Preventing fever in neutropenic children with cancer who are receiving chemotherapy by probiotic supplementatio
Phase 3
- Conditions
- Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]Health Condition 2: C920- Acute myeloblastic leukemiaHealth Condition 3: C419- Malignant neoplasm of bone and articular cartilage, unspecifiedHealth Condition 4: C499- Malignant neoplasm of connective and soft tissue, unspecifiedHealth Condition 5: C692- Malignant neoplasm of retinaHealth Condition 6: C859- Non-Hodgkin lymphoma, unspecifiedHealth Condition 7: C7A8- Other malignant neuroendocrine tumors
- Registration Number
- CTRI/2022/03/041187
- Lead Sponsor
- Kritika Setlur
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
To be started on chemotherapy with expected >20% febrile neutropenia incidence or classified as highly myelosuppressive:
a.ALL HR induction
b.AML induction
c.Soft tissue sarcomas
d.NACT or Augmented chemotherapy for Retinoblastoma
e.High risk Neuroblastoma
f.Ewing’s Sarcoma
g.Osteosarcoma
Exclusion Criteria
1.Patients having received prior chemotherapy
2.Patients having coexisting GIT pathologies at presentation (e.g. Malabsorption, intestinal obstruction)
3.Patients documented to have taken probiotics in the past 6 months duration
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients developed febrile neutropenia, as defined as fever more than 100F two episodes 1 hour apart or one episode of fever more than 101F with ANC of less than 500, in probiotic and placebo armsTimepoint: Assessment at the end of drug administration period, i.e, just prior to administration of second protocol/cycle of chemotherapy: Day 30 for leukemias, Day 20 for solid tumors
- Secondary Outcome Measures
Name Time Method