Sarcopenia in ElderlyBODINCT06630754
Body Composition in Older Adults
An observational study of Sarcopenia in Elderly and Cachexia; Cancer; Sarcopenia, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Sarcopenia in Elderly, Cachexia; Cancer; Sarcopenia, Body Composition Changes
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2024to 1 Jun 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: adults aged 70 years and older, with a cancer diagnosis who are to receive systemic anti-cancer treatment
Who may be able to join
- 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
Who cannot join
- No further exclusions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Royal Marsden Hospital
London, SM2 5PT
Mark Brandon-Grove, 4420 3186 5416, mark.brandon-grove@rmh.nhs.uk
Megan Pattwell
About this study
Official title: 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.
- Conditions
- Sarcopenia in Elderly, Cachexia; Cancer; Sarcopenia, Body Composition Changes, Older Adults, Nutrition
- Being tested
- No Intervention: Observational Cohort
- Medical subject headings
- Cachexia, Neoplasms, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No intervention; observation cohort study
| Study group | Role | What they receive |
|---|---|---|
| adults aged 70yrs and older, eligible, and accepting of assessment in the SAOP. | Not described Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcopenia in ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Nutricia UK Ltd
- Responsible party
- Sponsor
- Investigators
- Lucy Eldridge, M.Sc. (Hons) Cancer Care Award, Study director, Royal Marsden NHS Foundation TrustMegan Pattwell, PGDip Dietetics, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630754
- Sponsor's protocol ID
- CCR6064
- Acronym
- BODI
- Status last verified
- Oct 2024
- First submitted
- 19 Sep 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploration of Body Composition in Older Adults Undergoing Systemic Anticancer Treatment.
- ClinicalTrials.gov ID
- NCT06630754
- Acronym / sponsor ID
- BODI / CCR6064
- Conditions
- Sarcopenia in Elderly, Cachexia; Cancer; Sarcopenia, Body Composition Changes, Older Adults, Nutrition
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Nutricia UK Ltd
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adults aged 70yrs and older, eligible, and accepting of assessment in the SAOP. | – | Other: No Intervention: Observational Cohort |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- adults aged 70 years and older, with a cancer diagnosis who are to receive systemic anti-cancer treatment
Key inclusion criteria (6 listed)
- Adults eligible and accepting of assessment in the SAOP.
Key exclusion criteria (1 listed)
- No further exclusions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortNo intervention; observation cohort study | Other | adults aged 70yrs and older, eligible, and accepting of assessment in the SAOP. |
Primary outcome
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.
1 secondary outcome
Explore the extent of body composition changes in older adults with cancer during SACT.
Time frame: 7 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia in Elderly and Cachexia; Cancer; Sarcopenia, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucy Eldridge, M.Sc. (Hons) Cancer Care Award (4420 8661 3066, lucy.eldridge@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Explore body composition in older adults with cancer starting SACT. (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.