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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


Phase 4
18 Years
85 Years
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Outcome Measure:

Reduction in toxicity

Outcome Time Frame:

3 weeks

Safety Issue:

No

Principal Investigator

R K Goel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institute of Medical Sciences

Authority:

India: Ministry of Health

Study ID:

GLU_07

NCT ID:

NCT00772824

Start Date:

December 2007

Completion Date:

December 2009

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Chemotherapy
  • Epirubicin
  • Glutamine
  • FEC chemotherapy
  • Breast Neoplasms

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