Acupuncture for fatigue in breast cancer survivors: a study protocol for a pragmatic, mixed method, randomised controlled trial.

ABSTRACT

INTRODUCTION: Fatigue is a common symptom observed in post-cancer treatment, yet its underlying mechanisms remain poorly understood. Acupuncture has been employed to alleviate cancer-related fatigue (CRF); however, its effectiveness in addressing associated comorbidities that may influence fatigue is also poorly understood. This study represents the first investigation to use acupuncture as an intervention for fatigue in breast cancer survivors within a Norwegian cohort. The study will employ questionnaires to evaluate various facets of fatigue. As a pragmatic trial, it statistically assesses its clinical relevance, documents adverse events and evaluates the cost-effectiveness of the acupuncture treatment. METHODS AND ANALYSIS: This assessor-blinded, pragmatic, randomised, mixed method, controlled trial with two parallel arms aims to evaluate the effectiveness, safety and cost-effectiveness of acupuncture. It will recruit 250 participants presented with CRF for 6 months or longer. Patients will be randomly allocated either to acupuncture and usual care (n=125) or to usual care alone (n=125). Acupuncture treatments (12 in total) are to be given within 12 weeks. The statistician who will analyse the data will be blinded to group allocation. The primary outcome will be changes in CRF measured by the Chalder fatigue scale. Measurements will be taken 12 weeks and 6 months after randomisation. The secondary outcomes include patient-reported outcomes of pain, anxiety, depression, hot flashes, insomnia and sleepiness. Health-related quality of life and economic evaluation will also be conducted 12 weeks and 6 months after randomisation. Nested within this randomised controlled trial are two qualitative studies and one sub-study measuring biomarkers (C-reactive protein, interleukin (IL)-1, IL-6, tumour necrosis factor alpha (TNF-α) and aPL in addition to the current genotype genes TNF-308 and IL-6-174) from blood samples (n=80). Such biomarkers can potentially address changes in CRF. ETHICS AND DISSEMINATION Ethical approval of this study has been granted by the Regional Committees for Medical and Health Research Ethics (REC southeast ID number 112285). Written informed consent will be obtained from all participants. The outcomes of the trial will be disseminated through peer-reviewed publications. TRIAL REGISTRATION NUMBER NCT04418115.