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

Phase 4

Completed

• Conditions: Breast Cancer
• Interventions: Dietary Supplement: IV Glutamine; Dietary Supplement: Glutamine

• Registration Number: NCT00772824
• Lead Sponsor: Banaras Hindu University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-10-14
• Study First Submitted QC: 2008-10-14
• Study First Posted: 2008-10-15
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-14
• Last Update Posted: 2018-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 23

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	IV Glutamine	Intravenous glutamine
3	Glutamine	Oral Glutamine

Primary Outcome Measures

Name	Time	Method
Reduction in toxicity	3 weeks

Secondary Outcome Measures

Name	Time	Method
Serum level of creatinine kinase and LDH	3 weeks

Trial Locations

Locations (1)

Sir Sunder Lal Hospital; 🇮🇳 Varanasi, UP, India