Body Composition in Older Adults

NCT06630754 | Not Yet Recruiting

• 1 other identifier: CCR6064
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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.

  7 months

Secondary Outcomes (1)

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

  7 months

Other Outcomes (3)

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

  7 months

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

  7 months

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

  7 months

Study Arms (1)

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

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort OTHER

No intervention; observation cohort study

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

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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

You may qualify if:

• 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

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• Nutricia UK Ltd: collaborator

Study Sites (1)

Royal Marsden Hospital

London, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Cachexia; Neoplasms; Sarcopenia

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Study Officials

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

  Royal Marsden NHS Foundation Trust

  STUDY DIRECTOR

• Megan Pattwell, PGDip Dietetics

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

4420 8661 3066; lucy.eldridge@rmh.nhs.uk

Megan Pattwell, PGDip Dietetics

CONTACT

4420 8661 3066; megan.pattwell@rmh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: October 8, 2024
• Study Start: November 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

GB (1)