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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Oncology; Chemotherapy-induced Peripheral Neuropathy
• Intervention / Treatment: Other: Exercise; Other: Physical activity recommendations

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juan Luis Sánchez González, Phd; Phone Number: 3167 923294500; Email: juanluissanchez@usal.es
• Study Contact Backup: Name: Carlos Martín Sánchez, Phd; Phone Number: 3167 923294500; Email: carlos_ms@usal.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.
• Presence of XXX symptoms (If we focus on neuropathy, it should be inclusion criteria).
• Voluntary participation in the study.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise group; The investigators propose a 12-week intervention with therapeutic strength exercise in patients with colorectal cancer who are receiving chemotherapy treatment.	Other: 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.
Active Comparator: 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.	Other: Physical activity recommendations; They will be provided with a physical activity plan to be followed on a weekly basis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sex	It will be registered at the beginning of the study.	Baseline
Heighth	It will be registered at the beginning of the study in centimeters.	Baseline
Wellbeing	It will be evaluated through the the EORTC QLG Core Questionnaire (EORTC QOL-30) quality of life questionnaire in its specific version for colorectal cancer EORT QLQ-CR30. Scores can range from 0 (worst quality of life) to 100 (best quality of life), with higher values indicating better quality of life in the areas evaluated.	Baseline and immediately after the intervention
Body Mass Index	Obtained from the participant's weight and height.	Baseline and immediately after the intervention
Oxygen consumption	It will be evaluated through the 6-minute walk test.	Before and after the intervention
Anxiety and depression	They will be evaluated through the Hospital Anxiety and Depression Scale (HADS). Scores on the HADS can be interpreted as follows: Anxiety: 0-7: Absence of clinically significant anxiety. 8-10: Possible presence of clinically significant anxiety. 11 or more: Clinically significant anxiety. Depression: 0-7: Absence of clinically significant depression. 8-10: Possible presence of clinically significant depression. 11 or more: Clinically significant depression.	Baseline and immediately after the intervention
Fatigue	The Functional Assessment of Cancer Therapy (FACT-F) Questionnaire will be used. FACT-F scores are calculated by summing the scores of the different domains, where higher scores indicate better quality of life. The total score may vary depending on the scale used in the specific questionnaire, but generally ranges from 0 to 176 points.	Baseline and immediately after the intervention
Sleep quality	Will be evaluated through the Minimal Insomnia Symptom Scale (MISS). Each question is scored on a scale of 0 to 4, where 0 indicates that the symptom is not present and 4 indicates a very severe presence of the symptom. Therefore, the total score on the MISS can range from 0 to 12 points. Interpretations of the MISS scores may be as follows: 0-3 points: Absence or minimal presence of insomnia symptoms. 4-6 points: Mild insomnia symptoms. 7-9 points: Moderate insomnia symptoms. 10-12 points: Severe insomnia symptoms.	Baseline and immediately after the intervention

Collaborators and Investigators

• Sponsor: Juan Luis Sanchez Gonzalez

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 30, 2024
• First Submitted That Met QC Criteria: May 3, 2024
• First Posted (Actual): May 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 3, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Physiotherapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: OncoExercise

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Upon request by e-mail to the principal investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No