OncologyNCT06404359
Effects of a Strength Physical Exercise Program in Colorectal Cancer Patients Undergoing Chemotherapy Treatment
A study testing Exercise and Physical activity recommendations in people with Oncology and Chemotherapy-induced Peripheral Neuropathy, run by Juan Luis Sanchez Gonzalez.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Oncology, Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Exercise and Physical activity recommendations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 85 years
- 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.
About this study
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.
Read more
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.
- Being tested
- Exercise, Physical activity recommendations
- Keywords
- Exercise, Physiotherapy
- Medical subject headings
- Neoplasms, Motor Activity
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 group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | The investigators propose a 12-week intervention with therapeutic strength exercise in patients with colorectal cancer who are receiving chemotherapy treatment. Receives: Other: Exercise |
| Control group | Active comparator | 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. Receives: Other: Physical activity recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. Item 20 rates male impotence
Measured: Baseline and immediately after the intervention
Secondary outcomes (8)
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
Body Mass Index
Obtained from the participant's weight and height.
Measured: Baseline and immediately after the intervention
Oxygen consumption
It will be evaluated through the 6-minute walk test.
Measured: Before and after the intervention
Anxiety and depression
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
Fatigue
The 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.
Measured: Baseline and immediately after the intervention
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
Sex
It will be registered at the beginning of the study.
Measured: Baseline
Heighth
It will be registered at the beginning of the study in centimeters.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juan Luis Sanchez Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Juan Luis Sanchez Gonzalez, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404359
- Sponsor's protocol ID
- OncoExercise
- Status last verified
- May 2024
- First submitted
- 30 Apr 2024
- Last updated
- 8 May 2024
- 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, Fonseca-Sanchez E, Mateos YL, Espinal-Matos S, Martin-Vallejo J, Garcia-Martin A, Cruz-Hernandez JJ, Gonzalez JLS. Effects of a resistance training program on chemotherapy-induced peripheral neuropathy, cancer-related fatigue, muscle strength and physical activity in colorectal cancer patients undergoing chemotherapy: a pilot randomized controlled trial. Clin Transl Oncol. 2026 Apr 30. doi: 10.1007/s12094-026-04371-z. Online ahead of print.
PubMed 42060079
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Strength Physical Exercise Program in Colorectal Cancer Patients Undergoing Chemotherapy Treatment
- ClinicalTrials.gov ID
- NCT06404359
- Acronym / sponsor ID
- OncoExercise
- Keywords
- Exercise, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Juan Luis Sanchez GonzalezUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: ExerciseThe investigators propose a 12-week intervention with therapeutic strength exercise in patients with colorectal cancer who are receiving chemotherapy treatment. |
| Control group | Active comparator | Other: Physical activity recommendationsThey 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Present contraindication/s for physical exercise (musculoskeletal diseases, severe cardiovascular disease, bone metastases,...).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseThere 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. | Other | Exercise group |
| Physical activity recommendationsThey will be provided with a physical activity plan to be followed on a weekly basis. | Other | Control group |
Primary outcome
Chemotherapy-induced neuropathy
Time frame: Baseline and immediately after the intervention
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. Item 20 rates male impotence
8 secondary outcomes
Wellbeing
Time frame: Baseline and immediately after the intervention
Body Mass Index
Time frame: Baseline and immediately after the intervention
Oxygen consumption
Time frame: Before and after the intervention
Anxiety and depression
Time frame: Baseline and immediately after the intervention
Fatigue
Time frame: Baseline and immediately after the intervention
Sleep quality
Time frame: Baseline and immediately after the intervention
Sex
Time frame: Baseline
Heighth
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Derived from this study: PubMed 42060079Martin-Sanchez C, Fernandez-Rodriguez EJ, Fonseca-Sanchez E, Mateos YL, Espinal-Matos S, Martin-Vallejo J, Garcia-Martin A, Cruz-Hernandez JJ, Gonzalez JLS. Effects of a resistance training program on chemotherapy-induced peripheral neuropathy, cancer-related fatigue, muscle strength and physical activity in colorectal cancer patients undergoing chemotherapy: a pilot randomized controlled trial. Clin Transl Oncol. 2026 Apr 30. doi: 10.1007/s12094-026-04371-z. Online ahead of print.
- Individual participant dataSharing planned: Undecided. Upon request by e-mail to the principal investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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 Juan Luis Sanchez Gonzalez.
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: status not confirmed, as of the sponsor's last update on 8 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan Luis Sánchez González, Phd (923294500 ext. 3167, juanluissanchez@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 NCT06404359, which also lists 1 linked publication.
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 8 May 2024.