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

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03704454
• Other study ID #: PYC001
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: September 15, 2020

Study information

• Verified date: October 2018
• Source: Legacy Health System
• Contact: Meg Christ
• Phone: 503-413-8199
• Email: mchrist[@]lhs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 15, 2020
• Est. primary completion date: September 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 99 Years

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

Related Conditions & MeSH terms

• Climacteric; Menorrhagia, Menopausal
• Menopause
• Menorrhagia

Intervention

Dietary Supplement:
• 50 mg PYC and then placebo
4 weeks on PYC, then 4 weeks on placebo
• 100 mg PYC and then placebo
4 weeks on PYC, then 4 weeks on placebo
• Placebo and then 50 mg PYC
4 weeks on placebo, then 4 weeks on PYC
• Placebo and then 100 mg PYC
4 weeks on placebo, then 4 weeks of PYC

Locations

Country	Name	City	State
United States	Legacy Mt. Hood Medical Center	Gresham	Oregon
United States	Legacy Good Samaritan Medical Center	Portland	Oregon
United States	Legacy Meridian Park Medical Center	Tualatin	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Legacy Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.