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

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.

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.