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

NCT07307690 | Not Yet Recruiting

• 1 other identifier: ComparisonCCRDic2025
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Oncology; Chemotherapy-Induced Peripheral Neuropathy

Keywords

Exercise; Cancer; Colorectal cancer; wellbeing; Mental health

Outcome Measures

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.

  Baseline and immediately after the intervention

Secondary Outcomes (4)

• Wellbeing

  Baseline and immediately after the intervention

• Body Mass Index

  Baseline and immediately after the intervention

• Mental health

  Baseline and immediately after the intervention

• Sleep quality

  Baseline and immediately after the intervention

Study Arms (2)

Exercise group

EXPERIMENTAL

The investigators propose a 8 vs 12-week intervention with therapeutic strength exercise in patients with colorectal cancer who are receiving chemotherapy treatment.

Other: Exercise; Other: Physical activity recommendations

Control group

EXPERIMENTAL

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

Interventions

Exercise OTHER

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.

Exercise group

Physical activity recommendations OTHER

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

Control group; Exercise group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Voluntary participation in the study.

You may not qualify if:

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

Sponsors & Collaborators

• University of Salamanca: lead

Related Publications (1)

• Martin-Sanchez C, Fernandez-Rodriguez EJ, Lopez-Mateos Y, Garcia-Martin A, Fonseca-Sanchez E, Sanchez-Gonzalez JL. Effects of a Resistance Exercise Program in Patients with Colorectal Cancer Undergoing Chemotherapy Treatment: A Randomized Controlled Trial Study Protocol. J Clin Med. 2024 Jul 31;13(15):4478. doi: 10.3390/jcm13154478.

  PMID: 39124745 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Motor Activity; Colorectal Neoplasms; Psychological Well-Being

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Carlos Martin Sanchez, PhD

CONTACT

+34923294500; carlos_ms@usal.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: December 13, 2025
• First Posted: December 29, 2025
• Study Start: January 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-12