Effects of a Strength Physical Exercise Program in Colorectal Cancer Patients Undergoing Chemotherapy Treatment

NCT06404359 | Not Yet Recruiting

• 1 other identifier: OncoExercise
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Chemotherapy is a crucial treatment in the fight against colon cancer, but unfortunately, its impact is not limited to cancer cells alone. Chemotherapy drugs, designed to attack fast-growing cells, also affect healthy tissues, leading to various side effects. One of the most common adverse effects is peripheral neuropathy, a condition that affects the peripheral nerves and can manifest as tingling sensations, numbness, pain or weakness in the extremities. Chemotherapy-induced peripheral neuropathy can be especially challenging for colon cancer patients, as it further aggravates quality of life during an already difficult period. Nerves responsible for motor and sensory function are compromised, affecting the patient's ability to perform daily activities and weakening their physical endurance. This phenomenon adds to the emotional and physical burden of fighting cancer. However, there are tools that can positively influence these adverse effects, such as physical exercise. Although it may seem contradictory, regular physical exercise has been shown to have beneficial effects on peripheral neuropathy. Physical exercise can improve blood circulation and promote regeneration of damaged peripheral nerves. In addition, exercise helps to alleviate the pain and discomfort associated with neuropathy, thereby strengthening patients' functional capacity. It is essential to emphasize that any exercise plan must be tailored to the individual capabilities of each patient, and medical supervision is essential. Therefore, the combination of chemotherapy and carefully planned physical exercise offers a comprehensive strategy to address both the disease and its side effects, providing colon cancer patients with a better quality of life during their journey to recovery.

Conditions

Oncology; Chemotherapy-induced Peripheral Neuropathy

Keywords

Exercise; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• Chemotherapy-induced neuropathy

  The EORTC CIPN20 questionnaire will be used.This questionnaire contains 20 items on which patients rate their experience for each symptom during the previous week using scores from 1 (not at all) to 4 (very much). The sum score was obtained by adding the scores of items 1 to 19 resulting in a sum score range of 19 to 76, which was termed CIPN20 sum1-19. Item 20 rates male impotence

  Baseline and immediately after the intervention

Secondary Outcomes (8)

• Wellbeing

  Baseline and immediately after the intervention

• Body Mass Index

  Baseline and immediately after the intervention

• Oxygen consumption

  Before and after the intervention

• Anxiety and depression

  Baseline and immediately after the intervention

• Fatigue

  Baseline and immediately after the intervention

Study Arms (2)

Exercise group

EXPERIMENTAL

The investigators propose a 12-week intervention with therapeutic strength exercise in patients with colorectal cancer who are receiving chemotherapy treatment.

Other: Exercise

Control group

ACTIVE COMPARATOR

They will be provided with clear and concrete recommendations of activities for the user to perform the rest of the days of the week in order to increase their level of physical activity and increase weekly metabolic expenditure.

Other: Physical activity recommendations

Interventions

Exercise OTHER

There will be 2 weekly sessions of 50 minutes, always guided by a physiotherapist, with the following distribution: 1.- Warm-up: 15 minutes of global exercises of strength and resistance, focusing on the areas that are going to be worked as a priority in that session. Strength training: 6 to 8 strength exercises of large muscle groups. The approximate duration will be 25 minutes. 3.- Cool down / cool down: Combination of breathing exercises and stretching, 10 minutes. Monitoring with activity bracelets.

Exercise group

Physical activity recommendations OTHER

They will be provided with a physical activity plan to be followed on a weekly basis.

Control group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People diagnosed with colorectal cancer and who are receiving chemotherapy treatment.
• Sedentary people who have not performed physical activity in the last 8 weeks.
• Ability to understand the evaluation tests and the performance of the exercises.
• Voluntary participation in the study.

You may not qualify if:

• \- Present contraindication/s for physical exercise (musculoskeletal diseases, severe cardiovascular disease, bone metastases,...).

Sponsors & Collaborators

• Juan Luis Sanchez Gonzalez: lead

MeSH Terms

Conditions

Neoplasms; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Juan Luis Sánchez González, Phd

CONTACT

923294500; juanluissanchez@usal.es

Carlos Martín Sánchez, Phd

CONTACT

923294500; carlos_ms@usal.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator. Dr. Juan Luis Sánchez González

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 8, 2024
• Study Start: June 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05