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

Legacy Health System

Status: Unknown

Conditions: Menopause; Climacteric; Menorrhagia, Menopausal

Treatments: Dietary Supplement: 50 mg PYC and then placebo; Dietary Supplement: 100 mg PYC and then placebo; Dietary Supplement: Placebo and then 100 mg PYC; Dietary Supplement: Placebo and then 50 mg PYC

Study type: Interventional

Funder types: Other

Identifiers

NCT03704454

PYC001

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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40 participants in 4 patient groups

Group A - PYC & Placebo

Experimental group

Description:

50 mg of PYC for the first 4 weeks and then switch over to receive placebo for the following 4 weeks

Treatment:

Dietary Supplement: 50 mg PYC and then placebo

Group B - PYC & Placebo

Experimental group

Description:

100 mg of PYC for the first 4 weeks and then switch over to receive placebo for the following 4 weeks

Treatment:

Dietary Supplement: 100 mg PYC and then placebo

Group C - Placebo & PYC

Experimental group

Description:

Placebo for the first 4 weeks and then switch over to 50 mg PYC for the following 4 weeks

Treatment:

Dietary Supplement: Placebo and then 50 mg PYC

Group D - Placebo & PYC

Experimental group

Description:

Placebo for the first 4 weeks and then switch over to 100mg PYC for the following 4 weeks

Treatment:

Dietary Supplement: Placebo and then 100 mg PYC