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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06404359
Enrollment
40
Registered
2024-05-08
Start date
2024-06-01
Completion date
2024-12-31
Last updated
2024-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oncology, Chemotherapy-induced Peripheral Neuropathy

Keywords

Exercise, Physiotherapy

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.

Interventions

OTHERExercise

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.

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

Sponsors

Juan Luis Sanchez Gonzalez
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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,...).

Design outcomes

Primary

MeasureTime frameDescription
Chemotherapy-induced neuropathyBaseline and immediately after the interventionThe 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

Secondary

MeasureTime frameDescription
Body Mass IndexBaseline and immediately after the interventionObtained from the participant's weight and height.
Oxygen consumptionBefore and after the interventionIt will be evaluated through the 6-minute walk test.
Anxiety and depressionBaseline and immediately after the interventionThey 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.
WellbeingBaseline and immediately after the interventionIt 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.
Sleep qualityBaseline and immediately after the interventionWill 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.
SexBaselineIt will be registered at the beginning of the study.
HeighthBaselineIt will be registered at the beginning of the study in centimeters.
FatigueBaseline and immediately after the interventionThe 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.

Contacts

Primary ContactJuan Luis Sánchez González, Phd
juanluissanchez@usal.es923294500
Backup ContactCarlos Martín Sánchez, Phd
carlos_ms@usal.es923294500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026