Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Pilocarpine in Treating Vaginal Dryness in Patients With Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00343382
First received: June 22, 2006
Last updated: September 24, 2014
Last verified: September 2014

June 22, 2006
September 24, 2014
December 2006
July 2009   (final data collection date for primary outcome measure)
Average Vaginal Dryness Scores Via Area Under the Curve (AUC) Summary Statistics [ Time Frame: Baseline to Week 6 ] [ Designated as safety issue: No ]
Vaginal dryness was measured by the numerical analogue scale at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The average AUC values were calculated by dividing 6 from AUC values for participants who completed item on all 6 weeks. If a participant completed the item at baseline, week 1, 2 and 3 but did not complete the item at week 4 to week 6, the AUC values of the item was prorated, which is (((AUC values * 6) / 3) / 6). The average pro-rated AUC for vaginal dryness scores was compared in each of the Pilocarpine arms against the collective placebo arm.
Not Provided
Complete list of historical versions of study NCT00343382 on ClinicalTrials.gov Archive Site
  • Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 3.0 [ Time Frame: End of 6 weeks ] [ Designated as safety issue: Yes ]
    CTCAE Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.
  • Average AUC Summary Statistics for the Impact of Vaginal Dryness for Activities of Daily Living [ Time Frame: Baseline to Week 6 ] [ Designated as safety issue: No ]
    The impact of vaginal dryness for activities of daily living (ADL) were measured by the numerical analogue scales at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The average AUC values were calculated by dividing 6 from AUC values for participants who completed item on all 6 weeks. If a participant completed the item at baseline, week 1, 2 and 3 but did not complete the item at week 4 to week 6, the AUC values of the item was prorated, which is (((AUC values * 6) / 3) / 6). The average pro-rated AUC scores was compared in each of the Pilocarpine arms against the collective placebo arm.
  • Change From Baseline to Week 6 on the Impact of Vaginal Dryness for Activities of Daily Living Scores [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
    The impact of vaginal dryness for activities of daily living (ADL) were measured by the numerical analogue scales at baseline and through the six weeks of treatment. The item scores was transformed into 0 to 100 scales with 0=poor quality of life (QOL) and 100=best possible QOL. The change from baseline scores was calculated by subtracting the baseline item scores from the scores at 6 week.
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Not Provided
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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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
  • Breast Cancer
  • Vaginal Dryness
  • 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
201
December 2012
July 2009   (final data collection date for primary outcome measure)

Required Characteristics:

  1. Adult post menopausal women or women with no childbearing potential (≥ 18 years) with a history of breast cancer (currently no evidence of disease) or women who do not want to take vaginal estrogen for a fear of an increased risk of breast cancer. Postmenopausal status will be determined by the primary physician.
  2. Significant vaginal complaints defined as persistent vaginal dryness and/or itching of sufficient severity to make a patient desire therapeutic intervention. Symptoms should have been present ≥ 2 months prior to randomization.
  3. Life expectancy > 6 months
  4. Ability to complete questionnaire(s) by themselves or with assistance.

Contraindications:

  1. Initiation or discontinuation of tamoxifen or aromatase inhibitors ≤2 months prior to randomization or plans to initiate or discontinue any of these medications during the 6-week study.
  2. Active vaginal infection
  3. Concurrent chemotherapy
  4. Acute iritis
  5. Current or past use of pilocarpine (regardless of purpose)
  6. Planned use of any vaginal preparations during the study period (including any over the counter or herbal preparations). Note: Lubricants used during sexual intercourse are permitted.
  7. Use of any vaginal preparations ≤ 1 week prior to study entry (Exception: If patient has used vaginal preparations during the previous week but will stop, then they can be placed on study with plans to start with pretreatment questionnaire one week later). Note: Lubricants used during sexual intercourse are permitted.
  8. Current (≤ 4weeks prior to randomization), or planned during the study period, use of any estrogen product.
  9. A diagnosis of asthma, COPD, CAD or narrow angle glaucoma, or known cholelithiasis.
  10. Hepatic or renal insufficiency defined as a history of an elevation of SGOT ≥1.5 x ULN or creatinine ≥ 1.5 x ULN within the past year.
  11. Concurrent use of other anticholinergics
  12. Use of pharmacologic soy preparations
  13. Known history of cardiac arrhythmia. (Patients with occasional PVC's or PAC's that do not require treatment are eligible.)
  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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00343382
NCCTG-N04CA, NCI-2009-00648, CDR0000482969
Yes
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Charles L. Loprinzi, MD Mayo Clinic
Alliance for Clinical Trials in Oncology
September 2014

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