Pilocarpine in Treating Vaginal Dryness in Patients With Breast Cancer - Full Text View

Sponsor:	North Central Cancer Treatment Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00343382

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 and Infertility Sexuality and Reproductive Issues	Drug: pilocarpine hydrochloride Other: placebo	Phase III

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Infertility

Drug Information available for: Pilocarpine hydrochloride Pilocarpine Pilocarpine nitrate

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
Estimated Primary Completion Date:	June 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:	July 17, 2010
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

sexuality and reproductive issues
sexual dysfunction and infertility
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
Infertility
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Genital Diseases, Male
Genital Diseases, Female
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 February 09, 2012