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Body Composition in Older Adults

An Exploration of Body Composition in Older Adults Undergoing Systemic Anticancer Treatment.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06630754
Acronym
BODI
Enrollment
30
Registered
2024-10-08
Start date
2024-11-01
Completion date
2025-06-01
Last updated
2024-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Composition Changes, Cachexia; Cancer; Sarcopenia, Nutrition, Older Adults, Sarcopenia in Elderly

Brief summary

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.

Interventions

OTHERNo Intervention: Observational Cohort

No intervention; observation cohort study

Sponsors

Nutricia UK Ltd
CollaboratorINDUSTRY
Royal Marsden NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adults eligible and accepting of assessment in the SAOP. 1. adults aged 70 years and over 2. a cancer diagnosis 3. just starting SACT 4. able to provide at least 2 data sets during the study period (baseline + at least 1 research clinic visit) 5. willing and able to provide written informed consent

Exclusion criteria

* No further exclusions

Design outcomes

Primary

MeasureTime frameDescription
Explore body composition in older adults with cancer starting SACT.7 monthsmeans 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

MeasureTime frameDescription
Explore the extent of body composition changes in older adults with cancer during SACT.7 monthspercentage 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

MeasureTime frameDescription
Explore whether there are differences between body composition in older adults with cancer receiving SACT, based on tumour diagnosis7 monthsTumour 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.7 monthsnutritional 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.7 monthsstandardised 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.

Countries

United Kingdom

Contacts

Primary ContactLucy Eldridge, M.Sc. (Hons) Cancer Care Award
lucy.eldridge@rmh.nhs.uk4420 8661 3066
Backup ContactMegan Pattwell, PGDip Dietetics
megan.pattwell@rmh.nhs.uk4420 8661 3066

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026