Prehabilitation in Patients With Cancer and Type 2 Diabetes

NCT05547594 | Recruiting

• 1 other identifier: UoG_2022_CT2D_Prehab
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Surgical prehabilitation refers to pre-operative interventions aimed at increasing patients' physiological reserve so that they can better cope with the stress of surgery, avoid post-operative complications and have a faster recovery after surgery. Multimodal prehabilitation combines different aspects related to a healthy lifestyle including but not limited to; physical activity, nutritional education, anxiety coping strategies, alcohol moderation and smoking cessation. Although these aspects are well known, having a cancer diagnosis and the likelihood of an incoming operation during the weeks after diagnosis, place patients in a situation where they may be more receptive to adopting lifestyle changes aimed at promoting health. Such changes could be incorporated, not just in the short-term in preparation for surgery, but also in the medium- and long-term, improving patients' wellbeing and potentially reducing the risk of cancer reoccurrence and other diseases. Although the benefits of prehabilitation before surgery are understood, the effects it may have in non-insulin-dependent Type 2 diabetes patients are unknown. This project aims to: (i) Analyse the effects of a multimodal prehabilitation programme vs. the current National Health Service (NHS) standard approach, on physical performance in cancer patients with non-insulin-dependent Type 2 diabetes prior to surgery. (ii) Explore the impact of the programme on body composition and metabolic markers. (iii) Analyse the programme adherence, markers of well-being and quality of life during a post-surgery period of up to 12 months as well as its effects on clinical outcomes.

Conditions

Cancer; Type 2 Diabetes

Keywords

cancer; Type 2 diabetes; surgery; prehabilitation; recovery; exercise; nutrition; protein; anxiety; quality of life; physical performance

Outcome Measures

Primary Outcomes (1)

• Changes in Short Physical Performance Battery (SPPB) at different time points from baseline to 1 year after surgery

  Group of measures that combines the results of the gait speed, chair stand and balance tests, with scores ranging from 0 (worst performance) to 12 (best performance).

  upon enrolment, before surgery, 6 weeks after surgery, 6 and 12 months after surgery

Secondary Outcomes (6)

• Changes in fasting glucose at different time points from baseline to 1 year after surgery

  upon enrolment, before surgery, 6 weeks after surgery, 6 and 12 months after surgery

• Changes in fasting insulin at different time points from baseline to 1 year after surgery

  upon enrolment, before surgery, 6 weeks after surgery, 6 and 12 months after surgery

• Changes in BMI at different time points from baseline to 1 year after surgery

  upon enrolment, before surgery, 6 weeks after surgery, 6 and 12 months after surgery

• Changes in waist circumference at different time points from baseline to 1 year after surgery

  upon enrolment, before surgery, 6 weeks after surgery, 6 and 12 months after surgery

• Changes in hip circumference at different time points from baseline to 1 year after surgery

  upon enrolment, before surgery, 6 weeks after surgery, 6 and 12 months after surgery

Other Outcomes (3)

• Hospital length of stay

  8 weeks after surgery

• 90-day readmission

  90 days after surgery

• Postsurgical complications

  6 months after surgery

Study Arms (2)

Prehabilitation

EXPERIMENTAL

Arm undergoing multimodal prehabilitation (physical activity, nutritional education and anxiety management) during the weeks leading up to surgery

Behavioral: Multimodal surgical prehabilitation

Standard of care

NO INTERVENTION

Arm receiving standard of care (no prehabilitation)

Interventions

Multimodal surgical prehabilitation BEHAVIORAL

Participants will be encouraged to engage in regular physical activity (endurance and resistance exercise), eat healthily and undergo cognitive behavioural therapy (the latter only if required) during the weeks prior to surgery.

Prehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capacity to give consent
• Newly diagnosed with cancer
• Non-insulin-dependent Type 2 diabetes
• Awaiting surgery for cancer

You may not qualify if:

• Medical contraindication to engage in physical activity

Sponsors & Collaborators

• University of Greenwich: lead

Study Sites (2)

School of Human Sciences, University of Greenwich, Avery Hill Campus, Sparrows Farm (Office SF112B)

Eltham, England, SE9 2BT, United Kingdom

NOT YET RECRUITING

King's College Hospital

London, United Kingdom

RECRUITING

Related Publications (1)

• Wu F, Rotimi O, Laza-Cagigas R, Rampal T. The Feasibility and Effects of a Telehealth-Delivered Home-Based Prehabilitation Program for Cancer Patients during the Pandemic. Curr Oncol. 2021 Jun 17;28(3):2248-2259. doi: 10.3390/curroncol28030207.

  PMID: 34204531 RESULT

MeSH Terms

Conditions

Neoplasms; Diabetes Mellitus, Type 2; Motor Activity; Anxiety Disorders

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior; Mental Disorders

Study Officials

• Fernando Naclerio, PhD

  University of Greenwich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando Naclerio, PhD

CONTACT

0044 2083 318441; f.j.naclerio@greenwich.ac.uk

Roberto Laza-Cagigas, MSc

CONTACT

0044 7597 058406; r.lazacagigas@greenwich.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Strength Training and Sports Nutrition

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 21, 2022
• Study Start: January 18, 2024
• Primary Completion: January 30, 2025
• Study Completion: April 30, 2025
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)