Randomized Placebo-Controlled Trial of Glutamine for Breast Cancer Patients With Peripheral Neuropathy
Condition: Peripheral Neuropathy; Breast Cancer
MeSH terms: Breast Neoplasms; Peripheral Nervous System Diseases
Intervention: glutamine; Placebo
Intervention description: 10 grams three times a day (orally) for four days and then stop; 10 grams three times a day (orally) for four days and then stop
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

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

Eligibility 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.