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IRCT20110427006318N17 IRCT 2025-07-28 Semnan University of Medical Sciences The Effect of Turmeric on Fatigue, Sleep Quality, and Appetite in Women with Breast Cancer Undergoing Chemotherapy: A Clinical Trial Effect of Curcumin on Fatigue, Sleep Quality, and Appetite in Women with Breast Cancer Undergoing Chemotherapy: A Clinical Trial 2025-08-16 anticipated 10 Recruiting https://irct.ir/trial/85044 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The research sample assigned to the groups of the study by permuted blocks randomization. The samples are randomly divided into two intervention and control groups using blocks of six (the age and disease stage strata are used in the block division). Regarding age, the first patient is randomly placed in the intervention or control group, and the next patient with a maximum age difference of 5 years is placed in the other group. If the age difference between the next patient and the next patient is more than 5 years, the patient is randomly placed in another age block. Randomization is also conducted separately for disease stage. In this manner, the first patient at each disease stage is randomly assigned to either the intervention or control group, and the next patient with the same disease stage is placed in the opposite group, Blinding description: This study is a triple-blind randomized clinical trial. In this study, 500 mg turmeric tablets and placebo tablets are administered by the treating physician to patients in two groups: the intervention group and the control group. Only the treating physician is aware of the group assignments. Consequently, the patients participating in the study, the principal investigator, the questionnaire collector, and the data analyst remain unaware of the group allocations. N/A Women with breast cancer undergoing chemotherapy. Intervention 1: Intervention group: The intervention group will receive one 500 mg turmeric tablet once a day with lunch for one month, in addition to their routine diet. Intervention 2: Control group: The control group will receive one placebo tablet once a day with lunch for one month, also in addition to their routine diet. No - There is not a plan to make this available Justification or reason for not sharing IPD is Data is confidential
public Monir Nobahar
Semnan University of Medical Sciences, Basij Boulevard, Semnan
Semnan Iran (Islamic Republic of) 3513138111 +98 23 3365 4190 nobahar43@yahoo.com Semnan University of Medical Sciences scientific Monir Nobahar
Semnan University of Medical Sciences, Basij Boulevard, Semnan
Semnan Iran (Islamic Republic of) 3513138111 +98 23 3365 4190 nobahar43@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) - Breast cancer diagnosis at least six months or more - Women undergoing chemotherapy - Women over 18 years of age - Sleep quality higher than 5 on the Pittsburgh scale - Informed consent to participate in the study 18 years no limit Female - Discontinuation of Chemotherapy - Intolerance to curcumin or a history of sensitivity to curcumin - Failure to fully participate in the one-month period - Voluntary withdrawal - History of mental disorders - Unstable medical conditions or concomitant diseases - Hospitalization during the study - History of cancer-related surgery - Metastasis to other sites - Death during the study (C50-C50) Malignant neoplasm of breast Treatment - Other Placebo Intervention group: The intervention group will receive one 500 mg turmeric tablet once a day with lunch for one month, in addition to their routine diet. Control group: The control group will receive one placebo tablet once a day with lunch for one month, also in addition to their routine diet Sleep quality. Timepoint: At the beginning of the study and after one month. Method of measurement: Using the Pittsburgh Sleep Quality Index. Fatigue. Timepoint: At the beginning of the study and after one month. Method of measurement: Using the Cancer Fatigue Scale. Appetite. Timepoint: At the beginning of the study and after one month. Method of measurement: Using a Visual Analog Scale. Semnan University of Medical Sciences Approved 2025-07-21 کمیته اخلاق دانشگاه علوم پزشکی سمنان Semnan University of Medical Sciences, Basij Boulevard, Semnan Semnan Semnan Iran (Islamic Republic of)