- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00217724
Glutamine in Preventing Myalgia and/or Arthralgia in Patients Who Are Receiving Paclitaxel For Cancer
A Double-blinded Pilot Study of Glutamine for the Prevention of Paclitaxel-Induced Myalgias and Arthralgias
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239-3098
- OHSU Knight Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Glutamine Arm
Beginning on day 2 of course 1 of paclitaxel administration, patients receive oral glutamine three times daily for 4 days.
|
Given orally
|
Placebo Comparator: Placebo arm
Beginning on day 2 of course 1 of paclitaxel administration, patients receive oral placebo three times daily for 4 days.
|
Given orally
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Response From Glutamine Preventing Paclitaxel Induced Myalgias or Arthralgias After 2 Courses of Chemotherapy
Time Frame: 2 courses of chemotherapy (6 weeks)
|
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 Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
|
Duration of participation on study (up to one year)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Joseph Bubalo, PharmD, BCPS, BCOP, OHSU Knight Cancer Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000446073
- OHSU-ONC-99037-L (Other Identifier: OHSU Knight Cancer Institute)
- 1252 (OHSU IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Cairo UniversityCompletedCervical Pain | Lumbar Pain SyndromeEgypt
Clinical Trials on placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States