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Omega-3 Fatty Acid in Reducing Cancer-Related Fatigue in Breast Cancer Survivors

Primary Purpose

Breast Carcinoma, Cancer, Fatigue

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Omega-3 Fatty Acid
Placebo
Questionnaire Administration
Laboratory Biomarker Analysis
Sponsored by
Gary Morrow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Carcinoma focused on measuring Cancer Survivor

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Have a confirmed diagnosis of breast cancer; participants can have had more than one primary cancer diagnosis in the past
  • Have undergone some type or combination of standard adjuvant treatment (surgery, chemotherapy, radiation therapy) for breast cancer
  • Have completed all forms of standard adjuvant treatment (surgery, chemotherapy, radiation therapy) for breast cancer between 4 and 36 months prior to enrollment in the study; participants can be currently taking hormones (such as tamoxifen) or monoclonal antibodies (such as Herceptin)
  • Must have cancer-related fatigue, as indicated by a response of 4 or greater when asked to rate their level of fatigue at its worst in the past week on an 11-point scale anchored by "0" = no fatigue and "10" = as bad as you can imagine
  • Be able to read English
  • Able to swallow medication
  • Give written informed consent

Exclusion Criteria:

  • Have used marine omega-3 supplements at any time within previous 3 months (this includes prescription omega-3 drugs such as Lovaza®)
  • Be taking anticoagulant medication (does not include aspirin)
  • Have sensitivity or allergy to fish and/or shellfish
  • Have sensitivity or allergy to soy and/or soybeans
  • Have confirmed diagnosis of chronic fatigue syndrome or other diagnosis known to cause severe fatigue

Sites / Locations

  • Wichita NCORP
  • Cancer Research Consortium of West Michigan
  • University of Rochester NCORP Research Base
  • Dayton NCORP
  • Greenville Health System NCORP
  • Wisconsin NCORP

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Arm I (low-dose omega-3 fatty acid)

Arm II (high-dose omega-3 fatty acid)

Arm III (placebo)

Arm Description

Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.

Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.

Patients receive placebo PO BID for 6 weeks.

Outcomes

Primary Outcome Measures

Mean Change (6 Weeks - Baseline) and Standard Deviation in Cancer-related Fatigue, Using the Brief Fatigue Inventory-Short Form (BFI-SF) and Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF). 81 Subjects Had Both a Baseline and 6 Week Value
BFI-SF is a 4 item questionnaire to assess the severity of fatigue, ranging from 0 (No Fatigue) to 10 (As bad as you can imagine). MFSI-SF is a 30 item questionnaire to assess the level of fatigue in terms of general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor). First four subscales (general, physical, emotional, and mental) are summed and the vigor scale is subtracted to create fatigue total score with a range of -32 (low fatigue) to 96 (high fatigue).

Secondary Outcome Measures

Full Information

First Posted
January 28, 2015
Last Updated
July 5, 2017
Sponsor
Gary Morrow
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02352779
Brief Title
Omega-3 Fatty Acid in Reducing Cancer-Related Fatigue in Breast Cancer Survivors
Official Title
Feasibility of Omega-3 Supplementation for Cancer-Related Fatigue
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gary Morrow
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This randomized pilot clinical trial studies omega-3 fatty acid in reducing cancer-related fatigue in breast cancer survivors. Supplementation with omega-3 fatty acid may help reduce cancer-related fatigue in breast cancer survivors.
Detailed Description
PRIMARY OBJECTIVE: I. To collect preliminary statistical data (mean changes and standard deviations) on two omega-3 supplementation (omega-3 fatty acid) regimens (1.65 g/day and 3.3 g/day) compared to placebo for reducing cancer-related fatigue (CRF) in fatigued breast cancer survivors. OUTLINE: Patients are randomized to 1 of 3 arms. ARM I: Patients receive low-dose omega-3 fatty acid supplementation orally (PO) twice daily (BID) and placebo PO BID for 6 weeks. ARM II: Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks. ARM III: Patients receive placebo PO BID for 6 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma, Cancer, Fatigue
Keywords
Cancer Survivor

