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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Glutamine
IV Glutamine
Sponsored by
Banaras Hindu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Breast cancer, Chemotherapy, Epirubicin, Glutamine, FEC chemotherapy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Sir Sunder Lal Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

1

2

3

Arm Description

10 patients (30 cycles) of chemotherapy will receive placebo

Intravenous glutamine

Oral Glutamine

Outcomes

Primary Outcome Measures

Reduction in toxicity

Secondary Outcome Measures

Serum level of creatinine kinase and LDH

Full Information

First Posted
October 14, 2008
Last Updated
July 14, 2018
Sponsor
Banaras Hindu University
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1. Study Identification

Unique Protocol Identification Number
NCT00772824
Brief Title
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

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Banaras Hindu University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, Chemotherapy, Epirubicin, Glutamine, FEC chemotherapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Case Control
Masking
Participant
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
10 patients (30 cycles) of chemotherapy will receive placebo
Arm Title
2
Arm Type
Active Comparator
Arm Description
Intravenous glutamine
Arm Title
3
Arm Type
Experimental
Arm Description
Oral Glutamine
Intervention Type
Dietary Supplement
Intervention Name(s)
Glutamine
Intervention Description
2g/kg body weight twice daily in divided doses for 5 days
Intervention Type
Dietary Supplement
Intervention Name(s)
IV Glutamine
Intervention Description
50 ml of 20% glutamine IV before chemotherapy
Primary Outcome Measure Information:
Title
Reduction in toxicity
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Serum level of creatinine kinase and LDH
Time Frame
3 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R K Goel, MD
Organizational Affiliation
Institute of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sir Sunder Lal Hospital
City
Varanasi
State/Province
UP
ZIP/Postal Code
221005
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
4829908
Citation
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.
Results Reference
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PubMed Identifier
2080048
Citation
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.
Results Reference
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PubMed Identifier
11115819
Citation
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.
Results Reference
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PubMed Identifier
9605669
Citation
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.
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PubMed Identifier
12753156
Citation
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.
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PubMed Identifier
8098788
Citation
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.
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PubMed Identifier
10950238
Citation
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.
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Citation
Berthrong M. Pathologic changes secondary to radiation. World J Surg. 1986 Apr;10(2):155-70. doi: 10.1007/BF01658133. No abstract available.
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PubMed Identifier
10701731
Citation
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.
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PubMed Identifier
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Citation
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.
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PubMed Identifier
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Citation
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.
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Citation
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Results Reference
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Study of the Effect of Glutamine Supplementation on Chemotherapy Induced Toxicities in Breast Cancer Patients

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