Ability of Curcumin to Decrease Cytokines Involved in Mucositis in the Autologous Transplant

• Status: Completed
• Trial end date: 2015-07-03
• Target enrollment: 0
• Participant gender: All

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 been accepted as a standard to prevent and treat mucositis in the transplant setting. Post transplant upto 80% of patients suffer from a severe mucositis. Proinflammatory cytokines play a major role in the development of mucositis. Interventions that decrease the levels of these cytokines may be beneficial in preventing mucositis. This study is aimed at evaluating the role of curcumin in reducing cytokine levels and the incidence and duration of mucositis in patients undergoing autologous stem cell transplantation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tata Memorial Centre
• Treatments: Curcumin

Criteria

Inclusion Criteria:

1. Male or female patients 18 years and above .

2. Patients who give written informed consent

3. Patients with performance status - 0,1 or 2(ECOG scale)

4. Patients receiving any of the following high dose chemotherapy regimens

1. Melphalan- 200 mg/m2 or more (MEL-200 mg/m2)

2. Busulfan and Melphalan (BuMEL)

3. Carmustine (BCNU), Etoposide, Cytosine Arabinoside and Melphalan ( BEAM)

5. Patients who have creatinine clearance > 50 ml/min

6. Patients with serum bilirubin levels < 2mg/dl. and serum liver enzymes (ALT or AST or both) greater than 5 times the upper limit of normal value.

Exclusion Criteria:

1. 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.

2. Patients being treated for active infection at the time of starting high dose chemotherapy