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Pilocarpine in Treating Vaginal Dryness in Patients With Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00343382
First received: June 22, 2006
Last updated: August 14, 2012
Last verified: August 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Sexual Dysfunction
Sexuality and Reproductive Issues
 Drug: pilocarpine hydrochloride
Other: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care
Official Title: Pilocarpine for Vaginal Dryness: A Phase III Randomized, Double Blind, Placebo-Controlled Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Efficacy [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicities [ Designated as safety issue: Yes ]
  • Quality of life [ Designated as safety issue: No ]

Estimated Enrollment: 192
Study Start Date: December 2006
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 Drug: pilocarpine hydrochloride
Given orally
Experimental: 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.
 Drug: pilocarpine hydrochloride
Given orally
Placebo Comparator: 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.
 Other: placebo
Given orally
Placebo Comparator: 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.
 Other: placebo
Given orally

Detailed Description:

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.

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.

  • 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.
  • 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.
  • 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.
  • 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.

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

PROJECTED ACCRUAL: A total of 192 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Meets 1 of the following criteria:

    • History of breast cancer (currently no evidence of disease)
    • Unwilling to take vaginal estrogen due to fear of an increased risk of breast cancer

  • Significant vaginal complaints, defined as persistent vaginal dryness and/or itching of sufficient severity to make a patient desire therapeutic intervention

    • Symptoms present ≥ 2 months prior to randomization
  • No active vaginal infection
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Female
  • Postmenopausal or no childbearing potential
  • Life expectancy > 6 months
  • SGOT < 1.5 times upper limit of normal (ULN) for the past year
  • Creatinine ≤ 1.5 times ULN for the past year
  • Able to complete questionnaire(s) alone or with assistance

  • No diagnosis of any of the following:

    • Asthma
    • Chronic obstructive pulmonary disease
    • Coronary artery disease
    • Narrow angle glaucoma
    • Known cholelithiasis
    • Vulvar and vaginal dysplasia
    • Essential vulvodynia
    • Vulvar vestibulitis
    • Vaginal prolapse
    • Bartholin cyst/abscess
    • Lichen sclerosis
    • Lichen planus of the vulvovaginal region
    • Desquamative vaginitis
  • No known history of cardiac arrhythmia
  • No history of Bartholin gland surgery
  • No acute iritis

PRIOR CONCURRENT THERAPY:

  • No initiation or discontinuation of tamoxifen or aromatase inhibitors ≤ 2 months prior to study randomization or plans to initiate or discontinue any of these medications during the 6-week study period

  • More than 1 week since prior vaginal preparations*

    • If patient has used vaginal preparations during the previous week but is planning to stop, then the patient may enter the study with plans to start with pretreatment questionnaire 1 week later NOTE: *Lubricants used during sexual intercourse are allowed

  • No prior radical pelvic surgery

    • Total abdominal hysterectomy with bilateral salpingo-oophorectomy (TAH/BSO) allowed
  • No prior pilocarpine hydrochloride
  • No prior or concurrent pelvic radiotherapy
  • More than 4 weeks since prior and no concurrent estrogen products
  • No concurrent vaginal preparations (including any over-the-counter or herbal preparations)
  • No other concurrent anticholinergics
  • No concurrent chemotherapy
  • No concurrent hormonal therapy, including progestationally-coated intrauterine devices (IUDs)
  • No concurrent pharmacologic soy preparations
  • No concurrent surgery and/or radiotherapy for recurrent cancer
  • No beta adrenergic antagonists
  • No other concurrent treatment for vaginal dryness
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00343382

  Show 192 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
National Cancer Institute (NCI)
Investigators
Study Chair: Charles L. Loprinzi, MD Mayo Clinic
Investigator: Ernie P. Balcueva, MD Balcueva Clinic
Investigator: Lisa Kottschade, RN, MSN, CNP Mayo Clinic
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
Loprinzi CL, Balcueva EP, Liu H, et al.: A phase III randomized, double-blind, placebo-controlled study of pilocarpine for vaginal dryness: NCCTG study N04CA. [Abstract] J Clin Oncol 28 (Suppl15): A-9024, 2010.

Responsible Party: Charles L. Loprinzi, North Central Cancer Treatment Group
ClinicalTrials.gov Identifier: NCT00343382     History of Changes
Other Study ID Numbers: CDR0000482969, NCCTG-N04CA
Study First Received: June 22, 2006
Last Updated: August 14, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
sexuality and reproductive issues
sexual dysfunction
recurrent breast cancer
stage I breast cancer
stage II breast cancer
 stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Sexual Dysfunctions, Psychological
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Sexual and Gender Disorders
Mental Disorders
Pilocarpine
Miotics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013