About this trial
The primary aim of the study is to explore body composition in older adults (aged 70 years and over) with cancer, undergoing systemic anticancer treatment. Additional aims include to explore the extent of body composition changes and whether changes are tumour specific, the incidence for cancer-related cachexia and sarcopenia and finally, how body composition can inform nutritional management of older adults with cancer.
To do this, the investigators applied for and were awarded funding from a company called Nutricia to pay for a band 4 (0.6 WTE for 7 months) to take monthly body composition measures on the patients who are eligible, accepting of assessment by the Senior Adult Oncology Programme (SAOP) and consent to these measures. Measurements will include an analysis from the Bioelectrical Impedance Analysis (BIA) machine which will quantify fat, lean muscle, and water content; waist to hip ratio; handgrip strength; calf circumferences. Socio-demographic data will also be collected.
Descriptive data analysis will take place to explore possible trends and associations which may inform future research and drive even further personalised care for this growing and typically underrepresented in research, population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults eligible and accepting of assessment in the SAOP.
adults aged 70 years and over
a cancer diagnosis
just starting SACT
Disqualifiers
No further exclusions
Trial population
adults aged 70 years and older, with a cancer diagnosis who are to receive systemic anti-cancer treatment
Trial design
Cohort
Prospective
Treatments tested in this trial
No Intervention: Observational Cohort
Other interventionNo intervention; observation cohort study
Treatment groups
Trial outcomes
Primary outcomes
Explore body composition in older adults with cancer starting SACT.
means and standard deviations (or medians and interquartile ranges if not normally distributed) of body composition measures taken from all participants at baseline/ first Research Clinic, analysed at end of study will quantify this objective.
Secondary outcomes
Explore the extent of body composition changes in older adults with cancer during SACT.
percentage change between body composition measures taken from all participants at baseline and during monthly Research Clinics, analysed at end of study will quantify this objective.
Other outcomes
Explore whether there are differences between body composition in older adults with cancer receiving SACT, based on tumour diagnosis
Tumour types will be categorised with frequencies reported. Means calculated from Exploratory Endpoint #2 of each category will be compared at end of study and quantify this objective.
Explore how body composition can inform nutritional management of older adults with cancer receiving SACT.
nutritional interventions provided (if any) will be categorised and cross-examined for correlations with mean percentage change in body composition (Outcome #2) at end of study to quantify this objective.
Investigate the incidence for cancer-related cachexia and sarcopenia in older adults with cancer receiving SACT.
standardised cut off values (World Health Organization, 2011; Cruz-Jentoft et al., 2019; Roeland et al., 2020) for indicating the presence of cancer-related cachexia and sarcopenia will be extracted from body composition measures taken from all participants at baseline and during monthly Research Clinics and presented as an overall frequency (of participants) and frequencies within each tumour type. Analysis will occur at end of study and will quantify this objective.
Sponsors and contacts
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Royal Marsden NHS Foundation Trust
Lead sponsor
Nutricia UK Ltd
Collaborator
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