Back to resultsThe Use of Pycnogenol® to Alleviate Menopausal Symptoms Induced or Increased by Breast and Gynecological Cancer Treatments
Primary Purpose
Climacteric; Menorrhagia, Menopausal, Menopause
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
50 mg PYC and then placebo
100 mg PYC and then placebo
Placebo and then 50 mg PYC
Placebo and then 100 mg PYC
Sponsored by
About this trial
This is an interventional treatment trial for Climacteric; Menorrhagia, Menopausal
Eligibility Criteria
Inclusion Criteria:
- Patient currently is undergoing treatment for cancer
- Patient has menopausal symptoms induced either by surgical or medical (patient on tamoxifen or aromatase inhibitor) interventions for cancer
- > 18 years of age
- Willing to travel to a Legacy Health facility if necessary
- Agree to attend study visits outside of standard of care visits, if needed
- Willing to stop other supplements or medications that are aimed at treating menopausal symptoms at least 7 days before beginning study treatment
- Willing to engage in pre/post testing and survey/phone calls
Exclusion Criteria:
- Patient is currently undergoing chemotherapy treatment
- < 18 years of age
- Unable to comply with protocol
- Unable to provide written informed consent
- Investigator does not believe study participation is in the best interest of the patient
- Patient had concurrent menopausal symptoms prior to the start of cancer treatment
- Menopausal symptoms are unrelated to surgical or medical treatment of breast or gynecologic cancers
Sites / Locations
- Legacy Mt. Hood Medical CenterRecruiting
- Legacy Good Samaritan Medical CenterRecruiting
- Legacy Meridian Park Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Group A - PYC & Placebo
Group B - PYC & Placebo
Group C - Placebo & PYC
Group D - Placebo & PYC
Arm Description
50 mg of PYC for the first 4 weeks and then switch over to receive placebo for the following 4 weeks
100 mg of PYC for the first 4 weeks and then switch over to receive placebo for the following 4 weeks
Placebo for the first 4 weeks and then switch over to 50 mg PYC for the following 4 weeks
Placebo for the first 4 weeks and then switch over to 100mg PYC for the following 4 weeks
Outcomes
Primary Outcome Measures
Menopause Rating Scale (MRS)
The MRS will be used to evaluate the efficacy of PYC in decreasing menopausal symptoms as compared to placebo. The difference-from-baseline (DFB) score will be calculated by taking the composite MRS score at 10 weeks and 12 weeks compared to the MRS score at baseline to determine whether or not PYC reduces symptoms, if the effects last beyond actively taking PYC, and if so, how long. The purpose of multiple time point assessments is two-fold: first, some patients will be taking placebo and some will be taking active drug in the first month, and vice versa during the second month. Therefore, an assessment needs to be done at each timepoint, weeks 4 and 8. Second, we are interested in understanding how long the symptoms management may last without actively taking drug, which accounts for the 10 week and 12 week timepoints.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03704454
Brief Title
The Use of Pycnogenol® to Alleviate Menopausal Symptoms Induced or Increased by Breast and Gynecological Cancer Treatments
Official Title
The Use of Pycnogenol® to Alleviate Menopausal Symptoms Induced or Increased by Breast and Gynecological Cancer Treatments
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
September 15, 2019 (Anticipated)
Study Completion Date
September 15, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Legacy Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a pilot study to test whether PYC can improve climacteric symptoms for women who have experienced either surgically or medically induced menopause as part of their treatment for breast or gynecologic cancers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Climacteric; Menorrhagia, Menopausal, Menopause
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A - PYC & Placebo
Arm Type
Experimental
Arm Description
50 mg of PYC for the first 4 weeks and then switch over to receive placebo for the following 4 weeks
Arm Title
Group B - PYC & Placebo
Arm Type
Experimental
Arm Description
100 mg of PYC for the first 4 weeks and then switch over to receive placebo for the following 4 weeks
Arm Title
Group C - Placebo & PYC
Arm Type
Experimental
Arm Description
Placebo for the first 4 weeks and then switch over to 50 mg PYC for the following 4 weeks
Arm Title
Group D - Placebo & PYC
Arm Type
Experimental
Arm Description
Placebo for the first 4 weeks and then switch over to 100mg PYC for the following 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
50 mg PYC and then placebo
Intervention Description
4 weeks on PYC, then 4 weeks on placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
100 mg PYC and then placebo
Intervention Description
4 weeks on PYC, then 4 weeks on placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo and then 50 mg PYC
Intervention Description
4 weeks on placebo, then 4 weeks on PYC
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo and then 100 mg PYC
Intervention Description
4 weeks on placebo, then 4 weeks of PYC
Primary Outcome Measure Information:
Title
Menopause Rating Scale (MRS)
Description
The MRS will be used to evaluate the efficacy of PYC in decreasing menopausal symptoms as compared to placebo. The difference-from-baseline (DFB) score will be calculated by taking the composite MRS score at 10 weeks and 12 weeks compared to the MRS score at baseline to determine whether or not PYC reduces symptoms, if the effects last beyond actively taking PYC, and if so, how long. The purpose of multiple time point assessments is two-fold: first, some patients will be taking placebo and some will be taking active drug in the first month, and vice versa during the second month. Therefore, an assessment needs to be done at each timepoint, weeks 4 and 8. Second, we are interested in understanding how long the symptoms management may last without actively taking drug, which accounts for the 10 week and 12 week timepoints.
Time Frame
The MRS will be administered at baseline, after 4 weeks, after 8 weeks, 2 week follow-up (10 weeks), and 1 month follow up (12 weeks) with the intention of calculating DFB score at each time point.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patient currently is undergoing treatment for cancer
Patient has menopausal symptoms induced either by surgical or medical (patient on tamoxifen or aromatase inhibitor) interventions for cancer
> 18 years of age
Willing to travel to a Legacy Health facility if necessary
Agree to attend study visits outside of standard of care visits, if needed
Willing to stop other supplements or medications that are aimed at treating menopausal symptoms at least 7 days before beginning study treatment
Willing to engage in pre/post testing and survey/phone calls
Exclusion Criteria:
Patient is currently undergoing chemotherapy treatment
< 18 years of age
Unable to comply with protocol
Unable to provide written informed consent
Investigator does not believe study participation is in the best interest of the patient
Patient had concurrent menopausal symptoms prior to the start of cancer treatment
Menopausal symptoms are unrelated to surgical or medical treatment of breast or gynecologic cancers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meg Christ
Phone
503-413-8199
Email
mchrist@lhs.org
First Name & Middle Initial & Last Name or Official Title & Degree
Leslie Sorenson
Phone
503-413-8199
Email
lmsorens@lhs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Antoszewska, NP-C
Organizational Affiliation
Legacy Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Legacy Mt. Hood Medical Center
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meg Christ
Phone
503-413-8199
Email
oncologyresearch@lhs.org
Facility Name
Legacy Good Samaritan Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meg Christ
Phone
503-413-8199
Email
oncologyresearch@lhs.org
Facility Name
Legacy Meridian Park Medical Center
City
Tualatin
State/Province
Oregon
ZIP/Postal Code
97062
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meg Christ
Phone
503-413-8199
Email
oncologyresearch@lhs.org
12. IPD Sharing Statement
Learn more about this trial
The Use of Pycnogenol® to Alleviate Menopausal Symptoms Induced or Increased by Breast and Gynecological Cancer Treatments
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