Oral Mucositis (Ulcerative) Clinical Trial
Official title:
Phase III Randomized, Double Blind, Placebo Controlled Study of Curcumin to Reduce Mucositis in Autologous Transplant Setting
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.
Status | Recruiting |
Enrollment | 190 |
Est. completion date | May 16, 2025 |
Est. primary completion date | May 16, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
India | Tata Memorial Centre | Navi Mumbai | Maharashtra |
Lead Sponsor | Collaborator |
---|---|
Tata Memorial Centre |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of grade 3 and 4 oral mucositis | In both groups, patients will be evaluated clinically for oral mucositis. The incidence of grade III/IV oral mucositis will be recorded as per WHO grading criteria. | Day+28 | |
Secondary | Incidence of any grade of oral mucositis. | In both groups, patients will be evaluated clinically for oral mucositis and grade will be recorded as per WHO grading criteria. | Day+28 | |
Secondary | Duration of grade 3 and 4 oral mucositis in both groups | In both groups, duration of oral mucositis will be recorded. | Day+28 | |
Secondary | Incidence of use of Total Parenteral Nutrition | Incidence of use of Total Parenteral Nutrition in both groups. | Day+28 | |
Secondary | Duration of use of Total Parenteral Nutrition | The duration of use of total parenteral nutrition will be recorded in both groups. | Day+28 | |
Secondary | Serum TNF alpha AUC (0-14) | This will be calculated using serum TNF alpha levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14. Using these values, AUC (0-14) will be calculated using linear trapezoidal model. | Day+14 | |
Secondary | Salivary TNF alpha AUC (0-14) | This will be calculated using Salivary TNF alpha levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14. Using these values, AUC (0-14) will be calculated using linear trapezoidal model. | Day+14 | |
Secondary | Serum Interleukin 1 AUC (0-14) | This will be calculated using Serum Interleukin 1 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14. Using these values, AUC (0-14) will be calculated using linear trapezoidal model. | Day+14 | |
Secondary | Salivary Interleukin 1 AUC (0-14) | This will be calculated using Salivary Interleukin 1 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14. Using these values, AUC (0-14) will be calculated using linear trapezoidal model. | Day+14 | |
Secondary | Serum Interleukin 6 AUC (0-14) | This will be calculated using Serum Interleukin 6 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14. Using these values, AUC (0-14) will be calculated using linear trapezoidal model. | Day+14 | |
Secondary | Salivary Interleukin 6 AUC (0-14) | This will be calculated using Salivary Interleukin 6 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14. Using these values, AUC (0-14) will be calculated using linear trapezoidal model. | Day+14 | |
Secondary | Serum Interleukin 8 AUC (0-14) | This will be calculated using Serum Interleukin 8 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14. Using these values, AUC (0-14) will be calculated using linear trapezoidal model. | Day+14 | |
Secondary | Salivary Interleukin 8 AUC (0-14) | This will be calculated using Salivary Interleukin 8 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14. Using these values, AUC (0-14) will be calculated using linear trapezoidal model. | Day+14 | |
Secondary | Serum Interleukin 17 AUC (0-14) | This will be calculated using Serum Interleukin 17 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14. Using these values, AUC (0-14) will be calculated using linear trapezoidal model. | Day+14 | |
Secondary | Salivary Interleukin 17 AUC (0-14) | This will be calculated using Salivary Interleukin 17 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14. Using these values, AUC (0-14) will be calculated using linear trapezoidal model. | Day+14 | |
Secondary | Serum TGF-beta AUC (0-14) | This will be calculated using Serum TGF-beta levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14. Using these values, AUC (0-14) will be calculated using linear trapezoidal model. | Day+14 | |
Secondary | Salivary TGF-beta AUC (0-14) | This will be calculated using Salivary TGF-beta levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14. Using these values, AUC (0-14) will be calculated using linear trapezoidal model. | Day+14 | |
Secondary | Serum Interferon gamma AUC (0-14) | This will be calculated using Serum Interferon gamma levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14. Using these values, AUC (0-14) will be calculated using linear trapezoidal model. | Day+14 | |
Secondary | Salivary Interferon gamma AUC (0-14) | This will be calculated using Salivary Interferon gamma levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14. Using these values, AUC (0-14) will be calculated using linear trapezoidal model. | Day+14 | |
Secondary | Serum Prostaglandin E2 AUC (0-14) | This will be calculated using Serum Prostaglandin E2 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14. Using these values, AUC (0-14) will be calculated using linear trapezoidal model. | Day+14 | |
Secondary | Salivary Prostaglandin E2 AUC (0-14) | This will be calculated using Salivary Prostaglandin E2 levels measured at baseline, day 0, then Monday, Wednesday and Friday till day +14. Using these values, AUC (0-14) will be calculated using linear trapezoidal model. | Day+14 | |
Secondary | Plasma curcumin AUC (0-12 hr) | This will be done using plasma curcumin levels measured within 1 hr of dosing, 0.5-3 hr, 4-6 hr, and 8 - 12 hr post dose on day 7 of starting curcumin or placebo. | Up to 12 hours from 1st dose | |
Secondary | Plasma Bis-demethoxycurcumin AUC (0-12 hr) | This will be done using plasma Bis-demethoxycurcumin levels measured within 1 hr of dosing, 0.5-3 hr, 4-6 hr, and 8 - 12 hr post dose on day 7 of starting curcumin or placebo. | Up to 12 hours from 1st dose | |
Secondary | Plasma demethoxycurcumin AUC (0-12 hr) | This will be done using plasma demethoxycurcumin levels measured within 1 hr of dosing, 0.5-3 hr, 4-6 hr, and 8 - 12 hr post dose on day 7 of starting curcumin or placebo. | Up to 12 hours from 1st dose | |
Secondary | Duration of use of analgesics for pain due to oral mucositis | Duration of use of analgesics for pain due to oral mucositis in both groups will be recorded.The severity of pain will be measured using the visual analog pain scale. | Day+28 | |
Secondary | Incidence of grade 3 and 4 nausea | In both groups, grade of nausea will be recorded as per CTCAE v 4.0 grading criteria. | Day+28 | |
Secondary | Incidence of grade 3 and 4 vomiting | In both groups, grade of vomiting will be recorded as per CTCAE v 4.0 grading criteria. | Day+28 | |
Secondary | Incidence of grade 3 and 4 diarrhea | In both groups, grade of diarrhea will be recorded as per CTCAE v 4.0 grading criteria. | Day+28 | |
Secondary | Duration of hospital stay | The duration of hospital stay will be recorded in both groups. | From date of hospital admission until date of hospital discharge assessed up to day +28 |
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