Randomized Multicenter Trial Evaluating Non-Drug Interventions to Reduce Neurotoxicity in Hematologic Cancer Patients Receiving CAR-T Therapy

What this Trial Is About

Researchers are investigating whether two non-drug approaches can reduce neurotoxicity caused by CAR-T cell therapy in adults aged 18 to 80 with hematologic cancer. The study compares a structured physical activity program alone and combined with nutritional recommendations against a control group with no intervention. It aims to find out if these approaches lower the risk or severity of neurotoxicity and improve patient recovery after CAR-T therapy. The study is a randomized, multicenter clinical trial enrolling 100 participants. Those in Group A follow a supervised physical activity program including aerobic and resistance exercises tailored to their fitness level. Group B combines this physical activity with personalized nutritional advice based on the Mediterranean diet. The control Group C receives no intervention. Interventions start at least one month before CAR-T infusion and continue for at least one month after treatment. Participants are evaluated weekly before, during, and for four weeks after CAR-T therapy by the same multidisciplinary team at the hospital. Researchers collect detailed data on symptoms, health status, physical activity, nutrition, quality of life, and adherence to interventions. The main outcome measured is the incidence and severity of neurotoxicity up to six months post-therapy. Secondary outcomes include functional independence, nutritional status, and physical activity levels to assess overall benefit and safety.

Non-Pharmacological Interventions for Neurotoxicity in Hematologic Patients Receiving CAR-T Therapy