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Completed

NCT Number: NCT00772824

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

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Sir Sunder Lal Hospital

Varanasi, Uttar Pradesh, 221005, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glutamine

Dietary Supplement

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

IV Glutamine

Dietary Supplement

50 ml of 20% glutamine IV before chemotherapy

Primary outcomes

  1. Reduction in toxicity

    Time frame: 3 weeks

Secondary outcomes

  1. Serum level of creatinine kinase and LDH

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

Banaras Hindu University

Other

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 15, 2008
Registry last updated
Jul 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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