Pilocarpine in Treating Vaginal Dryness in Patients With Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
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

June 22, 2006
August 14, 2012
December 2006
July 2009   (final data collection date for primary outcome measure)
Efficacy [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00343382 on ClinicalTrials.gov Archive Site
  • Toxicities [ Designated as safety issue: Yes ]
  • Quality of life [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Pilocarpine in Treating Vaginal Dryness in Patients With Breast Cancer
Pilocarpine for Vaginal Dryness: A Phase III Randomized, Double Blind, Placebo-Controlled Study

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.

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.

Interventional
Phase 3
Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care
  • Breast Cancer
  • Sexual Dysfunction
  • Sexuality and Reproductive Issues
  • Drug: pilocarpine hydrochloride
    Given orally
  • Other: placebo
    Given orally
  • 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.
    Intervention: Drug: pilocarpine hydrochloride
  • 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.
    Intervention: Drug: pilocarpine hydrochloride
  • 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.
    Intervention: Other: placebo
  • 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.
    Intervention: Other: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
192
Not Provided
July 2009   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00343382
CDR0000482969, NCCTG-N04CA
Not Provided
Charles L. Loprinzi, North Central Cancer Treatment Group
North Central Cancer Treatment Group
National Cancer Institute (NCI)
Study Chair: Charles L. Loprinzi, MD Mayo Clinic
Investigator: Ernie P. Balcueva, MD Balcueva Clinic
Investigator: Lisa Kottschade, RN, MSN, CNP Mayo Clinic
National Cancer Institute (NCI)
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP