Clinical trial NCT06630754: Body Composition in Older Adults
Official title: An Exploration of Body Composition in Older Adults Undergoing Systemic Anticancer Treatment.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sarcopenia in Elderly
Cachexia; Cancer; Sarcopenia
Body Composition Changes
Older Adults
Nutrition
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Nutricia UK Ltd
First posted: 2024-10-08
Enrollment: 30
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Explore body composition in older adults with cancer starting SACT.
timeFrame: 7 months
Secondary outcomes:
measure: Explore the extent of body composition changes in older adults with cancer during SACT.
timeFrame: 7 months
Other outcomes:
measure: Explore whether there are differences between body composition in older adults with cancer receiving SACT, based on tumour diagnosis
timeFrame: 7 months
measure: Explore how body composition can inform nutritional management of older adults with cancer receiving SACT.
timeFrame: 7 months
measure: Investigate the incidence for cancer-related cachexia and sarcopenia in older adults with cancer receiving SACT.
timeFrame: 7 months
Locations:
city: London
country: United Kingdom
facility: Royal Marsden Hospital
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Lucy Eldridge, M.Sc. (Hons) Cancer Care Award
role: STUDY_DIRECTOR
affiliation: Royal Marsden NHS Foundation Trust
name: Megan Pattwell, PGDip Dietetics
role: PRINCIPAL_INVESTIGATOR
References: