Trial record 10 of 1491 for:    Peripheral Neuropathy

Randomized Placebo-Controlled Trial of Glutamine for Breast Cancer Patients With Peripheral Neuropathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Weill Medical College of Cornell University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00195013
First received: September 14, 2005
Last updated: October 27, 2010
Last verified: October 2010
  Purpose

Patients with breast cancer receiving paclitaxel chemotherapy who have mild symptoms of peripheral neuropathy will receive glutamine or placebo to try and improve symptoms.


Condition Intervention Phase
Peripheral Neuropathy
Breast Cancer
Drug: glutamine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Placebo-controlled Trial of Glutamine to Reduce the Signs and Symptoms of Peripheral Neuropathy in Breast Cancer Patients With a Mild Peripheral Neuropathy Receiving Paclitaxel Chemotherapy

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • effect of glutamine on peripheral neuropathy [ Time Frame: duration of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2003
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: glutamine
    10 grams three times a day (orally) for four days and then stop
    Drug: Placebo
    10 grams three times a day (orally) for four days and then stop
Detailed Description:
  1. Determine whether oral glutamine supplementation can reduce the symptoms and signs of peripheral neuropathy.
  2. Determine whether alterations in the symptoms and signs of peripheral neuropathy are correlated with an alteration of circulating nerve growth factor or insulin-like growth factor levels.
  3. Assess whether oral glutamine affects circulating nerve growth factor or insulin-like growth factor levels.
  4. Assess whether glutamine interferes with paclitaxel pharmacokinetics
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have histologically or cytologically confirmed breast cancer, Stage I, II, III or IV or other solid tumors.
  2. Patients must be receiving weekly paclitaxel or nab-paclitaxel chemotherapy or have recently completed paclitaxel or nab-paclitaxel chemotherapy and have at least a Grade I peripheral neuropathy (see Appendix A) because of therapy.
  3. Because no dosing or adverse event data are currently available on the use of glutamine in patients <18 years of age, children are excluded from this study but will be eligible for future pediatric phase 1 single-agent trials.
  4. ECOG performance status <1 (Karnofsky >90%).
  5. Life expectancy of greater than 3 months.
  6. Patients must have sufficient organ and marrow function so that paclitaxel treatment can be administered.
  7. The effects of glutamine on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  8. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  1. Patients who have experienced prior neuropathies not associated with chemotherapy
  2. Patients may not be receiving any other investigational agents.
  3. Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  4. There are no known allergies associated with glutamine.
  5. Uncontrolled intercurrent illness that render the patient ineligible to receive paclitaxel chemotherapy.
  6. Pregnant women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with glutamine. Breastfeeding should also be discontinued if the mother is treated with glutamine.
  7. Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with glutamine. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.
  8. Concurrent chemotherapy with another drug known to cause neuropathy (CDDP or CBDCA or oxaliplatin) are excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00195013

Contacts
Contact: Linda Vahdat, MD 212-821-0644 ltv2001@med.cornell.edu

Locations
United States, New York
Weill Medical College of Cornell University Recruiting
New York, New York, United States, 10021
Contact: Linda Vahdat       ltv2001@med.cornell.edu   
Principal Investigator: Linda Vahdat, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Linda Vahdat, MD Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Dr. Linda Vahdat, Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT00195013     History of Changes
Other Study ID Numbers: 0309006308
Study First Received: September 14, 2005
Last Updated: October 27, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Breast Neoplasms
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neuromuscular Diseases
Nervous System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on July 22, 2014