Body Composition in Older Adults (BODI)

October 4, 2024 updated by: Royal Marsden NHS Foundation Trust

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
adults aged 70yrs and older, eligible, and accepting of assessment in the SAOP.
Other: No Intervention: Observational Cohort
No intervention; observation cohort study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 months
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.
7 months
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.
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Collaborators

Nutricia UK Ltd

Investigators

  • Study Director: Lucy Eldridge, M.Sc. (Hons) Cancer Care Award, Royal Marsden NHS Foundation Trust
  • Principal Investigator: Megan Pattwell, PGDip Dietetics, Royal Marsden NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

September 19, 2024

First Submitted That Met QC Criteria

October 4, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 4, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCR6064

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Older Adults

Clinical Trials on No Intervention: Observational Cohort

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe