Is a lifestyle intervention designed to support muscle mass in people with advanced bowel cancer during their chemotherapy feasible?

Not Applicable

• Conditions: Advanced (unresectable and/or metastatic) colorectal cancer undergoing chemotherapy; Cancer

• Registration Number: ISRCTN58882854
• Lead Sponsor: Queen's University Belfast

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-26
• Last Update Posted: 5 August 2024
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Main participants:
1. Age of at least 18 years.
2. Histologically-confirmed unresectable Stage III or Stage IV adenocarcinoma of the colon or rectum.
3. Planned for systemic anti-cancer treatment (SACT) with a 5-flourouracil-based regimen with palliative intent.
4. Greater than 12 weeks from any prior SACT.
5. Greater than 4 weeks from any prior major surgery and fully recovered.
6. ECOG performance status 0-2 and anticipated life expectancy greater than 4 months.
7. Adequate haematological, renal and hepatic function to undergo standard of care SACT as assessed by treating oncologist.
8. Medical clearance by treating physician to undergo symptom-limited muscle strength testing, physical function testing, and tailored resistance-based exercise training.
9. Ability (i.e. sufficiently fluent) and willingness to effectively communicate with the Physical Activity and Nutrition Coach.
10. Willingness to eat an unrestricted diet. Includes participants willing to eat an otherwise unrestricted vegetarian diet.
11. Ability to provide written informed consent.

Nominated friend/family members (for questionnaires and interview):
1. One person nominated by the main study participant.
2. Ability to provide written informed consent.

Healthcare professionals involved in study (for interview).
1. Ability to provide written informed consent.

Potential participants who decline to participate (for interview):
1. Ability to provide written informed consent.

Exclusion Criteria

1. Significant cognitive impairment or co-morbid conditions precluding participation in a resistance-training programme as determined by the investigator.
2. Peripheral neuropathy > grade 2.
3. Unlikeliness to participate in a physical activity and nutrition intervention as determined by the investigator.
4. Patients undergoing adjuvant-intent chemotherapy in the setting of radically treated oligometastatic hepatic disease.
5. Concurrent treatment for a second malignancy.
6. Treatment with any medications deemed by the investigator as likely to preclude participation in a resistance-training programme.
7. Individual already participating in structured resistance-training = 2 days per week.

No specific exclusion criteria for nominated friends/family members, healthcare professionals, and non-participants taking part in questionnaires and interviews.

Study & Design

• Study Type: Interventional
• Study Design: Not specified