, PC
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Sanford Cancer Center at Sanford USD Medical Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5039
Country
United States
Facility Name
Southwest Washington Medical Center Cancer Center
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98668
Country
United States
Facility Name
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301-3526
Country
United States
Facility Name
Green Bay Oncology, Limited at St. Mary's Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
Facility Name
St. Mary's Hospital Medical Center - Green Bay
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
Facility Name
St. Vincent Hospital Regional Cancer Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54307-3508
Country
United States
Facility Name
Holy Family Memorial Medical Center Cancer Care Center
City
Manitowoc
State/Province
Wisconsin
ZIP/Postal Code
54221-1450
Country
United States
Facility Name
Bay Area Cancer Care Center at Bay Area Medical Center
City
Marinette
State/Province
Wisconsin
ZIP/Postal Code
54143
Country
United States
Facility Name
Green Bay Oncology, Limited - Oconto Falls
City
Oconto Falls
State/Province
Wisconsin
ZIP/Postal Code
54154
Country
United States
Facility Name
Green Bay Oncology, Limited - Sturgeon Bay
City
Sturgeon Bay
State/Province
Wisconsin
ZIP/Postal Code
54235
Country
United States
Facility Name
Marshfield Clinic - Wisconsin Rapids Center
City
Wisconsin Rapids
State/Province
Wisconsin
ZIP/Postal Code
54494
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21900849
Citation
Pruthi S, Qin R, Terstreip SA, Liu H, Loprinzi CL, Shah TR, Tucker KF, Dakhil SR, Bury MJ, Carolla RL, Steen PD, Vuky J, Barton DL. A phase III, randomized, placebo-controlled, double-blind trial of flaxseed for the treatment of hot flashes: North Central Cancer Treatment Group N08C7. Menopause. 2012 Jan;19(1):48-53. doi: 10.1097/gme.0b013e318223b021.
Results Reference
result
Citation
Pruthi S, Qin R, Terstriep SA, et al.: The evaluation of flaxseed for hot flashes: results of a randomized, controlled trial, NCCTG study N08C7. [Abstract] J Clin Oncol 29 (Suppl 15): A-CRA9015, 2011.
Results Reference
result

Learn more about this trial

Flaxseed in Treating Postmenopausal Women With Hot Flashes Who Have a History of Breast Cancer or Other Cancer or Who Do Not Wish to Take Estrogen Therapy

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