Erdi Bazhen decoction for cancer-related fatigue due to qi and blood deficiency in prostate cancer patients receiving androgen deprivation therapy: an exploratory randomized, double-blind, placebo-controlled pilot clinical trial protocol

Background Prostate cancer is the most common male genitourinary malignancy in China. Long-term androgen deprivation therapy (ADT) causes severe cancer-related fatigue (CRF), which impairs patients’ physical function and quality of life. Currently, there is a lack of safe, long-term specific pharmacological agents for this condition in Western medicine. From the perspective of traditional Chinese medicine (TCM), qi and blood deficiency is the core pathogenesis underlying the occurrence and progression of CRF. Erdi Bazhen Decoction (EBD) has shown favorable clinical effects on fatigue after ADT in routine practice, but high-quality clinical evidence remains scarce, and key parameters for large-scale confirmatory trials remain undetermined. This exploratory pilot trial aims to investigate the preliminary efficacy and safety of EBD granules for CRF in prostate cancer patients receiving ADT, and to estimate critical trial parameters including effect size, recruitment rate, adherence and dropout rate to inform the design of a future large-scale confirmatory RCT. Methods This single-center, prospective, randomized, double-blind, placebo-controlled parallel pilot trial will enroll 50 eligible patients from a single hospital. Participants will be randomly assigned to two groups at a 1:1 ratio. Both groups will receive routine supportive care for 4 weeks. The intervention group will receive EBD granules, and the control group will receive matched placebo granules. The primary exploratory efficacy endpoint is the change in total score of the revised Piper Fatigue Scale (PFS-R) from baseline to week 4. Secondary outcomes include quality of life, physical performance and TCM syndrome scores; hemoglobin and C-reactive protein levels will be assessed as exploratory biomarkers. Trial feasibility parameters such as recruitment rate, medication adherence and dropout rate will also be descriptively analyzed to inform future trial design. Safety indicators and adverse events will be fully recorded. Variable block randomization without stratification and full double-blinding will be implemented. The primary analysis will be conducted in the intention-to-treat population; a per-protocol analysis will be performed as a sensitivity analysis. All efficacy estimates are exploratory. This protocol was designed in accordance with the SPIRIT 2025 statement; trial results will be reported in accordance with the CONSORT 2025 statement. Conclusion This standardized pilot controlled trial will provide preliminary clinical evidence and essential methodological parameters for EBD in relieving ADT-related fatigue. The results may offer preliminary support for a safe TCM regimen to improve patients’ fatigue, physical status and quality of life, and lay a methodological foundation for integrated Chinese and Western medicine management of prostate cancer-related fatigue. As an exploratory pilot study, the single-center design, small sample size and short intervention period limit the generalizability of confirmatory conclusions. Further large-scale, multi-center, long-term confirmatory trials are needed to verify the long-term effects and population applicability of EBD. Clinical Trial Registration https://itmctr.ccebtcm.org.cn/, identifier [ITMCTR2026001527].