Using curcumin to reduce mouth sores in stem cell transplant patients
Phase III Randomized, Double Blind, Placebo Controlled Study of Curcumin to Reduce Mucositis in Autologous Transplant Setting
PHASE3 · Tata Memorial Centre · NCT04896164
This study is testing if curcumin lozenges can help reduce painful mouth sores in patients getting stem cell transplants.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 190 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tata Memorial Centre (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Navi Mumbai, Maharashtra) |
| Trial ID | NCT04896164 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of curcumin lozenges in reducing the incidence and duration of oral mucositis in patients undergoing autologous stem cell transplantation. Mucositis is a common and painful complication resulting from high-dose chemotherapy, affecting up to 90% of patients. The study aims to lower the levels of pro-inflammatory cytokines associated with mucositis through the anti-inflammatory properties of curcumin. Participants will be randomly assigned to receive either curcumin or placebo lozenges during their treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are undergoing high-dose chemotherapy for autologous stem cell transplantation.
Not a fit: Patients currently on NSAIDs, aspirin, antioxidants, or systemic steroids may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, low-toxicity option for preventing painful mouth sores in patients undergoing stem cell transplants.
How similar studies have performed: Previous studies have shown some success with other interventions for mucositis, but this approach using curcumin is novel.
Eligibility criteria
Show full inclusion / exclusion 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 for autologous transplant in any indicated malignant disease. 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) lesser 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.
Where this trial is running
Navi Mumbai, Maharashtra
- Tata Memorial Centre — Navi Mumbai, Maharashtra, India (RECRUITING)
Study contacts
- Principal investigator: Navin Khattry, MD, DM — Tata Memorial Centre Advanced Centre for Treatment, Research and Education in Cancer
- Study coordinator: Navin Khattry, MD, DM
- Email: nkhattry@gmail.com
- Phone: 022-27405000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Oral Mucositis, Curcumin, Mucositis, Autologous stem cell transplant