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

NCT00772824 | Completed Phase 4

• 1 other identifier: GLU_07
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast cancer; Chemotherapy; Epirubicin; Glutamine; FEC chemotherapy

Outcome Measures

Primary Outcomes (1)

• Reduction in toxicity

  3 weeks

Secondary Outcomes (1)

• Serum level of creatinine kinase and LDH

  3 weeks

Study Arms (3)

1

NO INTERVENTION

10 patients (30 cycles) of chemotherapy will receive placebo

2

ACTIVE COMPARATOR

Intravenous glutamine

Dietary Supplement: IV Glutamine

3

EXPERIMENTAL

Oral Glutamine

Dietary Supplement: Glutamine

Interventions

Glutamine DIETARY_SUPPLEMENT

2g/kg body weight twice daily in divided doses for 5 days

3

IV Glutamine DIETARY_SUPPLEMENT

50 ml of 20% glutamine IV before chemotherapy

2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Banaras Hindu University: lead

Study Sites (1)

Sir Sunder Lal Hospital

Varanasi, Uttar Pradesh, 221005, India

Location

Related Publications (12)

• Bergstrom J, Furst P, Noree LO, Vinnars E. Intracellular free amino acid concentration in human muscle tissue. J Appl Physiol. 1974 Jun;36(6):693-7. doi: 10.1152/jappl.1974.36.6.693. No abstract available.

  PMID: 4829908 BACKGROUND

• Lacey JM, Wilmore DW. Is glutamine a conditionally essential amino acid? Nutr Rev. 1990 Aug;48(8):297-309. doi: 10.1111/j.1753-4887.1990.tb02967.x.

  PMID: 2080048 BACKGROUND

• 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. doi: 10.1136/gut.48.1.28.

  PMID: 11115819 BACKGROUND

• 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. doi: 10.1097/00000658-199805000-00018.

  PMID: 9605669 BACKGROUND

• 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. doi: 10.1046/j.1440-1746.2003.03042.x.

  PMID: 12753156 BACKGROUND

• 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. doi: 10.1016/0140-6736(93)90939-e.

  PMID: 8098788 BACKGROUND

• 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. doi: 10.1016/s0140-6736(00)02586-1.

  PMID: 10950238 BACKGROUND

• Berthrong M. Pathologic changes secondary to radiation. World J Surg. 1986 Apr;10(2):155-70. doi: 10.1007/BF01658133. No abstract available.

  PMID: 3705602 BACKGROUND

• 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. doi: 10.1016/s0360-3016(99)00402-2.

  PMID: 10701731 BACKGROUND

• Cao Y, Kennedy R, Klimberg VS. Glutamine protects against doxorubicin-induced cardiotoxicity. J Surg Res. 1999 Jul;85(1):178-82. doi: 10.1006/jsre.1999.5677.

  PMID: 10383856 BACKGROUND

• Boyle FM, Wheeler HR, Shenfield GM. Amelioration of experimental cisplatin and paclitaxel neuropathy with glutamate. J Neurooncol. 1999 Jan;41(2):107-16. doi: 10.1023/a:1006124917643.

  PMID: 10222430 BACKGROUND

• 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.

  PMID: 11350883 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Glutamine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral

Study Officials

• R K Goel, MD

  Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Surgical Oncology

Model Details: Case Control

Study Record Dates

• First Submitted: October 14, 2008
• First Posted: October 15, 2008
• Study Start: December 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 17, 2018

Record last verified: 2018-07

Locations

IN (1)