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OncologyNCT07307690

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

A study testing Exercise and Physical activity recommendations in people with Oncology and Chemotherapy-Induced Peripheral Neuropathy, run by University of Salamanca.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Exercise and Physical activity recommendations
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
1 Jan 2026to 1 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Carlos Martin Sanchez, PhD contact

+34923294500

carlos_ms@usal.es

About this study

Official title: Comparison of the Effectiveness of 8-week vs 12-week Physical Exercise Programmes in Patients With Colorectal Cancer

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.

Read more

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.

Read the detailed description
  1. Introduction Colon cancer is one of the leading causes of morbidity and mortality worldwide, with an increasing incidence in many developed countries. In Spain, it is one of the most common types of cancer, accounting for approximately 15% of all cancer cases diagnosed, with an incidence of around 41,000 new cases annually. The mortality associated with colon cancer is significant, although there have been notable improvements in five-year survival rates, which currently stand at around 65%, thanks to advances in treatments and early diagnosis. Early diagnosis is crucial and has been facilitated by screening programs such as colonoscopy and fecal occult blood tests, which allow the detection of precancerous lesions and early-stage cancer. Treatments for colon cancer include surgery, radiotherapy, immunotherapy, and notably, chemotherapy. Chemotherapy is especially relevant in adjuvant treatment to reduce the risk of postoperative recurrence and in metastatic disease to control tumor growth and prolong survival. Modern chemotherapeutic agents, combined with targeted and supportive therapies, have significantly improved treatment outcomes, providing patients with better recovery prospects and an enhanced quality of life during and after treatment.

Chemotherapy is a crucial treatment in the fight against colon cancer, but unfortunately, its impact is not limited solely to cancer cells. Chemotherapeutic agents, designed to target rapidly 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 sensations of tingling, numbness, pain, or weakness in the limbs. Chemotherapy-induced peripheral neuropathy can be especially challenging for patients with colon cancer, as it further worsens the quality of life during an already difficult period. The 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 battling 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 the regeneration of damaged peripheral nerves.

Additionally, exercise helps alleviate the pain and discomfort associated with neuropathy, thereby strengthening patients' functional capacity.

Scientific research has demonstrated that physical exercise has multiple benefits for cancer patients, beyond alleviating peripheral neuropathy. Various studies have indicated that regular physical activity can significantly improve immune function, which is crucial for patients undergoing treatments that weaken the immune system. Exercise helps increase the production and efficiency of immune cells, enhancing the body's ability to fight infections and potentially inhibiting the growth of cancer cells.

Furthermore, physical exercise has been associated with a reduction in cancer-related fatigue, one of the most debilitating symptoms experienced by patients during and after treatment. Fatigue can severely limit patients' ability to engage in daily activities and reduce their quality of life. Research has shown that structured exercise programs, including aerobic and resistance activities, can diminish the sensation of fatigue and improve energy levels and mood, allowing patients to lead more active and fulfilling lives.

Physical activity also plays a vital role in weight management and body composition, important factors for cancer survival and recovery. Obesity and overweight are associated with poorer prognosis in many types of cancer, including colon cancer. Regular exercise helps maintain a healthy weight, reduce body fat, and improve muscle mass, which not only contributes to a better quality of life but can also reduce the risk of cancer recurrence and improve overall treatment outcomes. Scientific evidence strongly supports the inclusion of physical exercise as an integral part of the treatment plan for cancer patients.

It is essential to highlight that any exercise plan should be tailored to the individual capabilities of each patient, and medical supervision is crucial. 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 recovery journey.

It is of vital importance to conduct research on the implementation of physical exercise programs in patients with colon cancer to control all the previously mentioned symptoms, such as peripheral neuropathy, fatigue, decreased immune function, and weight management.

These investigations should focus on developing personalized and safe exercise protocols that can be effectively integrated into standard oncological treatment. By generating robust evidence on the benefits and best practices for including physical exercise in the management of colon cancer, patient quality of life can be significantly improved, treatment outcomes optimized, and the incidence of debilitating side effects reduced.

Moreover, these studies can provide crucial data to guide healthcare professionals in prescribing specific exercise programs, ensuring that patients receive evidence-based interventions that maximize their physical and emotional well-being throughout the recovery process.

