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Trial Title:
Effects of a Strength Physical Exercise Program in Colorectal Cancer Patients Undergoing Chemotherapy Treatment
NCT ID:
NCT06404359
Condition:
Oncology
Chemotherapy-induced Peripheral Neuropathy
Conditions: Official terms:
Peripheral Nervous System Diseases
Conditions: Keywords:
Exercise
Physiotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Double (Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
Exercise
Description:
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.
Arm group label:
Exercise group
Intervention type:
Other
Intervention name:
Physical activity recommendations
Description:
They will be provided with a physical activity plan to be followed on a weekly basis.
Arm group label:
Control group
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.
Criteria for 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.
- 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,...).
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Start date:
June 1, 2024
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Juan Luis Sanchez Gonzalez
Agency class:
Other
Source:
University of Salamanca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06404359
