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Study of the Effect of Glutamine Supplementation on Chemotherapy Induced Toxicities in Breast Cancer Patients
This study is currently recruiting participants.
Verified by Banaras Hindu University, October 2008
Sponsored by: Banaras Hindu University
Information provided by: Banaras Hindu University
ClinicalTrials.gov Identifier: NCT00772824
  Purpose

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
Breast Cancer
Dietary Supplement: Glutamine
Dietary Supplement: IV Glutamine
Phase IV

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Dietary Supplements
Drug Information available for: Epirubicin hydrochloride Epirubicin Glutamine
U.S. FDA Resources
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

Further study details as provided by Banaras Hindu University:

Primary Outcome Measures:
  • Reduction in toxicity [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum level of creatinine kinase and LDH [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

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
1: No Intervention
10 patients (30 cycles) of chemotherapy will receive placebo
2: Active Comparator
Intravenous glutamine
Dietary Supplement: IV Glutamine
50 ml of 20% glutamine IV before chemotherapy
3: Experimental
Oral Glutamine
Dietary Supplement: Glutamine
2g/kg body weight twice daily in divided doses for 5 days

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00772824

Contacts
Contact: Manoj Pandey, MS 915422309511 manojpandey@vsnl.com
Contact: Deepika Joshi, MD, DM 915422307576 oncosurgery@hotmail.com

Locations
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            
Sponsors and Collaborators
Banaras Hindu University
Investigators
Principal Investigator: R K Goel, MD Institute of Medical Sciences
  More Information

Publications:
Bergström J, Fürst P, Norée LO, Vinnars E. Intracellular free amino acid concentration in human muscle tissue. J Appl Physiol. 1974 Jun;36(6):693-7. No abstract available.
Lacey JM, Wilmore DW. Is glutamine a conditionally essential amino acid? Nutr Rev. 1990 Aug;48(8):297-309. Review.
Daniele B, Perrone F, Gallo C, Pignata S, De Martino S, De Vivo R, Barletta E, Tambaro R, Abbiati R, D'Agostino L. Oral glutamine in the prevention of fluorouracil induced intestinal toxicity: a double blind, placebo controlled, randomised trial. Gut. 2001 Jan;48(1):28-33.
Rubio IT, Cao Y, Hutchins LF, Westbrook KC, Klimberg VS. Effect of glutamine on methotrexate efficacy and toxicity. Ann Surg. 1998 May;227(5):772-8; discussion 778-80.
Satoh J, Tsujikawa T, Fujiyama Y, Bamba T. Nutritional benefits of enteral alanyl-glutamine supplementation on rat small intestinal damage induced by cyclophosphamide. J Gastroenterol Hepatol. 2003 Jun;18(6):719-25.
van der Hulst RR, van Kreel BK, von Meyenfeldt MF, Brummer RJ, Arends JW, Deutz NE, Soeters PB. Glutamine and the preservation of gut integrity. Lancet. 1993 May 29;341(8857):1363-5.
Govindarajan R, Heaton KM, Broadwater R, Zeitlin A, Lang NP, Hauer-Jensen M. Effect of thalidomide on gastrointestinal toxic effects of irinotecan. Lancet. 2000 Aug 12;356(9229):566-7.
Berthrong M. Pathologic changes secondary to radiation. World J Surg. 1986 Apr;10(2):155-70. No abstract available.
Huang EY, Leung SW, Wang CJ, Chen HC, Sun LM, Fang FM, Yeh SA, Hsu HC, Hsiung CY. Oral glutamine to alleviate radiation-induced oral mucositis: a pilot randomized trial. Int J Radiat Oncol Biol Phys. 2000 Feb 1;46(3):535-9.
Cao Y, Kennedy R, Klimberg VS. Glutamine protects against doxorubicin-induced cardiotoxicity. J Surg Res. 1999 Jul;85(1):178-82.
Boyle FM, Wheeler HR, Shenfield GM. Amelioration of experimental cisplatin and paclitaxel neuropathy with glutamate. J Neurooncol. 1999 Jan;41(2):107-16.
Vahdat L, Papadopoulos K, Lange D, Leuin S, Kaufman E, Donovan D, Frederick D, Bagiella E, Tiersten A, Nichols G, Garrett T, Savage D, Antman K, Hesdorffer CS, Balmaceda C. Reduction of paclitaxel-induced peripheral neuropathy with glutamine. Clin Cancer Res. 2001 May;7(5):1192-7.

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,

Keywords provided by Banaras Hindu University:
Breast cancer
Chemotherapy
Epirubicin
Glutamine
FEC chemotherapy
Chemotherapy

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Epirubicin
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009