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

Oncology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06404359
• Other study ID #: OncoExercise
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: University of Salamanca
• Contact: Juan Luis Sánchez González, Phd
• Phone: 923294500
• Email: juanluissanchez[@]usal.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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,...).

Related Conditions & MeSH terms

• Chemotherapy-induced Peripheral Neuropathy
• Oncology
• Peripheral Nervous System Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Juan Luis Sanchez Gonzalez

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Body Mass Index	Obtained from the participant's weight and height.	Baseline and immediately after the intervention
Secondary	Oxygen consumption	It will be evaluated through the 6-minute walk test.	Before and after the intervention
Secondary	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
Secondary	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
Secondary	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
Secondary	Sex	It will be registered at the beginning of the study.	Baseline
Secondary	Heighth	It will be registered at the beginning of the study in centimeters.	Baseline