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

Banaras Hindu University

Status and phase: Completed; Phase 4

Conditions: Breast Cancer

Treatments: Dietary Supplement: IV Glutamine; Dietary Supplement: Glutamine

Study type: Interventional

Funder types: Other

Identifiers

NCT00772824

GLU_07

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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23 participants in 3 patient groups

1

No Intervention group

Description:

10 patients (30 cycles) of chemotherapy will receive placebo

2

Active Comparator group

Description:

Intravenous glutamine

Treatment:

Dietary Supplement: IV Glutamine

3

Experimental group

Description:

Oral Glutamine

Treatment:

Dietary Supplement: Glutamine