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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


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Peripheral Neuropathy, Breast Cancer

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Trial Information

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


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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

effect of glutamine on peripheral neuropathy

Outcome Time Frame:

duration of study

Safety Issue:

No

Principal Investigator

Linda Vahdat, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Weill Medical College of Cornell University

Authority:

United States: Food and Drug Administration

Study ID:

0309006308

NCT ID:

NCT00195013

Start Date:

December 2003

Completion Date:

December 2010

Related Keywords:

  • Peripheral Neuropathy
  • Breast Cancer
  • Breast Neoplasms
  • Peripheral Nervous System Diseases
  • Demyelinating Diseases
  • Polyneuropathies
  • Nerve Compression Syndromes
  • Neurologic Manifestations
  • Neurotoxicity Syndromes

Name

Location

Weill Medical College of Cornell UniversityNew York, New York  10021