The Use of Pycnogenol® to Alleviate Menopausal Symptoms Induced or Increased by Breast and Gynecological Cancer Treatments
NCT ID: NCT03704454
Last Updated: 2018-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2018-10-01
2020-09-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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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
50 mg PYC and then placebo
4 weeks on PYC, then 4 weeks on placebo
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
100 mg PYC and then placebo
4 weeks on PYC, then 4 weeks on placebo
Group C - Placebo & PYC
Placebo for the first 4 weeks and then switch over to 50 mg PYC for the following 4 weeks
Placebo and then 50 mg PYC
4 weeks on placebo, then 4 weeks on PYC
Group D - Placebo & PYC
Placebo for the first 4 weeks and then switch over to 100mg PYC for the following 4 weeks
Placebo and then 100 mg PYC
4 weeks on placebo, then 4 weeks of PYC
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* \< 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
18 Years
99 Years
FEMALE
Yes
Sponsors
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Legacy Health System
OTHER
Responsible Party
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Reza Antoszewska
Legacy Health Foundation
Principal Investigators
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Reza Antoszewska, NP-C
Role: PRINCIPAL_INVESTIGATOR
Legacy Health
Locations
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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, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PYC001
Identifier Type: -
Identifier Source: org_study_id
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