Cancer Patients in Different StagesNCT05078216
How to Carry on an Effective Community Program of Exercice-oncology.
An observational study of Cancer Patients in Different Stages, run by Asociación Española contra el Cáncer at 1 site in Spain.
Trial summary
Exercise-oncology is an emerging area, but exist a lack of information about an effective methodology to establish counseling programs long-lasting and not based on research objectives. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Patients in Different Stages
- What is being tested?
- Physical exercise intervention
- How many people
- 405 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2018to 13 Mar 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Three different type of cancer patients were included: 1. patients that recently finished their treatments but still presented secondary effects (patients under hormonotherapy are included here); 2. patients under chemotherapy, radiotherapy or target therapy treatments; 3. patients with advanced or metastatic cancer
Who may be able to join
- Being a cancer patient
- Being over 18 years
- Having an Eastern Cooperative Oncology Group (ECOG)≤1,
- Being e able to walk 500 meters without resting
- Feeling or presenting any physical side effect related to cancer treatments, like weakness, fatigue, change in body composition, and/or physical pain, without significant clinical implications
Who cannot join
- Presenting any physical or psychological disability
- Having an ejection fraction below 50%
- Having any American Thoracic Society recommendations to not develop a Cardio Pulmonary Exercise Test
- Present joint limitations with need of rehabilitation exercise, grade 1-2 lymphedema
- Presenting active bone metastasis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: How to Carry on an Effective Community Program of Exercice-oncology. A Pilot Experience
Exercise-oncology is an emerging area, but exist a lack of information about an effective methodology to establish counseling programs long-lasting and not based on research objectives. This observational study objective was to evaluate the feasibility and effective exercise-oncology community intervention in a real patients sample.
Read the detailed description
The application of exercise-oncology in a real stage is a growing field, having a crucial role throughout the illness. In this sense, exercise has been proved as an effective intervention to prevent reductions in fitness and functional capacity, muscle mass and strength loss; and risings of fat mass, fatigue, anxiety and quality of sleep [1, 2]. Moreover, there has been increasing evidence proving the positive effects of exercise training on some prognostic biomarkers related to cancer such as reductions in sex hormone levels, [3, 4] insulin levels, [5] inflammation levels [6-9] and rising the immune function [10]. The balance of these biomarkers has been directly linked to an improvement in survival in active patients of breast, colon and prostate cancer.
Despite all these benefits, patients and clinical specialists present a reduced adherence to clinical or community exercise-oncology programs, specially when patients are under oncology treatments. In order to provide support, the multidisciplinary roundtable organised by the American College of Sport Medicine (ACSM) published their professional guidelines in 2010 and reviewed in 2018, describing not only the exercise benefits but also the exercise interventions effectiveness [11, 12]. In addition, other institutions, such as the American Cancer Society (ACSM) or the Canadian Society for Exercise Physiology (CSEP), have highlighted the same idea, publishing general recommendations for cancer patients and cancer survivors to support clinicians and promote exercise adherence [13, 14].
However, in Spain, there is still a tremendous lack of these kind of programs. This is really surprising, even more if one considers the statement of the Sociedad Española de Oncología Médica (SEOM) which enlightened the necessity to develop effective community exercise-oncology interventions to support oncologists and patients by ensuring the performance of exercise in safeness conditions as well as a long-lasting adherence to physical exercise [15].
For this reason, the main objective of this pilot experience was to propose a feasible model for the implementation of an exercise-oncology program into specific community programs, providing specific support to clinicians. An effective exercise dose-response, to reduce side effects, as well as the safeness and exercise adherence after the program in cancer patients in different stages, were also evaluated.
- Conditions
- Cancer Patients in Different Stages
- Being tested
- Physical exercise intervention
- Keywords
- exercise-oncology,, physical activity intervention, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exercise interventionOther
12-week supervised intervention, 90 minutes sessions twice per week All sessions had the same structure: 10 min of warm-up at 60-70% maximal heart rate (MHR), followed by 60-70 minutes of specific training and 10 minutes of stretching exercises. At least, 20% of the total session time was based on cardiovascular work over 70% of the maximum heart rate (MHR).
Fitness work in the first eight sessions was planned following 30 min of time on cardiovascular exercise 55 min on work out in low to moderate intensity. In the next eight sessions, the time spent on cardiovascular work was slightly increased to 35 min, with 50 min focused on work out, combining moderate to high-intensity sessions. The last eight sessions presented the same structure as the first ones but combining moderate to high intensity.
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients | The exercise program consisted of a 12-week supervised intervention, with twice per week sessions of 90 minutes, and was developed in a friendly and close environment, which promoted social interaction between participants. Apart from the twice-weekly supervised sessions, as early as the fifth week, one or two individualized home-based sessions were established for each patient in order to achieve his/her specific objectives with the help of any required supporting material such as documents and video references with exercise examples.
All sessions had the same structure: 10 min of warm-up at 60-70% maximal heart rate (MHR), followed by 60-70 minutes of specific training and 10 minutes of stretching exercises. At least, 20% of the total session time was based on cardiovascular work over 70% of the maximum heart rate (MHR) Receives: Other: Physical exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of an exercise-oncology program
to propose a feasible model for the implementation of an exercise-oncology program into specific community programs, providing specific support to clinicians.
Measured: 12 weeks
Secondary outcomes (1)
Effective dose-response, safeness and adherence
To evaluate an effective exercise dose-response to reduce side effects, as well as the safeness and exercise adherence after the program
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start1 Sep 2018
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cancer Patients in Different StagesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociación Española contra el Cáncer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LUCÍA GIL HERRERO, Asociación Española contra el Cáncer
- Investigators
- Soraya Casla Barrio, Phd, Study director, Asociación Española contra el Cáncer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078216
- Sponsor's protocol ID
- CEI PI 23_2021-v4
- Status last verified
- Oct 2021
- First submitted
- 12 Oct 2021
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferioli M, Zauli G, Martelli AM, Vitale M, McCubrey JA, Ultimo S, Capitani S, Neri LM. Impact of physical exercise in cancer survivors during and after antineoplastic treatments. Oncotarget. 2018 Feb 8;9(17):14005-14034. doi: 10.18632/oncotarget.24456. eCollection 2018 Mar 2.
PubMed 29568412Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvao DA, Pinto BM, Irwin ML, Wolin KY, Segal RJ, Lucia A, Schneider CM, von Gruenigen VE, Schwartz AL; American College of Sports Medicine. American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 2010 Jul;42(7):1409-26. doi: 10.1249/MSS.0b013e3181e0c112.
PubMed 20559064Campbell KL, Winters-Stone KM, Wiskemann J, May AM, Schwartz AL, Courneya KS, Zucker DS, Matthews CE, Ligibel JA, Gerber LH, Morris GS, Patel AV, Hue TF, Perna FM, Schmitz KH. Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable. Med Sci Sports Exerc. 2019 Nov;51(11):2375-2390. doi: 10.1249/MSS.0000000000002116.
PubMed 31626055Schmitz KH, Campbell AM, Stuiver MM, Pinto BM, Schwartz AL, Morris GS, Ligibel JA, Cheville A, Galvao DA, Alfano CM, Patel AV, Hue T, Gerber LH, Sallis R, Gusani NJ, Stout NL, Chan L, Flowers F, Doyle C, