Patients with various Blood Malignancies who are candidates for Hematopoietic Stem Cell Transplantation.. Complications of bone marrow transplant
Conditions
Interventions
Intervention 1: Intervention group: Receive 3 capsules daily (one after each meal) of nanocurcumin containing 40 mg of curcuminoids in a highly bioavailable nanomicelle medium from Exir Nano Sina comp
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Age 18 to 70 years. Confirmation of HSCT candidacy by the transplant team. Adequate performance status, i.e. Eastern Cooperative Oncology Group (ECOG) score from 0 to 2. Ability to swallow and take capsules orally at the time of intervention and the possibility of taking them for at least one week after conditioning. Patients’ agreement to standard mucositis prevention care according to the center’s protocol (prevention: chlorhexidine and normal saline mouthwash, treatment: diphenhydramine + AlMg + nystatin + lidocaine cocktail and, if needed and available, gelclair mouthwash and mucosamine spray). Written informed consent.
Exclusion criteria
Exclusion criteria: Known hypersensitivity to Curcumin, Turmeric, or components of the nanomicelle product. Chronic systemic corticosteroid use at a dose equivalent to >10 mg prednisone daily for 14 days prior to conditioning. Regular use of supplements or herbs with anti-inflammatory-antioxidant effects or containing Piperine for 7 days prior to conditioning, including high doses of vitamins A-C-E, selenium, non-study turmeric products, ginger, chamomile. Stable oral anticoagulant therapy or dual antiplatelet therapy that cannot be adjusted. Single low-dose aspirin use is acceptable and will be recorded. AST or ALT > 3 times the upper limit of normal, or total bilirubin > 2 times the upper limit of normal, or eGFR < 30 mL/min/1.73 m². Concurrent participation in another interventional trial that directly affects mucositis, sleep, appetite, or supportive care. Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determining the effect of nanocurcumin capsules on mucositis in patients undergoing autologous and allogeneic transplantation. Timepoint: From the onset of mucositis to the resolution of mucositis. Method of measurement: WHO mucositis grading scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Determining the effect of nanocurcumin on the incidence and severity of oral mucositis in patients undergoing autologous and allogeneic transplantation. Timepoint: From the onset to the resolution of mucositis. Method of measurement: WHO mucositis grading scale.;Determining the effect of nanocurcumin on the onset and termination time of oral mucositis in patients undergoing autologous and allogeneic transplantation. Timepoint: From the onset to the resolution of mucositis. Method of measurement: WHO mucositis grading scale.;Determining the effect of nanocurcumin on the host incidence and severity of gastrointestinal mucositis in patients undergoing autologous and allogeneic transplantation. Timepoint: From the onset to the resolution of mucositis. Method of measurement: based on CTCAE v 5.0 criteria.;Determining the effect of nanocurcumin on the appetite of patients undergoing autologous and allogeneic transplantation. Timepoint: Before intervention initiation, during chemotherapy or neutropenic period, after engraftment. Method of measurement: The Council on Nutrition Appetite Questionnaire (CNAQ).;Determining the effect of nanocurcumin on sleep of patients undergoing autologous and allogeneic transplantation. Timepoint: Before intervention initiation, during chemotherapy or neutropenic period, after engraftment. Method of measurement: Pittsburgh Sleep Quality Index (PSQI).;Determining the effect of nanocurcumin on the need for narcotic analgesics in patients undergoing autologous and allogeneic transplantation. Timepoint: From the beginning of intervention until resolution of mucositis and engraftment of patients. Method of measurement: Total morphine equivalent dose of prescribed opioids.;Determining the effect of nanocurcumin on the need for total parenteral nutrition in patients undergoing autologous and allogeneic transplantation. Timepoint: From the beginning of intervention until resolution of mucositis and engraftment of patients. Method of measurement: Dur | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMaria Tavakoli Ardakani
Shahid Beheshti University of Medical Sciences
Outcome results
None listed