8 Weeks vs 12 Weeks Physical Exercise Programmes in Colorectal Cancer Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Salamanca

About this trial

Chemotherapy is a cornerstone in the treatment of colon cancer; however, its effects extend beyond malignant cells. Because chemotherapeutic agents target rapidly dividing cells, they can also damage healthy tissues, resulting in a range of adverse effects. Among the most prevalent is peripheral neuropathy, a disorder of the peripheral nervous system characterized by symptoms such as tingling, numbness, pain, and weakness in the extremities.

Chemotherapy-induced peripheral neuropathy poses a significant challenge for patients with colon cancer, as it further compromises quality of life during an already demanding phase of treatment. Damage to sensory and motor nerves interferes with the ability to perform daily activities and diminishes physical capacity, thereby intensifying both the physical and psychological burden associated with the disease.

Nevertheless, certain interventions may help mitigate these negative effects, with physical exercise emerging as a particularly promising strategy. Although it may appear counterintuitive, regular physical activity has been shown to exert beneficial effects on peripheral neuropathy. Exercise enhances blood circulation, supports the regeneration of damaged peripheral nerves, and helps reduce neuropathic pain and discomfort, ultimately improving functional performance.

It is important to emphasize that exercise interventions should be individually tailored and conducted under appropriate medical supervision. Consequently, the integration of chemotherapy with a carefully designed exercise program represents a comprehensive approach to managing both the disease and its treatment-related side effects, contributing to an improved quality of life for patients with colon cancer throughout their recovery process.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise

    Other intervention

    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

    Other intervention

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Exercise groupExperimental treatment 2 interventions
Group B: Control groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and immediately after the intervention

Secondary outcomes

1

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.

Time frame
Baseline and immediately after the intervention
2

Body Mass Index

Obtained from the participant's weight and height.

Time frame
Baseline and immediately after the intervention
3

Mental health

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.

Time frame
Baseline and immediately after the intervention
4

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.

Time frame
Baseline and immediately after the intervention

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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