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
About this trial
This is an interventional prevention trial for Breast Cancer focused on measuring Breast cancer, Chemotherapy, Epirubicin, Glutamine, FEC chemotherapy
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
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
NCT ID
NCT00772824
First Posted
October 14, 2008
Last Updated
July 14, 2018
Sponsor
Banaras Hindu University
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
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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
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Citation
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Results Reference
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PubMed Identifier
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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
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Citation
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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
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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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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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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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