Clinical trial NCT00772824: Study of the Effect of Glutamine Supplementation on Chemotherapy Induced Toxicities in Breast Cancer Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Keywords: Breast cancer
Chemotherapy
Epirubicin
Glutamine
FEC chemotherapy
Lead sponsor: Banaras Hindu University
Sponsor class: OTHER
First posted: 2008-10-15
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Case Control
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Reduction in toxicity
timeFrame: 3 weeks
Secondary outcomes:
measure: Serum level of creatinine kinase and LDH
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Varanasi
country: India
facility: Sir Sunder Lal Hospital
state: UP
Study officials:
affiliation: Institute of Medical Sciences
name: R K Goel, MD
role: PRINCIPAL_INVESTIGATOR
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