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Not yet recruitingNCT06630754BODIUpdated Oct 8, 2024

Body Composition in Older Adults

An observational study in Sarcopenia in Elderly, Cachexia; Cancer; Sarcopenia and Body Composition Changes, sponsored by Royal Marsden NHS Foundation Trust. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2024-10-08.

Sponsored by Royal Marsden NHS Foundation Trust · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
70 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Sarcopenia in Elderly
  • Cachexia; Cancer; Sarcopenia
  • Body Composition Changes
  • Older Adults
  • Nutrition
03

In context

Cachexia

336 studies on the registry are indexed under Cachexia; 76 are open to participants now.

This study's planned enrollment of 30 is below the median of 141 across 90 observational studies indexed under Cachexia.

Browse Cachexia studies →

Lead sponsor

Royal Marsden NHS Foundation Trust is the lead sponsor of 272 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

adults aged 70 years and older, with a cancer diagnosis who are to receive systemic anti-cancer treatment

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • No further exclusions
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • adults aged 70yrs and older, eligible, and accepting of assessment in the SAOP.

    Other: No Intervention: Observational Cohort

Interventions

  • OtherNo Intervention: Observational Cohort

    No intervention; observation cohort study

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 7 months

Secondary outcomes

  1. 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.

    Time frame: 7 months

Other outcomes

  1. 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.

    Time frame: 7 months

  2. 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.

    Time frame: 7 months

  3. 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.

    Time frame: 7 months

07

Study locations

1 site
  • Royal Marsden Hospital
    London, SM2 5PT, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06630754
Collaborators
Nutricia UK Ltd
Responsible party
Sponsor
First posted
Oct 8, 2024
Start date
Nov 1, 2024 (estimated)
Primary completion
Jun 1, 2025 (estimated)
Completion
Jun 1, 2025 (estimated)
Last update
Oct 8, 2024

Study contacts

Lucy Eldridge, M.Sc. (Hons) Cancer Care Award
Contact
lucy.eldridge@rmh.nhs.uk
4420 8661 3066
Megan Pattwell, PGDip Dietetics
Contact
megan.pattwell@rmh.nhs.uk
4420 8661 3066
Lucy Eldridge, M.Sc. (Hons) Cancer Care Award
study director · Royal Marsden NHS Foundation Trust
Megan Pattwell, PGDip Dietetics
principal investigator · Royal Marsden NHS Foundation Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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