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NCT00343382 · REGISTRY CONDITION SEARCH

Pilocarpine in Treating Vaginal Dryness in Patients With Breast Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2016-08-12

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Average Vaginal Dryness Scores Via Area Under the Curve (AUC) Summary Statistics

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outcome · POSTED

Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 3.0

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outcome · POSTED

Average AUC Summary Statistics for the Impact of Vaginal Dryness for Activities of Daily Living

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outcome · POSTED

Change From Baseline to Week 6 on the Impact of Vaginal Dryness for Activities of Daily Living Scores

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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
healthy Volunteers
false
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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 Names
    1. Drug: pilocarpine hydrochloride
    label
    Arm I
    type
    EXPERIMENTAL
  2. description
    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 Names
    1. Drug: pilocarpine hydrochloride
    label
    Arm II
    type
    EXPERIMENTAL
  3. description
    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 Names
    1. Other: placebo
    label
    Arm III
    type
    PLACEBO_COMPARATOR
  4. description
    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 Names
    1. Other: placebo
    label
    Arm IV
    type
    PLACEBO_COMPARATOR
interventions
  1. arm Group Labels
    1. Arm I
    2. Arm II
    description
    Given orally
    name
    pilocarpine hydrochloride
    type
    DRUG
  2. arm Group Labels
    1. Arm III
    2. Arm IV
    description
    Given orally
    name
    placebo
    type
    OTHER
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
DOUBLE
who Masked
  1. PARTICIPANT
  2. INVESTIGATOR
primary Purpose
SUPPORTIVE_CARE
Enrollment
count
201
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Average Vaginal Dryness Scores Via Area Under the Curve (AUC) Summary Statistics
    time Frame
    Baseline to Week 6
secondary Outcomes
  1. description
    CTCAE Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.
    measure
    Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 3.0
    time Frame
    End of 6 weeks
  2. description
    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.
    measure
    Average AUC Summary Statistics for the Impact of Vaginal Dryness for Activities of Daily Living
    time Frame
    Baseline to Week 6
  3. description
    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.
    measure
    Change From Baseline to Week 6 on the Impact of Vaginal Dryness for Activities of Daily Living Scores
    time Frame
    Baseline and Week 6
Full study description
brief Summary
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.
detailed Description
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.
Source references
references
  1. citation
    Loprinzi CL, Balcueva EP, Liu H, Sloan JA, Kottschade LA, Stella PJ, Carlson MD, Moore DF Jr, Zon RT, Levitt R, Jaslowski AJ. A phase III randomized, double-blind, placebo-controlled study of pilocarpine for vaginal dryness: North Central Cancer Treatment group study N04CA. J Support Oncol. 2011 May-Jun;9(3):105-12. doi: 10.1016/j.suponc.2011.02.005.
    pmid
    21702402
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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      offset unit
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      query cond
      Vaginal Cancer
      query disease state id
      ds-vaginal-cancer
      source file
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    Preserved source evidence · Not medical advice