CTRI/2018/01/011418CompletedPhase 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 enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
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.
Investigators
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