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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Dietary Supplement: glutamine
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glutamine Arm<br>Beginning on day 2 of course 1 of paclitaxel administration, patients receive oral glutamine three times daily for 4 days. | Dietary Supplement: glutamine<br>* Given orally<br>|
| Placebo Comparator: Placebo arm<br>Beginning on day 2 of course 1 of paclitaxel administration, patients receive oral placebo three times daily for 4 days. | Other: placebo<br>* Given orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, unspecified adult solid tumor, protocol specific