CTRI/2018/01/011418
Completed
Phase 3
Phase 3 randomised controlled trial comparing the effectiveness of restricting raw fruits from the diet of patients undergoing induction chemotherapy for acute leukemia
Cancer Institute0 sites200 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]Health Condition 2: C920- Acute myeloblastic leukemiaHealth Condition 3: null- Patients with acute lymphoblastic leukemia or acute myeloid leukemia
- Sponsor
- Cancer Institute
- Enrollment
- 200
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients 1 year to 60 years of age
- •2\. Diagnosed with either acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL)
- •3\. Patient should be able to consume normal diet orally
- •4\. No evidence of infection at the time of randomization (clinically, radiologically or microbiologically)
- •5\. In case of age less than 18 years, parent/guardian (legally authorized representative) agrees to the patientâ??s participation as indicated by parent/legal guardian signature on the informed consent form.
- •6\. Signed informed consent in patients more than 18 years of age
- •7\. Patient is scheduled to receive induction chemotherapy for ALL or AML as per the protocol with curative intent.
- •8\. Patient \>10 years of age has a Karnofsky score \>\=60; patient \<\=10 years of age has a Lansky Play Performance score \>\=60\.
Exclusion Criteria
- •1\. Patient is pregnant or breast feeding. (Females of child bearing potential are required to have a negative urine pregnancy test prior to entering the study).
- •2\. Patients with relapsed leukemia.
- •3\. SGOT (AST) \> 5\.0 x upper limit of normal (ULN) and SGPT (ALT) \>5\.0 x ULN and Bilirubin \>1\.5 x ULN.
- •4\. Serum creatinine \> ULN.
- •5\. Patient has an active infection (e.g., pneumonia, diarrhoea, urinary tract infection, cellulitis, meningitis, otitis media and sinusistis).
- •6\.Congestive heart failure, bradyarrythmia, ischemic heart disease, uncontrolled diabetes mellitus or hypertension.
- •7\.Gastrointestinal obstruction, malabsorption syndrome or persistent vomiting.
- •8\.Patient is mentally incapacitated or has a significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry.
- •9\. Palliative intent of treatment or planned reduction in intensity of treatment due to co\-morbidities or poor performance status.
Outcomes
Primary Outcomes
Not specified
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