The Use of Pycnogenol® to Alleviate Menopausal Symptoms Induced or Increased by Breast and Gynecological Cancer Treatments

Not Applicable

Interventions: Dietary Supplement: 100 mg PYC and then placebo
Dietary Supplement: Placebo and then 100 mg PYC
Dietary Supplement: Placebo and then 50 mg PYC
Dietary Supplement: 50 mg PYC and then placebo

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Group B - PYC & Placebo	100 mg PYC and then placebo	100 mg of PYC for the first 4 weeks and then switch over to receive placebo for the following 4 weeks
Group D - Placebo & PYC	Placebo and then 100 mg PYC	Placebo for the first 4 weeks and then switch over to 100mg PYC for the following 4 weeks
Group C - Placebo & PYC	Placebo and then 50 mg PYC	Placebo for the first 4 weeks and then switch over to 50 mg PYC for the following 4 weeks
Group A - PYC & Placebo	50 mg PYC and then placebo	50 mg of PYC for the first 4 weeks and then switch over to receive placebo for the following 4 weeks

Primary Outcome Measures

Name	Time	Method
Menopause Rating Scale (MRS)	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 Outcome Measures

Name	Time	Method

Locations (3): Legacy Meridian Park Medical Center
🇺🇸
Tualatin, Oregon, United States
Legacy Good Samaritan Medical Center
🇺🇸
Portland, Oregon, United States
Legacy Mt. Hood Medical Center
🇺🇸
Gresham, Oregon, United States

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