Impact of Exercise on Mitochondria in Cancer Patients.

NCT04558398 | Completed

• 1 other identifier: 21018
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The aim is to investigate the impact of prostate and colorectal cancer on mitochondrial quantity and quality along with muscle mass and function and whether this can be modified through the use of a home-based short-term exercise training program. The investigators aim to recruit participants awaiting curative surgery for colorectal and prostate cancer and to assess the variation in baseline mitochondrial activity between them. Participants from both cancer types will then carry out a 4 week home exercise program, this will be randomly allocated to either resistance-based or high-intensity interval training based. Participants will then be re-assessed on the day of their planned surgical procedure to assess the changes effected by the training program. The investigators hypothesize that there will be variation in mitochondrial activity linked to muscle mass across the two cancer types and that home-based exercise programs have the ability to improve mitochondrial activity along with muscle mass.

Conditions

Prostate Cancer; Colorectal Cancer

Keywords

Mitochondrial activity; Resistance exercise training; High-intensity interval training

Outcome Measures

Primary Outcomes (3)

• Mitochondrial activity across 2 cancer types

  Mitochondrial oxidative phosphorylation capacity between colorectal and prostate cancer. Mitochondrial oxidative phosphorylation capacity will be measured according to oxygen consumption determined by the use of a high-definition respirometer. This will then be compared across cancer types and expressed as a ratio of maximal consumption.

  Assessed at initial baseline study day across cancer types

• Mitochondrial activity change with a short-term home-based exercise program

  The effect of either a resistance exercise-based and high-intensity interval training-based home-based training program on mitochondrial function. Mitochondrial oxidative phosphorylation capacity will be measured according to oxygen consumption determined by the use of a high-definition respirometer. The changes seen throughout the treatment will then be expressed as a percentage in order to express the changes seen from the baseline.

  Assessed over the 4-weeks prior to planned surgical resection

• The altered response to training - type between cancer type.

  The differing responses between cancer type to the short-term exercise training. Mitochondrial oxidative phosphorylation capacity will be measured according to oxygen consumption determined by the use of a high-definition respirometer. The changes caused by the training regimen will then be expressed as a percentage in order to express the changes seen from the baseline, and in order to allow comparison between cancer type.

  4-weeks

Secondary Outcomes (2)

• The difference in muscle-function compared between cancer types, and its change throughout a short-term exercise program.

  4-weeks

• The effect of cancer types and exercise on myokine expression.

  4-weeks

Study Arms (2)

Resistance exercise training group

EXPERIMENTAL

Participants randomized to this arm will engage in a 4-week home-based training program with anticipated 12 sessions (3 per week) with participants required to attend a minimum of 9 sessions.

Other: Resistance exercise training

High-intensity interval training group

EXPERIMENTAL

Participants randomized to this arm will engage in a 4-week home-based training program with anticipated 12 sessions (3 per week) with participants required to attend a minimum of 9 sessions.

Other: High-intensity interval training

Interventions

Resistance exercise training OTHER

Each session will be performed at home, with resistance bands used to provide resistance. Participants will be guided to increase the resistance if over 15 repetitions can be performed prior to fatigue. Weekly contact will be made with participants to encourage participation and to guide the exercise. Each session will include: 2 min warm-up jogging on the spot 2 sets of 12-15 repetitions of: Squats Hip flexion Hip extension Hip abduction Seated row Bench press Lateral raises 2 min jogging on the spot cooldown.

Resistance exercise training group

High-intensity interval training OTHER

Each session will include: * 2 min warm-up: jogging on the spot * Each of the following exercises performed for 60seconds, interspaced by 90 seconds rest * Star jumps * Standing squats * On-the-spot sprints * Standing squats * Star jumps * 2 min cool-down: jogging on the spot Participants will be contacted weekly to encourage participation and to guide the exercise

High-intensity interval training group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 50 years and over (no upper age limit)
• Male patients
• Histologically confirmed malignancy, radiologically or direct visualisation leading to high clinical suspicion of cancer with planned surgical resection as treatment option (prostate or colorectal).
• Sufficient mobility to be able to complete a home-based exercise program
• Capacity to give informed and written consent
• Ability to travel to the RDH to complete the assessment session

You may not qualify if:

• Current participation in a formal exercise regime
• Inability to complete exercise training
• Inadequate level of the English language to be able to provide consent
• A BMI \<16.5 or \>35 kg/m2
• Active cardiovascular disease:
• Uncontrolled hypertension (BP \> 160/100)
• Angina
• Heart failure (class III/IV)
• Significant arrhythmia
• Right to left cardiac shunt
• Recent cardiac event
• Taking beta-adrenergic blocking agents
• Cerebrovascular disease:
• g. Previous stroke h. Aneurysm (large vessel or intracranial) i. Epilepsy
• Respiratory disease including:

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Thomas Smart

Derby, Derbyshire, DE22 3NE, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Colorectal Neoplasms

Interventions

Resistance Training; High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jon Lund, MD MBBS

  Nottingham University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the exercise interventions, there will be no masking
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will all receive baseline assessments of their mitochondrial function, muscle mass and functional assessments. Participants with both cancer types (Prostate and colorectal) will be randomly allocated to either Resistance based or high-intensity interval training based home exercises for 4 weeks prior to their planned surgical date. Participants will then all be re-assessed on the day of their planned surgical procedure.

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: September 22, 2020
• Study Start: August 5, 2021
• Primary Completion: December 30, 2023
• Study Completion: March 30, 2024
• Last Updated: April 29, 2026

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)