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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Banaras Hindu University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Banaras Hindu University
ClinicalTrials.gov Identifier:
NCT00772824
First received: October 14, 2008
Last updated: August 10, 2009
Last verified: August 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
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

Resource links provided by NLM:


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
No Intervention: 1
10 patients (30 cycles) of chemotherapy will receive placebo
Active Comparator: 2
Intravenous glutamine
Dietary Supplement: IV Glutamine
50 ml of 20% glutamine IV before chemotherapy
Experimental: 3
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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:

Responsible Party: Dr. Manoj Pandey, Head, Surgical Oncology, Institute of Medical Sciences
ClinicalTrials.gov Identifier: NCT00772824     History of Changes
Other Study ID Numbers: GLU_07
Study First Received: October 14, 2008
Last Updated: August 10, 2009
Health Authority: India: Ministry of Health

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 31, 2014