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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00198250 |
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Date of registration:
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15/09/2005 |
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Primary sponsor: |
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Public title:
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Venlafaxine for Hot Flashes After Breast Cancer
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Scientific title:
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Venlafaxine for Hot Flashes After Breast Cancer |
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Date of first enrolment:
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May 2000 |
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Target sample size:
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75 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00198250 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Janet S Carpenter, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Indiana University School of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- women at least 21 years of age
- willing and able to provide informed consent
- first time diagnosis of breast cancer
- no other history of cancer
- considered disease free at time of study enrollment
- at least four weeks post-completion of surgery, radiation, and/or chemotherapy for
non-metastatic cancer
- experiencing daily hot flashes
- desirous of treatment for hot flashes, but not concurrently using any other hot flash
treatments
- living within 60 miles of Indianapolis
- able to read, write and speak English
Exclusion Criteria:
- current treatment with antidepressants for depression, neuropathic pain or hot
flashes
- diagnosis of metastatic breast cancer (stage IV)
- treatment for hot flashes within the past four weeks, including (a) soy supplements;
(b) botanicals, such as dong quai (Angelica sinensis), black cohosh, ginseng, gotu
kola, licorice root, chaste tree, sage, or wild yam root; (c) vitamin E; or (d)
prescription medications, such as clonidine hydrochloride or megestrol acetate.
Age minimum:
21 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Intervention(s)
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Drug: venlafaxine
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Primary Outcome(s)
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Assess the effectiveness venlafaxine hydrochloride versus placebo in alleviating hot flash frequency, severity, distress, and magnitude in women following treatment for breast cancer.
[Time Frame: completed]
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Secondary Outcome(s)
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Identify the psychological, behavioral, and physical outcomes associated with relief of hot flashes in women following treatment for breast cancer.
[Time Frame: completed]
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Secondary ID(s)
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0308-07
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NINR/NIH R01 NR05261
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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