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

NCT00217724 | Terminated Results DMC

• 3 other identifiers: CDR0000446073OHSU-ONC-99037-L1252
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific; pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (2)

Glutamine Arm

EXPERIMENTAL

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

Dietary Supplement: glutamine

Placebo arm

PLACEBO COMPARATOR

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

Other: placebo

Interventions

glutamine DIETARY_SUPPLEMENT

Given orally

Glutamine Arm

placebo OTHER

Given orally

Placebo arm

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239-3098, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Glutamine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral

Limitations and Caveats

We were able to only accrue 18 of the 40 patient target. This, plus confounded results and limited funds, the remaining research funds were returned to the sponsor and no evaluation of serum or dietary glutamine levels was done.

Results Point of Contact

• Title: Joseph Bublao
• Organization: OHSU Knight Cancer Institute

bubaloj@ohsu.edu

503-494-1054

Study Officials

• Joseph Bubalo, PharmD, BCPS, BCOP

  OHSU Knight Cancer Institute

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PharmD

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Study Start: July 1, 1999
• Primary Completion: January 1, 2009
• Study Completion: March 1, 2009
• Last Updated: May 9, 2017
• Results First Posted: September 24, 2010

Record last verified: 2017-05

Locations

US (1)