A Double-blinded Pilot Study of Glutamine for the Prevention of Paclitaxel-Induced Myalgias and Arthralgias
- Compare the efficacy of glutamine supplementation vs placebo, in terms of prevention of
paclitaxel-induced myalgia and/or arthralgia, in patients with cancer.
- 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
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Number of Participants With Response From Glutamine Preventing Paclitaxel Induced Myalgias or Arthralgias After 2 Courses of Chemotherapy
Complete Response (CR): Complete absence of myalgias or arthralgias Partial Response (PR): Myalgias and/or arthralgias occur but are attenuated in the cycle in which they receive active therapy by > 50% Stable Disease (SD): Less than 25% change in incidence, duration, or severity of myalgias/arthralgias Progressive Disease (PD): Symptoms worsen by >25% from baseline scores
2 courses of chemotherapy (6 weeks)
Joseph Bubalo, PharmD, BCPS, BCOP
OHSU Knight Cancer Institute
United States: Federal Government
|OHSU Knight Cancer Institute||Portland, Oregon 97239|