Status:
UNKNOWN
Randomized Trial of Curcumin to Reduce Mucositis in Autologous Transplant Setting
Lead Sponsor:
Tata Memorial Centre
Conditions:
Oral Mucositis (Ulcerative)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Mucositis is a very common complication in bone marrow transplant setting. It is a result of injury to the gut caused by high dose chemotherapy. Currently there are no universal protocols that have be...
Detailed Description
Mucositis is an inevitable side-effect of intensive conditioning therapy used for hematopoietic stem cell transplantation and affects the quality of life of patients undergoing transplant. The inciden...
Eligibility Criteria
Inclusion
- Male or female patients 18 years and above.
- Patients who give written informed consent
- Patients with performance status - 0,1 or 2 (ECOG scale)
- Patients receiving any of the following high dose chemotherapy regimens for autologous transplant in any indicated malignant disease.
- Melphalan- 200 mg/m2 or more (MEL-200 mg/m2)
- Busulfan and Melphalan (BuMEL)
- Carmustine (BCNU), Etoposide, Cytosine Arabinoside and Melphalan ( BEAM)
- Patients who have creatinine clearance \> 50 ml/min
- Patients with serum bilirubin levels \< 2mg/dl. and serum liver enzymes (ALT or AST or both) lesser than 5 times the upper limit of normal value.
Exclusion
- Patients who are on NSAIDs, aspirin, antioxidants or systemic steroids for more than 3 months and the last dose taken within the last one week.
- Patients being treated for active infection at the time of starting high dose chemotherapy.
Key Trial Info
Start Date :
December 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 16 2025
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT04896164
Start Date
December 16 2018
End Date
May 16 2025
Last Update
November 24 2023
Active Locations (1)
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1
Tata Memorial Centre
Navi Mumbai, Maharashtra, India, 410210