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Search / Trial NCT00217724

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

Launched by OHSU KNIGHT CANCER INSTITUTE · Sep 20, 2005

Trial Information

Current as of July 24, 2025

Terminated

Keywords

Unspecified Adult Solid Tumor, Protocol Specific Pain

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.

About Ohsu Knight Cancer Institute

The OHSU Knight Cancer Institute is a leading research and treatment center dedicated to advancing cancer care through innovative clinical trials and groundbreaking research. Part of Oregon Health & Science University, the institute is recognized for its multidisciplinary approach, combining expertise in oncology, genomics, and patient care to develop novel therapies and improve treatment outcomes. With a commitment to translating scientific discoveries into clinical applications, the OHSU Knight Cancer Institute strives to enhance the quality of life for cancer patients while fostering collaboration among researchers, clinicians, and the community.

Locations

Portland, Oregon, United States

Patients applied

0 patients applied

Trial Officials

Joseph Bubalo, PharmD, BCPS, BCOP

Study Chair

OHSU Knight Cancer Institute

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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