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Sponsored by: |
Banaras Hindu University |
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Information provided by: | Banaras Hindu University |
ClinicalTrials.gov Identifier: | NCT00772824 |
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.
Condition | Intervention | Phase |
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Breast Cancer |
Dietary Supplement: Glutamine Dietary Supplement: IV Glutamine |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment |
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 |
Estimated Enrollment: | 30 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: No Intervention
10 patients (30 cycles) of chemotherapy will receive placebo
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2: Active Comparator
Intravenous glutamine
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Dietary Supplement: IV Glutamine
50 ml of 20% glutamine IV before chemotherapy
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3: Experimental
Oral Glutamine
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Dietary Supplement: Glutamine
2g/kg body weight twice daily in divided doses for 5 days
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Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Manoj Pandey, MS | 915422309511 | manojpandey@vsnl.com |
Contact: Deepika Joshi, MD, DM | 915422307576 | oncosurgery@hotmail.com |
India, UP | |
Sir Sunder Lal Hospital | Recruiting |
Varanasi, UP, India, 221005 | |
Contact: Manoj Pandey, MS 915422309511 manojpandey@vsnl.com | |
Principal Investigator: R K Goel, MD |
Principal Investigator: | R K Goel, MD | Institute of Medical Sciences |
Responsible Party: | Institute of Medical Sciences ( Dr. Manoj Pandey, Head, Surgical Oncology ) |
Study ID Numbers: | GLU_07 |
Study First Received: | October 14, 2008 |
Last Updated: | October 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00772824 |
Health Authority: | India: Director General Health Services (DGHS), New Delhi, |
Breast cancer Chemotherapy Epirubicin |
Glutamine FEC chemotherapy Chemotherapy |
Skin Diseases Breast Neoplasms Epirubicin Breast Diseases |
Neoplasms Neoplasms by Site |