Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06630754

Body Composition in Older Adults

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Sarcopenia in Elderly Atrophy Body Composition Changes Body Weight Body Weight Changes Cachexia Cachexia; Cancer; Sarcopenia Muscular Atrophy Neoplasms Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutrition Older Adults Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms Thinness Weight Loss

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Marsden Hospital

London, SM2 5PT, United Kingdom

Location contact

Mark Brandon-Grove

CONTACT

[email protected]

4420 3186 5416

Megan Pattwell

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No further exclusions

Treatment and study plan

No Intervention: Observational Cohort

Other

No intervention; observation cohort study

Primary outcomes

  1. Explore body composition in older adults with cancer starting SACT.

    Time frame: 7 months

    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

  1. Explore the extent of body composition changes in older adults with cancer during SACT.

    Time frame: 7 months

    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

  1. Explore whether there are differences between body composition in older adults with cancer receiving SACT, based on tumour diagnosis

    Time frame: 7 months

    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.

  2. Explore how body composition can inform nutritional management of older adults with cancer receiving SACT.

    Time frame: 7 months

    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.

  3. Investigate the incidence for cancer-related cachexia and sarcopenia in older adults with cancer receiving SACT.

    Time frame: 7 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lucy Eldridge, M.Sc. (Hons) Cancer Care Award

CONTACT

[email protected]

4420 8661 3066

Megan Pattwell, PGDip Dietetics

CONTACT

[email protected]

4420 8661 3066

Sponsors and collaborators

Lead sponsor

Royal Marsden NHS Foundation Trust

Other

Collaborators

  • Nutricia UK Ltd

Registry information

Official study title

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

Acronym: BODI

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 8, 2024
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.