Evaluating the Effectiveness of Nanocurcumin Capsules on oral ulcer in Patients Undergoing Hematopoietic Stem Cell Transplantation: A Randomized Triple-blind Placebo controlled Clinical trial

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2026
INTERVENTION: 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 company, from two days before the start of chemotherapy until the engraftment and resolution of mucositis. Intervention 2: Control group: Receive 3 capsules daily (one after each meal) of placebo, from two days before the start of chemotherapy until the engraftment and resolution of mucositis. CONDITION: Patients with various Blood Malignancies who are candidates for Hematopoietic Stem Cell Transplantation.. ; Complications of bone marrow transplant T86.0 PRIMARY OUTCOME: 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. 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. SECONDARY OUTCOME: Determining the effect of nanocurcumin on days of neutropenic fever in patients undergoing autologous and allogeneic transplantation. Timepoint: From the onset of intervention until resolution of mucositis and engraftment of patients. Method of measurement: Measurement of body temperature of patients during neutropenic period. 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 Inde X(PSQI). 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 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 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 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: Duration of need for total parenteral nutrition in patients. 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 safety and side effects of nanocurcumin in patients undergoing autologous and allogeneic transplantation. Timepoint: Weekly from the onset of intervention until resolution of mucositis and engraftment of patients. Method of measurement: Questionnaire based on common adverse effect of nanocurcumin based on studies.
Epistemonikos ID: 067878b66d2ea0f91127c36af4b2bde970096882
First added on: Aug 08, 2026