FASTINA - protocol for a randomised feasibility trial of time-restricted eating to improve response to multiple...

Multiple myeloma (MM) is an incurable plasma cell malignancy with relapses and diminishing response durations. Preclinical studies suggest that time-restricted eating (TRE)-related metabolic changes may enhance chemosensitivity by exploiting cancer cell vulnerabilities to nutrient deprivation. Clinical data in solid tumours remain limited and heterogeneous, mainly supporting feasibility and possible toxicity reduction rather than definitive efficacy. While efficacy has been explored in breast cancer patients, there is a lack of data for haematological patients, including MM. FASTINA (Fasting in Staging of MM - Intervention for Nutritional Adherence) will therefore primarily assess feasibility and safety and will explore preliminary efficacy of incorporating TRE into standard MM therapy. FASTINA is a single-centre, open-label, parallel-group randomised controlled feasibility trial (DRKS00034370). 54 adults with MM will be randomised 1:1 to either 16:8 TRE + nutritional counselling or nutritional counselling alone for 12 weeks during systemic therapy. Primary endpoints are adherence to the diet (adherence ≥ 80%) and complete response with measurable residual disease (MRD) negativity at treatment end. Secondary endpoints include response rates, nutritional status, body composition changes, frequency of ≥ grade 3 adverse events (AEs), progression-free (PFS) and exploratory overall survival (OS), quality of life (QoL), and fatigue. FASTINA will evaluate whether TRE is feasible and safe in selected MM patients and whether there is a hypothesis-generating signal for improved treatment response, informing the design of a subsequent phase II trial.Trial registration Deutsches Register Klinischer Studien (DRKS), DRKS00034370. Registered 21 June 2024, https://drks.de/search/de/trial/DRKS00034370 .