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

NCT ID: NCT00217724

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-07-31
• Study Completion Date: 2009-03-31

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.

Conditions

Pain; Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Glutamine Arm

Beginning on day 2 of course 1 of paclitaxel administration, patients receive oral glutamine three times daily for 4 days.

Group Type: EXPERIMENTAL

glutamine

Intervention Type: DIETARY_SUPPLEMENT

Given orally

Placebo arm

Beginning on day 2 of course 1 of paclitaxel administration, patients receive oral placebo three times daily for 4 days.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

Given orally

Interventions

glutamine

Given orally

Intervention Type: DIETARY_SUPPLEMENT

placebo

Given orally

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Signed informed patient consent
• Adult patients (Age > 18 years old) with a neoplastic disorder requiring paclitaxel as part of therapy, whether curative or palliative intent.
• Patients must have > 2 additional planned courses of paclitaxel.
• Patients may be out-patient or in-patient at the time of enrollment.
• Patient must have had myalgias and/or arthralgias with the most recent course(s) of paclitaxel. Paclitaxel must be being administered over 3 hours or less for each infusion.
• Patients may have chronic pain but they must be able to differentiate it from either myalgias or arthralgias and be on a stable medication regimen for pain management.
• Eastern Cooperative Group (ECOG) Performance status score < 3
• If consenting for the laboratory portion of the study the participant must have normal creatinine phosphokinase within 14 days of study entry.
• The patient, if sexually active, must be willing to agree to use an approved form of birth control.

Exclusion Criteria

• The patient has received another investigational drug within the past 30 days.
• No myalgias or arthralgias in prior paclitaxel courses.
• The patient has uncontrolled (over the last 30 days), clinically significant confounding medical conditions such as rheumatoid disease, fibromyalgia, or chronic fatigue syndrome. Also if the patient has a viral infection, cold symptoms, fever (> 38 C -degrees celsius) or influenza.
• Patients with existing neuropathies or neurologic disorders which would prevent them from accurately assessing the onset or extent of myalgias and arthralgias.
• The patient has had significant medical intervention in the last 30 days
• The patient is pregnant or lactating.
• Patients who are unable to take oral medications or with medical conditions that might inhibit their ability to absorb protein from the gastrointestinal tract.
• Patients who are unwilling to abstain from additional protein supplements of any kind other than that obtained through "normal" dietary intake.
• Patients required to take nonsteroidal anti-inflammatory agents (NSAIDS), antioxidant vitamins, and unable or unwilling to abstain from them for 1 week prior to and during glutamine/placebo therapy.
• Patients with metabolic errors or abnormalities of protein metabolism.
• Patients with a history of blood urea nitrogen level > 2 times normal with a normal serum creatinine.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OHSU Knight Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Joseph Bubalo

PharmD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph Bubalo, PharmD, BCPS, BCOP

Role: STUDY_CHAIR

OHSU Knight Cancer Institute

Locations

OHSU Knight Cancer Institute

Portland, Oregon, United States

Countries

United States

Other Identifiers

OHSU-ONC-99037-L

Identifier Type: OTHER

Identifier Source: secondary_id

1252

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000446073

Identifier Type: -

Identifier Source: org_study_id