NCT00217724

Glutamine in Preventing Myalgia and/or Arthralgia in Patients Who Are Receiving Paclitaxel For Cancer

A Double-blinded Pilot Study of Glutamine for the Prevention of Paclitaxel-Induced Myalgias and Arthralgias

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pain
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	glutamine	Given orally
OTHER	placebo	Given orally

Timeline

• Start date: 1999-07-01
• Primary completion: 2009-01-01
• Completion: 2009-03-01
• First posted: 2005-09-22
• Last updated: 2017-05-09
• Results posted: 2010-09-24

Locations

1 site across 1 country: United States