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

Not Applicable

Terminated

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Pain
• Interventions: Other: placebo; Dietary Supplement: glutamine

• Registration Number: NCT00217724
• Lead Sponsor: OHSU Knight Cancer Institute

Brief 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.

Study Timeline

• Study Start: 1999-07
• Study First Submitted: 2005-09-20
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-22
• Primary Completion: 2009-01
• Study Completion: 2009-03
• Results First Submitted: 2010-06-10
• Results First Submitted QC: 2010-08-25
• Results First Posted: 2010-09-24
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-07
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo arm	placebo	Beginning on day 2 of course 1 of paclitaxel administration, patients receive oral placebo three times daily for 4 days.
Glutamine Arm	glutamine	Beginning on day 2 of course 1 of paclitaxel administration, patients receive oral glutamine three times daily for 4 days.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Response From Glutamine Preventing Paclitaxel Induced Myalgias or Arthralgias After 2 Courses of Chemotherapy	2 courses of chemotherapy (6 weeks)	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

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Attenuation of Myalgias or Arthralgias Not Receiving Glutamine as Measured by Pain Scale Diaries on Days 1 and 3 of Courses 1 and 2	Duration of participation on study (up to one year)

Trial Locations

Locations (1)

OHSU Knight Cancer Institute; 🇺🇸 Portland, Oregon, United States