Effect of Curcumin on Fatigue, Sleep Quality, and Appetite in Women with Breast Cancer Undergoing Chemotherapy: A Clinical Trial

To determine the effect of curcumin on fatigue, sleep quality, and appetite in women with breast cancer undergoing chemotherapy

Clinical Trial, by using block randomization, the Patients enter in intervention, or control group, A pilot study including10 patients from each group, will determine the size of the sample, Parallel groups, triple-blind

This study is a triple-blind clinical trial conducted at Kowsar Hospital in Semnan.

Inclusion criteria: 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. Exclusion criteria:Discontinuation of chemotherapy, Intolerance to curcumin or 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.

The intervention group received 500 mg of Curcumin Longa tablets once a day with lunch for one month, in addition to their routine regimen. The control group received a placebo tablet once a day with lunch for one month, also in addition to their routine regimen.

Sleep quality, fatigue, and appetite

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.

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.

Data is confidential