Therefore, this project sets the following study objectives. As the main objective, this study aims to evaluate and compare the effectiveness of an 8-week versus a 12-week exercise programme in improving chemotherapy-induced peripheral neuropathy in patients with colorectal cancer. And as secondary objectives, the following:

  1. To assess the impact of a strength exercise program on quality of life in patients with colorectal cancer undergoing chemotherapy treatment.
  2. To evaluate the impact of a strength exercise program on body mass index in patients with colorectal cancer undergoing chemotherapy treatment.
  3. To evaluate the impact of a strength exercise program on maximum oxygen consumption in patients with colorectal cancer undergoing chemotherapy treatment.
  4. To evaluate the impact of a strength exercise program on anxiety and depression in patients with colorectal cancer undergoing chemotherapy treatment.
  5. To evaluate the impact of a strength exercise program on fatigue in patients with colorectal cancer undergoing chemotherapy treatment.
  6. To evaluate the impact of a strength exercise program on sleep quality in patients with colorectal cancer undergoing chemotherapy treatment.

Study Design and Setting A double-blind randomized controlled trial was conducted at the Faculty of Nursing and Physiotherapy, University of Salamanca (Spain), following the Consolidated Standards of Reporting Trials (CONSORT) Statement. The current treatment protocol is described according to the recommendations of SPIRIT. The protocol for this trial received approval from the Ethics Committee of the University of Salamanca (record number 1209) and was conducted in accordance with the Declaration of Helsinki. The clinical trial was registered in ClinicalTrials.gov (registration number NCT06404359).

Participants diagnosed with colorectal cancer undergoing adjuvant chemotherapy treatment were recruited from the outpatient clinics of the Day Oncology Hospital at the University Assistance Complex of Salamanca and from the Asociación Española Contra el Cáncer (AECC).

Being tested
Exercise, Physical activity recommendations
Keywords
Exercise, Cancer, Colorectal cancer, wellbeing, Mental health
Medical subject headings
Neoplasms, Motor Activity, Colorectal Neoplasms, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseOther

    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 recommendationsOther

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

Study groups in NCT07307690
Study groupRoleWhat they receive
Exercise groupExperimentalThe investigators propose a 8 vs 12-week intervention with therapeutic strength exercise in patients with colorectal cancer who are receiving chemotherapy treatment.
Receives: Other: Exercise; Other: Physical activity recommendations
Control groupExperimentalThey 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.
Receives: Other: Physical activity recommendations

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and immediately after the intervention

Secondary outcomes (4)
  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.

    Measured: Baseline and immediately after the intervention

  2. Body Mass Index

    Obtained from the participant's weight and height.

    Measured: 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.

    Measured: 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.

    Measured: Baseline and immediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2025
  2. Study start1 Jan 2026 (estimated)
  3. Primary completion1 May 2026 (estimated)
  4. Study completion1 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07307690
Sponsor's protocol ID
ComparisonCCRDic2025
Status last verified
Dec 2025
First submitted
13 Dec 2025
Last updated
6 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Upon request by e-mail to the principal investigator

Publications

  • 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.

    PubMed 39124745
  • Martin-Sanchez C, Polo-Ferrero L, Mendez-Sanchez R, Puente-Gonzalez AS, Manso-Hierro T, Jose-Fernandez-Rodriguez E, Arroyo-Garrapucho N, Lopez-Mateos Y, Espinal-Matos SL, Fonseca-Sanchez E, Medina Hernandez L, Fuentes M, Sanchez-Gonzalez JL. 8- versus 12-week supervised resistance training with home-based physical activity during colorectal cancer treatment: a pilot randomized dose-comparison trial. BMC Cancer. 2026 May 28. doi: 10.1186/s12885-026-16245-2. Online ahead of print.

    PubMed 42210209

Questions about this trial

What is this clinical trial studying?

A study testing Exercise and Physical activity recommendations in people with Oncology and Chemotherapy-Induced Peripheral Neuropathy, run by University of Salamanca.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Carlos Martin Sanchez, PhD (+34923294500, carlos_ms@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chemotherapy-induced neuropathy (time frame: Baseline and immediately after the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07307690, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.

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