The Use of Pycnogenol® to Alleviate Menopausal Symptoms Induced or Increased by Breast and Gynecological Cancer Treatments
1 other identifier
interventional
40
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2018
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2018
CompletedFirst Submitted
Initial submission to the registry
October 4, 2018
CompletedFirst Posted
Study publicly available on registry
October 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2020
CompletedOctober 12, 2018
October 1, 2018
12 months
October 4, 2018
October 10, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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.
Study Arms (4)
Group A - PYC & Placebo
EXPERIMENTAL50 mg of PYC for the first 4 weeks and then switch over to receive placebo for the following 4 weeks
Group B - PYC & Placebo
EXPERIMENTAL100 mg of PYC for the first 4 weeks and then switch over to receive placebo for the following 4 weeks
Group C - Placebo & PYC
EXPERIMENTALPlacebo for the first 4 weeks and then switch over to 50 mg PYC for the following 4 weeks
Group D - Placebo & PYC
EXPERIMENTALPlacebo for the first 4 weeks and then switch over to 100mg PYC for the following 4 weeks
Interventions
4 weeks on PYC, then 4 weeks on placebo
4 weeks on PYC, then 4 weeks on placebo
4 weeks on placebo, then 4 weeks on PYC
4 weeks on placebo, then 4 weeks of PYC
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Legacy Mt. Hood Medical Center
Gresham, Oregon, 97030, United States
Legacy Good Samaritan Medical Center
Portland, Oregon, 97219, United States
Legacy Meridian Park Medical Center
Tualatin, Oregon, 97062, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Reza Antoszewska, NP-C
Legacy Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Legacy Health Foundation
Study Record Dates
First Submitted
October 4, 2018
First Posted
October 12, 2018
Study Start
October 1, 2018
Primary Completion
September 15, 2019
Study Completion
September 15, 2020
Last Updated
October 12, 2018
Record last verified: 2018-10