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (low-dose omega-3 fatty acid)
Arm Type
Experimental
Arm Description
Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.
Arm Title
Arm II (high-dose omega-3 fatty acid)
Arm Type
Experimental
Arm Description
Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.
Arm Title
Arm III (placebo)
Arm Type
Placebo Comparator
Arm Description
Patients receive placebo PO BID for 6 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 Fatty Acid
Other Intervention Name(s)
O3FA, Omega-3 Fatty Acids, Omega-3 PUFA
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
PLCB
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Mean Change (6 Weeks - Baseline) and Standard Deviation in Cancer-related Fatigue, Using the Brief Fatigue Inventory-Short Form (BFI-SF) and Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF). 81 Subjects Had Both a Baseline and 6 Week Value
Description
BFI-SF is a 4 item questionnaire to assess the severity of fatigue, ranging from 0 (No Fatigue) to 10 (As bad as you can imagine). MFSI-SF is a 30 item questionnaire to assess the level of fatigue in terms of general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor). First four subscales (general, physical, emotional, and mental) are summed and the vigor scale is subtracted to create fatigue total score with a range of -32 (low fatigue) to 96 (high fatigue).
Time Frame
Baseline to 6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have a confirmed diagnosis of breast cancer; participants can have had more than one primary cancer diagnosis in the past Have undergone some type or combination of standard adjuvant treatment (surgery, chemotherapy, radiation therapy) for breast cancer Have completed all forms of standard adjuvant treatment (surgery, chemotherapy, radiation therapy) for breast cancer between 4 and 36 months prior to enrollment in the study; participants can be currently taking hormones (such as tamoxifen) or monoclonal antibodies (such as Herceptin) Must have cancer-related fatigue, as indicated by a response of 4 or greater when asked to rate their level of fatigue at its worst in the past week on an 11-point scale anchored by "0" = no fatigue and "10" = as bad as you can imagine Be able to read English Able to swallow medication Give written informed consent Exclusion Criteria: Have used marine omega-3 supplements at any time within previous 3 months (this includes prescription omega-3 drugs such as Lovaza®) Be taking anticoagulant medication (does not include aspirin) Have sensitivity or allergy to fish and/or shellfish Have sensitivity or allergy to soy and/or soybeans Have confirmed diagnosis of chronic fatigue syndrome or other diagnosis known to cause severe fatigue
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luke Peppone
Organizational Affiliation
University of Rochester NCORP Research Base
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wichita NCORP
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Cancer Research Consortium of West Michigan
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
University of Rochester NCORP Research Base
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Dayton NCORP
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45420
Country
United States
Facility Name
Greenville Health System NCORP
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Wisconsin NCORP
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35416182
Citation
Kleckner AS, Kleckner IR, Culakova E, Wojtovich AP, Klinedinst NJ, Kerns SL, Hardy SJ, Inglis JE, Padula GDA, Mustian KM, Janelsins MC, Dorsey SG, Saligan LN, Peppone LJ. Exploratory Analysis of Associations Between Whole Blood Mitochondrial Gene Expression and Cancer-Related Fatigue Among Breast Cancer Survivors. Nurs Res. 2022 Sep-Oct 01;71(5):411-417. doi: 10.1097/NNR.0000000000000598. Epub 2022 Apr 13.
Results Reference
derived
PubMed Identifier
32812824
Citation
Inglis JE, Kleckner AS, Lin PJ, Gilmore NJ, Culakova E, VanderWoude AC, Mustian KM, Fernandez ID, Dunne RF, Deutsch J, Peppone LJ. Excess Body Weight and Cancer-Related Fatigue, Systemic Inflammation, and Serum Lipids in Breast Cancer Survivors. Nutr Cancer. 2021;73(9):1676-1686. doi: 10.1080/01635581.2020.1807574. Epub 2020 Aug 19.
Results Reference
derived
Links:
URL
https://www.cancer.gov/publications/pdq
Description
Clinical trial summary from the National Cancer Institute's PDQ® database

Learn more about this trial

Omega-3 Fatty Acid in Reducing Cancer-Related Fatigue in Breast Cancer Survivors

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