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

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 Overview

• Status: Unknown
• Conditions: Menopause; Climacteric; Menorrhagia, Menopausal
• Intervention / Treatment: Dietary supplement: 50 mg PYC and then placebo; Dietary supplement: 100 mg PYC and then placebo; Dietary supplement: Placebo and then 50 mg PYC; Dietary supplement: Placebo and then 100 mg PYC

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meg Christ; Phone Number: 503-413-8199; Email: mchrist@lhs.org
• Study Contact Backup: Name: Leslie Sorenson; Phone Number: 503-413-8199; Email: lmsorens@lhs.org

Study Locations

• United States
  • Oregon
    • Gresham, Oregon, United States, 97030
      • Recruiting
      • Legacy Mt. Hood Medical Center
      • Contact: Meg Christ; Phone Number: 503-413-8199; Email: oncologyresearch@lhs.org
    • Portland, Oregon, United States, 97219
      • Recruiting
      • Legacy Good Samaritan Medical Center
      • Contact: Meg Christ; Phone Number: 503-413-8199; Email: oncologyresearch@lhs.org
    • Tualatin, Oregon, United States, 97062
      • Recruiting
      • Legacy Meridian Park Medical Center
      • Contact: Meg Christ; Phone Number: 503-413-8199; Email: oncologyresearch@lhs.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Dietary supplement: 50 mg PYC and then placebo; 4 weeks on PYC, then 4 weeks on placebo
Experimental: 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	Dietary supplement: 100 mg PYC and then placebo; 4 weeks on PYC, then 4 weeks on placebo
Experimental: Group C - Placebo & PYC; Placebo for the first 4 weeks and then switch over to 50 mg PYC for the following 4 weeks	Dietary supplement: Placebo and then 50 mg PYC; 4 weeks on placebo, then 4 weeks on PYC
Experimental: Group D - Placebo & PYC; Placebo for the first 4 weeks and then switch over to 100mg PYC for the following 4 weeks	Dietary supplement: Placebo and then 100 mg PYC; 4 weeks on placebo, then 4 weeks of PYC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Legacy Health System
• Investigators: Principal Investigator: Reza Antoszewska, NP-C, Legacy Health

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Anticipated): September 15, 2019
• Study Completion (Anticipated): September 15, 2020

Study Registration Dates

• First Submitted: October 4, 2018
• First Submitted That Met QC Criteria: October 10, 2018
• First Posted (Actual): October 12, 2018

Study Record Updates

• Last Update Posted (Actual): October 12, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Hemorrhage; Menstruation Disturbances; Uterine Hemorrhage; Menorrhagia
• Other Study ID Numbers: PYC001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No