Pain Clinical Trial
Official title:
A Double-blinded Pilot Study of Glutamine for the Prevention of Paclitaxel-Induced Myalgias and Arthralgias
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop
the growth of cancer cells, either by killing the cells or by stopping them from dividing.
Nutritional supplements, such as glutamine, may prevent side effects caused by chemotherapy.
PURPOSE: This randomized clinical trial is studying glutamine to see how well it works
compared to placebo in preventing myalgia and/or arthralgia in patients who are receiving
paclitaxel for cancer.
OBJECTIVES:
Primary
- Compare the efficacy of glutamine supplementation vs placebo, in terms of prevention of
paclitaxel-induced myalgia and/or arthralgia, in patients with cancer.
Secondary
- Compare the attenuation of myalgia and/or arthralgia in patients who experience myalgia
and/or arthralgia treated with these regimens.
OUTLINE: This is a randomized, double-blind, crossover, pilot study. Patients are randomized
to 1 of 2 treatment arms.
- Arm I: Beginning on day 2 of course 1 of paclitaxel administration, patients receive
oral glutamine three times daily for 4 days.
- Arm II: Beginning on day 2 of course 1 of paclitaxel administration, patients receive
oral placebo three times daily for 4 days.
Both arms crossover during course 2. In both arms, treatment continues in the absence of
unacceptable toxicity.
After completion of study treatment, patients are followed for 7-10 days.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
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