Moxibustion for gastrointestinal cancer-related fatigue: study protocol for a randomized clinical trial

Cancer-Related Fatigue (CRF) is one of the most prominent subjective symptoms that cancer patients encounter, in particular individuals with gastrointestinal tumors. This fatigue significantly impacts their quality of life, impairs adherence to treatment, and may ultimately reduce overall survival rates. Moxibustion has gradually gained recognition as a therapeutic intervention for CRF. However, clinical evidence supporting the efficacy of moxibustion remains limited.

This investigation employs a randomized, controlled, single-blinded trial design. A 1:1 random allocation method will be implemented to assign 74 participants to either the moxibustion group or the placebo moxibustion group. All participants will undergo eight sessions over 4 weeks, with sessions occurring twice weekly and lasting for 30 minutes each. Assessments for follow-up will take place at week 8. The primary outcome will be the percentage of patients who show a decrease of at least three points on the Brief Fatigue Inventory (BFI) at week 4. Secondary outcomes will encompass changes in the BFI, Quality of Life Questionnaire-Core 30 (QLQ-C30), Generalized Anxiety Disorder Scale-7 (GAD-7). Meanwhile, Blood cell counts and serum T lymphocyte subsets (CD3+, CD4+, CD8+, CD4+/CD8+) will be measured as exploratory outcomes. In addition, adverse events will be screened and documented throughout the study. An analysis adhering to the intention-to-treat(ITT) principle will be executed.

This research aims to evaluate the efficacy and safety of moxibustion in patients with gastrointestinal CRF. Additionally, the study seeks to investigate the effects of moxibustion on the immune response in individuals diagnosed with gastrointestinal CRF.