Study of the Effect of Glutamine Supplementation on Chemotherapy Induced Toxicities in Breast Cancer Patients

Study Overview
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Brief Summary
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Glutamine, a non essential branched chain amino acid, is most important non toxic nitrogen carrier in body. It participates in variety of physiological functions. It is a major fuel source of enterocytes and is a substrate for gluconeogenesis in kidney, lymphocytes, and monocytes. It is also a nutrient in muscle protein metabolism in response to infection, inflammation and muscle trauma. The significance of glutamine to metabolic homeostasis becomes evident during periods of stress, when it becomes a conditionally essential amino acid. Role of glutamine as protective agent in hepato-biliary dysfunction, in maintaining mucosal integrity of the Gastrointestinal tract following its administration in patient with major bowel surgery as a supplement and part of TPN in critically ill patients and in patients of septicemia, is well established. However the role of glutamine supplementation in reducing or preventing chemotherapeutic agents induced toxicity in cancer patients is controversial.

Official Title
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Study of the Effect of Glutamine Supplementation on Chemotherapy Induced Toxicities in Breast Cancer Patients- A Prospective, Randomised, Single Blind, Three Arm, Phase Four Prevention Trial

Conditions
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Breast Cancer

Intervention / Treatment
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* Dietary Supplement: Glutamine
* Dietary Supplement: IV Glutamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients > 18 years of age Histologically or cytologically proven breast cancer Receiving CEF chemotherapy cycles presently or in the past The patients who will give informed consent to participate in the study Patients must have sufficient organ and marrow function Stage 1 neuropathy, subclinical neuropathy, surgery induced neuropathy Exclusion Criteria: Pregnancy Clinical/biochemical severe liver failure Clinical/biochemical severe renal dysfunction Refusal to participate in the study Patients who have received prior chemotherapy with paclitaxel. Patients who have neuropathy due to any known systemic or metabolic causes like diabetes, leprosy, nutritional deficiency induced (vit. B12) etc

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Case Control
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>10 patients (30 cycles) of chemotherapy will receive placebo | |
| Active Comparator: 2<br>Intravenous glutamine | Dietary Supplement: IV Glutamine<br>* 50 ml of 20% glutamine IV before chemotherapy<br>|
| Experimental: 3<br>Oral Glutamine | Dietary Supplement: Glutamine<br>* 2g/kg body weight twice daily in divided doses for 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in toxicity |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum level of creatinine kinase and LDH |  | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Chemotherapy, Epirubicin, Glutamine, FEC chemotherapy