search
Back to results

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

Primary Purpose

Pain, Unspecified Adult Solid Tumor, Protocol Specific

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
glutamine
placebo
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain focused on measuring unspecified adult solid tumor, protocol specific, pain

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • OHSU Knight Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Glutamine Arm

Placebo arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 20, 2005
Last Updated
May 7, 2017
Sponsor
OHSU Knight Cancer Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT00217724
Brief Title
Glutamine in Preventing Myalgia and/or Arthralgia in Patients Who Are Receiving Paclitaxel For Cancer
Official Title
A Double-blinded Pilot Study of Glutamine for the Prevention of Paclitaxel-Induced Myalgias and Arthralgias
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Only able to accrue just 18 of the 40 target & funds were limited.
Study Start Date
July 1999 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OHSU Knight Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
unspecified adult solid tumor, protocol specific, pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glutamine Arm
Arm Type
Experimental
Arm Description
Beginning on day 2 of course 1 of paclitaxel administration, patients receive oral glutamine three times daily for 4 days.
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
Beginning on day 2 of course 1 of paclitaxel administration, patients receive oral placebo three times daily for 4 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
glutamine
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Given orally
Primary Outcome Measure Information:
Title
Number of Participants With Response From Glutamine Preventing Paclitaxel Induced Myalgias or Arthralgias After 2 Courses of Chemotherapy
Description
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
Time Frame
2 courses of chemotherapy (6 weeks)
Secondary Outcome Measure Information:
Title
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
Time Frame
Duration of participation on study (up to one year)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Bubalo, PharmD, BCPS, BCOP
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs