Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00343382
Status:
COMPLETED
Last Update Posted:
2016-08-12
First Post:
2006-06-22
Brief Title:
Pilocarpine in Treating Vaginal Dryness in Patients With Breast Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Pilocarpine for Vaginal Dryness A Phase III Randomized Double Blind Placebo-Controlled Study
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 eg on a blinded clinical study concurrent aromatase inhibitor therapy yes vs no vs unknown eg 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000482969 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2009-00648 | REGISTRY | None | None |