Exercise and Nutritional Rehabilitation in Patients With Cancer

NCT03316157 | Completed

• 1 other identifier: AC17085
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

In patients with incurable cancer, general deterioration in their ability to walk, exercise and care for themselves is often regarded as an inevitable consequence of this. In 2015, Hospice UK published a report advocating "Rehabilitative Palliative Care". However there is limited robust evidence on which to base this approach. Reviews of the literature show limited study numbers but do suggest that rehabilitation may be feasible for advanced cancer patients. However key components were not clear and no recommendations could be given. This trial is designed primarily to test the feasibility of a rehabilitation programme (exercise and nutritional supplementation) in advanced cancer patients. Feasibility will be the primary outcome measure including rates of recruitment and compliance. Secondary outcome measures include impact on physical function, nutritional status, quality of life for patients and their carers. We will also assess the health economic impact by assessing patient health facility use throughout the trial. 40 patients with advanced cancer living in the community will be recruited from two hospice palliative care teams in Edinburgh. These patients will be randomised in to either the treatment arm: the rehabilitation programme plus standard care, or the control arm: standard care alone. The treatment arm will consist of an 8 week rehabilitation programme, supervised at weekly clinics by a physiotherapist and dietician. To minimise contamination the control group will be offered the treatment at the end of the 8 weeks (waiting list control). Measurements will be made for both groups and compared at baseline (week 0), midpoint (week 5) and endpoint (week 9). Recommendations for a larger UK wide trial will be made from the findings of this study.

Conditions

Cachexia; Cancer; Diet Modification; Physical Activity; Advanced Cancer

Outcome Measures

Primary Outcomes (1)

• Feasibility of Rehabilitation programme

  Compliance with treatment and trial procedures

  8 weeks

Secondary Outcomes (12)

• Patient quality of life

  8 weeks

• Carer quality of life

  8 weeks

• Change in physical function

  8 weeks

• Change in physical function

  8 weeks

• Change in physical function

  8 weeks

Study Arms (2)

Rehabilitation

EXPERIMENTAL

Advanced cancer patients will receive an 8 week rehabilitation intervention consisting of physical exercise and nutritional supplementation, along with standard care

Dietary Supplement: ProSure; Behavioral: Physical Exercise

Waiting list Control

NO INTERVENTION

Standard care alone for the 8 week trial period, followed by participants being offered the rehabilitation programme

Interventions

ProSure DIETARY_SUPPLEMENT

Patients will take 2x 220mL nutritional supplements per day for 8 weeks and be given dietary advice to optimise their nutrition

Rehabilitation

Physical Exercise BEHAVIORAL

Patients will receive an individualised exercise regimen consisting of 60 minutes aerobic and 3x resistance elements per week

Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of advanced cancer (defined as metastatic or locally advanced cancer not amenable to curative treatment).
• Outpatient
• ≥18years
• Karnofsky score ≥ 60
• Prognosis greater than 3 months
• Able to complete trial based assessments
• Under care of community services at Marie Curie or St Columba's Hospices
• Ability to comply with trial protocol
• Ability to provide and have capacity to consent
• Agree to attend trial centre for trial related activity (St Columba's Hospice)

You may not qualify if:

• Undergoing anti-cancer therapy (hormonal treatment or bisphosphonates permitted)
• Using enteral nutrition (NG or similar) or parenteral nutrition
• Co-enrolment in drug trials
• Inability to swallow

Sponsors & Collaborators

• University of Edinburgh: lead
• Marie Curie Hospice, Belfast: collaborator
• Accord Clinical Research: collaborator
• NHS Lothian: collaborator

Study Sites (1)

University of Edinburgh

Edinburgh, EH4 2XR, United Kingdom

Location

MeSH Terms

Conditions

Cachexia; Neoplasms; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised (1:1) unblinded feasibility trial of a rehabilitation programme (exercise and nutrition) versus waiting list control, in patients with advanced cancer

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: October 20, 2017
• Study Start: January 30, 2018
• Primary Completion: April 24, 2019
• Study Completion: July 3, 2019
• Last Updated: March 11, 2020

Record last verified: 2020-03

Locations

GB (1)