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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03704454
Recruitment Status : Recruiting
First Posted : October 12, 2018
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Reza Antoszewska, Legacy Health System

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.

Condition or disease Intervention/treatment Phase
Climacteric; Menorrhagia, Menopausal Menopause 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Use of Pycnogenol® to Alleviate Menopausal Symptoms Induced or Increased by Breast and Gynecological Cancer Treatments
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : September 15, 2019
Estimated Study Completion Date : September 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03704454


Contacts
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Contact: Meg Christ 503-413-8199 mchrist@lhs.org
Contact: Leslie Sorenson 503-413-8199 lmsorens@lhs.org

Locations
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United States, Oregon
Legacy Mt. Hood Medical Center Recruiting
Gresham, Oregon, United States, 97030
Contact: Meg Christ    503-413-8199    oncologyresearch@lhs.org   
Legacy Good Samaritan Medical Center Recruiting
Portland, Oregon, United States, 97219
Contact: Meg Christ    503-413-8199    oncologyresearch@lhs.org   
Legacy Meridian Park Medical Center Recruiting
Tualatin, Oregon, United States, 97062
Contact: Meg Christ    503-413-8199    oncologyresearch@lhs.org   
Sponsors and Collaborators
Legacy Health System
Investigators
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Principal Investigator: Reza Antoszewska, NP-C Legacy Health

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Responsible Party: Reza Antoszewska, Legacy Health Foundation, Legacy Health System
ClinicalTrials.gov Identifier: NCT03704454    
Other Study ID Numbers: PYC001
First Posted: October 12, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Menorrhagia
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Hemorrhage
Pathologic Processes
Menstruation Disturbances
Pycnogenols
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Platelet Aggregation Inhibitors