Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00198250
Status:
COMPLETED
Last Update Posted:
2008-11-14
First Post:
2005-09-15
Brief Title:
Venlafaxine for Hot Flashes After Breast Cancer
Sponsor:
Indiana University School of Medicine
Organization:
Indiana University
Study Overview
Official Title:
Venlafaxine for Hot Flashes After Breast Cancer
Status:
COMPLETED
Status Verified Date:
2008-11
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:
The purpose of this study is to evaluate Venlafaxine as a treatment option for hot flashes in breast cancer survivors The goals of this study are to assess the effectiveness and toxicity of venlafaxine hydrochloride and identify the psychological behavioral and physical outcomes associated with relief of hot flashes in women following treatment for breast cancer
Detailed Description:
Hot flashes are the most severe and fourth most prevalent menopausal symptom reported by women with breast cancer Hot flashes affect over 65 of this population with 59 rating the symptom as severe and 44 reporting they are extremely distressed by the symptom Despite the high prevalence severity and distress associated with this symptom the scientific basis for managing hot flashes in women with breast cancer is limited This randomized double-blind placebo-controlled crossover trial examines the effectiveness and toxicity of sustained release venlafaxine hydrochloride 375 mg po qd on hot flashes in women following treatment for breast cancer Venlafaxine is a phenylethylamine derivative that potently inhibits the reuptake of neuronal serotonin and norepinephrine and weakly inhibits the reuptake of dopamine A secondary aim of this project is to examine the impact of hot flashes on psychological behavioral and physical outcomes This study is based on the Wickham Symptom Management Model which depicts interrelationships between symptoms symptom management strategies and symptom management outcomes Participants n 80 who are at least one month post-completion of surgery radiation andor chemotherapy and who have been on tamoxifen if prescribed for at least six weeks will complete a two-week baseline hot flash assessment and be randomized to one arm of the crossover trial At the end of the first six-week arm participants will crossover to the opposite study arm for an additional six weeks Outcomes to be assessed include effectiveness of the intervention hot flash frequency severity distress and magnitude toxicity of the intervention subjective preference side effects psychological outcomes mood disturbance behavioral outcomes quality of life interference with daily activities and physical outcomes fatigue and sleep disturbance Hot flashes will be measured daily using a subjective prospective diary methodology and weekly using objective state-of-the art 24-hour physiological monitoring of sternal skin conductance Other outcomes will be measured weekly Compliance with the interventionplacebo will be assessed weekly using medication blister pack cards Timing of outcome assessments is based on limitations of the physiological monitoring device and expected timing of treatment effects Summary statistics ie mean slope maximum response range proportion achievable difference will be used to effectively reduce the design to a 2 X 2 crossover and data will be analyzed accordingly ie t-tests linear regression GEE mixed model Study findings will significantly contribute to the scientific basis of hot flash management in women following treatment for breast cancer
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 |
|---|---|---|---|
| NINRNIH R01 NR05261 | None | None | None |