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Pilocarpine in Treating Vagin...

Pilocarpine in Treating Vaginal Dryness in Patients With Breast Cancer

Last Updated: 2016-08-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2012-12-31

Brief Summary

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RATIONALE: Pilocarpine may decrease vaginal dryness and improve quality of life in patients with breast cancer It is not yet known whether pilocarpine is more effective than a placebo in treating vaginal dryness in patients with breast cancer.

PURPOSE: This randomized phase III trial is studying pilocarpine to see how well it works compared to a placebo in treating vaginal dryness in patients with breast cancer.

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Detailed Description

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OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to age (18 to 45 vs 46 to 55 vs 56 to 65 vs \> 65), concurrent tamoxifen therapy (yes vs no vs unknown \[e.g., on a blinded clinical study\]), concurrent aromatase inhibitor therapy (yes vs no vs unknown \[e.g., on a blinded clinical study\]), and perception of severity of vaginal symptoms at baseline (mild vs moderate vs severe). Patients are randomized to 1 of 4 treatment arms. The primary and secondary objectives of the study are described below.

OBJECTIVES:

Primary

* Determine the effectiveness of pilocarpine hydrochloride for alleviation of vaginal dryness in patients with breast cancer.

Secondary

* Evaluate any toxicities arising from pilocarpine hydrochloride in these patients.
* Evaluate quality of life of these patients treated with pilocarpine hydrochloride.

Quality of life was assessed at baseline and then weekly for 6 weeks.

Conditions

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Breast Cancer Vaginal Dryness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm I

Patients receive oral pilocarpine hydrochloride once a day for 3 days, twice a day for 3 days, three times a day for 3 days, and then 4 times a day for up to 6 weeks in the absence of unacceptable toxicity.

Group Type EXPERIMENTAL

pilocarpine hydrochloride

Intervention Type DRUG

Given orally

Arm II

Patients receive oral pilocarpine hydrochloride once a day for 3 days and then twice a day for up to 6 weeks in the absence of unacceptable toxicity.

Group Type EXPERIMENTAL

pilocarpine hydrochloride

Intervention Type DRUG

Given orally

Arm III

Patients receive oral placebo once a day for 3 days, twice a day for 3 days, three times a day for 3 days, and then 4 times a day for up to 6 weeks in the absence of unacceptable toxicity.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Given orally

Arm IV

Patients receive oral placebo once a day for 3 days and then twice a day for up to 6 weeks in the absence of unacceptable toxicity.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Given orally

Interventions

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pilocarpine hydrochloride

Given orally

Intervention Type DRUG

placebo

Given orally

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

14. Prior or concurrent pelvic radiation therapy
15. Prior radical pelvic surgery (TAH/BSO is allowed)
16. Use of beta adrenergic antagonists
17. Diagnosis of any of the following conditions:

* Vulvar and vaginal dysplasia
* Essential vulvodynia
* Vulvar vestibulitis
* Vaginal prolapse
* Bartholin cyst/abscess
* History of Bartholin gland surgery
* Lichen sclerosis
* Lichen planus of the vulvovaginal region
* Desquamative vaginitis

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles L. Loprinzi, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

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Aurora Presbyterian Hospital

Aurora, Colorado, United States

Site Status

Boulder Community Hospital

Boulder, Colorado, United States

Site Status