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

NCT ID: NCT06404359

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Exercise group

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

Group Type: EXPERIMENTAL

Exercise

Intervention Type: 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.

Control group

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.

Group Type: ACTIVE_COMPARATOR

Physical activity recommendations

Intervention Type: OTHER

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

Interventions

Exercise

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.

Intervention Type: OTHER

Physical activity recommendations

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Juan Luis Sanchez Gonzalez

OTHER

Sponsor Role: lead

Responsible Party

Juan Luis Sanchez Gonzalez

Principal Investigator. Dr. Juan Luis Sánchez González

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Juan Luis Sánchez González, Phd

Role: CONTACT

juanluissanchez@usal.es

923294500 ext. 3167

Carlos Martín Sánchez, Phd

Role: CONTACT

carlos_ms@usal.es

923294500 ext. 3167

Other Identifiers

OncoExercise

Identifier Type: -

Identifier Source: org_study_id