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Study aim:
Determining the effect of nanocurcumin capsules on mucositis in patients undergoing autologous and allogeneic transplantation
Design:
A placebo-controlled, triple-blind, randomized, phase 3 clinical trial on 110 patients. A block random number table is used for randomization.
Settings and conduct:
Location: The Bone Marrow Transplantation Department of Taleghani Hospital, Tehran. The intervention group will receive 120 mg of nanocurcumin daily and the control group will receive placebo. Patients, outcome assessor and data analyser will be blinded.
Participants/Inclusion and exclusion criteria:
Inclusion:
Age 18 to 70 years.
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
Written informed consent.
Exclusion:
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 for 7 days prior to conditioning.
Stable oral anticoagulant therapy or dual antiplatelet therapy that cannot be adjusted.
AST or ALT > 3 times the ULN, or total bilirubin > 2 times the ULN, or eGFR < 30 mL/min/1.73 m².
Concurrent participation in another interventional trial that directly affects mucositis, sleep, appetite, or supportive care.
Intervention groups:
Intervention group receive 3 capsules daily of nanocurcumin and Control group receive 3 capsules daily of placebo from two days before the start of chemotherapy until the engraftment and resolution of mucositis.
Main outcome variables:
Who mucositis grading scale