Page 12 - Delaware Medical Journal - March 2016
P. 12
CANCER CLINICAL TRIAL
NCI PROTOCOL OF THE MONTH
Alliance A221102: Randomized Double-Blind Placebo Controlled Study of Testosterone in the Adjuvant Treatment of Postmenopausal Women
with Aromatase Inhibitor Induced Arthralgias
The objectives of the trial are: Primary Objective:
To determine whether testosterone will reduce AI-induced arthralgia and associated joint symptoms.
Secondary Objective:
Ancillary Objectives:
1. To explore whether testosterone will reduce AI-induced arthralgias and associated joint symptoms and their interference with activity.
2.
3. To explore whether testosterone will modify libido or change quality of life.
4.
population.
Eligibilty:
throughout the duration of study.
Must have BOTH
be caused by their aromatase inhibitor.
May not have residual or recurrent cancer.
Treatment:
Patients will be randomized in a double-blind fashion to either:
1.
2. 3. 4. 5.
Testosterone Topical Gel 10.4mg/0.264ml daily for 6 months. Or
Placebo Topical Gel 0.264ml daily for 6 months
Assessment of AI-associated arthralgia and associated joint symptoms will be measured by the change from baseline using data
For information regarding clinical trials
or if you would like to have the list of open protocols e-mailed to you, akee@christianacare.org.
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Del Med J | March 2016 | Vol. 88
| No. 3
