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

Launched by OHSU KNIGHT CANCER INSTITUTE · Sep 20, 2005

Keywords

ClinConnect Summary

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: Be...

Gender

ALL

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.