Breast Cancer
Conditions
Keywords
Breast cancer, Chemotherapy, Epirubicin, Glutamine, FEC chemotherapy
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTGlutamine
2g/kg body weight twice daily in divided doses for 5 days
DIETARY_SUPPLEMENTIV Glutamine
50 ml of 20% glutamine IV before chemotherapy
Sponsors
Banaras Hindu University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
Case Control
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in toxicity | 3 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Serum level of creatinine kinase and LDH | 3 weeks |
Countries
India
Outcome results
None listed