Assessment of nutritional status and energy expenditure in CAR T Cell
Research type
Research Study
Full title
Observational study of changes in nutritional status, body composition and energy expenditure in haematology patients receiving Chimeric Antigen Receptor (CAR) T-cell therapy and its association with clinical outcomes (CAR-NSEE)
IRAS ID
313347
Contact name
Nathan Davies
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2022/11/92 , UCL Data Protection Number
Duration of Study in the UK
1 years, 0 months, 26 days
Research summary
Reprogramming the body’s own immune system to attack previously incurable cancers is the basis for the revolutionary field of CAR T-cell therapy. This treatment is offering hope where all others have failed; however, it has several understudied side effects on the body, including the impact of its unique mechanism on nutritional status, bodyweight and metabolism. In standard anti-cancer therapies, patients experience increased rates of malnutrition and cachexia, both of which result in increased morbidity and mortality, including reduced response to cancer treatment, increased severity of side effects, reduced quality of life and poorer prognoses. Through our preliminary research, we have identified significant rates of malnutrition and muscle-wasting in CAR T-cell patients, resulting in increased length of hospital stays, greater ICU requirements, and higher mortality rates. Although this demonstrates a serious problem, robust research is required to understand the true prevalence and impact of this treatment’s various nutritional issues, and to develop future preventative interventions.
This is our prospective pilot study’s aim; using highly sensitive, gold standard methods, we are pioneering the first evidence-based investigation of the nutritional and metabolic changes occurring for adult (≥18 years) haematological patients receiving CAR T-cell therapy at UCLH. By taking repeated measures pre, during and post-treatment, assessing changes to patients’ body composition (including FFM and SMM) and REE (see Gantt chart below), uniquely combined with inflammatory blood marker biochemical analysis, we will be the first internationally to uncover the relationship between CAR T-cells, nutritional status, and patient outcomes. Without this research, the detrimental effects of malnutrition and muscle-wasting seen in our preliminary results will continue to impact this already vulnerable population, and subsequently limit CAR T-cell therapy’s expansion across a broad range of currently untreatable cancers.
Core funding for this research is provided through UCL Division of Medicine.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
23/LO/0482
Date of REC Opinion
11 Jul 2023
REC opinion
Further Information Favourable Opinion