Music Interventions on Cancer-Related Fatigue During Chemotherapy: Music for Alleviating Symptoms (MusAS) Trial Rationale and Protocol

Background: Cancer-related fatigue is the most reported symptom of cancer treatment, especially chemotherapy, and is associated with psychological symptoms. Non-pharmacological interventions are recommended for symptom management, including music-based interventions. Methods: The proposed Music for Alleviating Symptoms (MusAS) study is a single-center, non-blind, randomized controlled trial with three parallel arms (two experimental and one control, with usual care) to verify the efficacy of distinct music listening approaches for diminishing adverse events during chemotherapy. A sample of 25 participants per group will be recruited, including women with breast cancer in stages 1 to 3 at a Brazilian oncologic referral hospital. The Music Therapy group will have an individualized interview with a music therapist, who will tailor a personalized playlist to each participant, whereas the Music Medicine group will listen to a standard playlist. The primary outcome is cancer-related fatigue (FACT-F), and the secondary outcomes are health-related quality of life (FACT-G), adverse events, (PRO-CTCAE), anxiety and depression symptoms (HADS), mood (VAMS), and the biological markers of inflammation (CRP, IL-6, IL-10, and Interferon-gamma). Results: The results will inform the potential integration of music-based interventions in clinical practice for managing cancer-related fatigue and other associated symptoms. Conclusions: The strengths of MusAS are the inclusion of a homogeneous population and the incorporation of biomarkers as an objective measure. To our knowledge, this is the first 3-arm trial with music in oncology from Latin America. It is registered in the Brazilian Register of Clinical Trials (ensaiosclinicos.gov.br), code RBR-68w9xsy.