Study to find out if restricting raw fruits in patients with blood cancer can reduce infections.
- 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
- Registration Number
- CTRI/2018/01/011418
- Lead Sponsor
- Cancer Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the incidence of infectious episodes and fever between the restricted diet and regular diet group.Timepoint: Patients will be censored in the trial at the following instances <br/ ><br>1.Completion of induction chemotherapy and discharge from hospital or day 40 of induction chemotherapy, whichever is earlier. <br/ ><br>2.Death occurring within 40 days of starting induction chemotherapy. <br/ ><br>3.Patient withdraws from the trial. <br/ ><br>
- Secondary Outcome Measures
Name Time Method To assess the prevalence of multi drug resistance (MDR) bacteria in stool culture at admission and on day 15 of induction and correlate with blood culture positivity. To assess the impact of restricted diet vs regular diet on stool microbial flora in patients undergoing induction chemotherapy for acute leukemia. <br/ ><br>Timepoint: Patients will be censored in the trial at the following instances <br/ ><br>1.Completion of induction chemotherapy and discharge from hospital or day 40 of induction chemotherapy, whichever is earlier. <br/ ><br>2.Death occurring within 40 days of starting induction chemotherapy. <br/ ><br>3.Patient withdraws from the trial. <br/ ><br>