The Use of Pycnogenol® to Alleviate Menopausal Symptoms Induced or Increased by Breast and Gynecological Cancer Treatments
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Legacy Health System
- Enrollment
- 40
- Locations
- 3
- Primary Endpoint
- Menopause Rating Scale (MRS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Group A - PYC & Placebo
50 mg of PYC for the first 4 weeks and then switch over to receive placebo for the following 4 weeks
Intervention: 50 mg PYC and then placebo (Dietary Supplement)
Group B - PYC & Placebo
100 mg of PYC for the first 4 weeks and then switch over to receive placebo for the following 4 weeks
Intervention: 100 mg PYC and then placebo (Dietary Supplement)
Group C - Placebo & PYC
Placebo for the first 4 weeks and then switch over to 50 mg PYC for the following 4 weeks
Intervention: Placebo and then 50 mg PYC (Dietary Supplement)
Group D - Placebo & PYC
Placebo for the first 4 weeks and then switch over to 100mg PYC for the following 4 weeks
Intervention: Placebo and then 100 mg PYC (Dietary Supplement)
Outcomes
Primary Outcomes
Menopause Rating Scale (MRS)
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.
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 Outcomes
No secondary outcomes reported
Investigators
Reza Antoszewska
Legacy Health Foundation
Legacy Health System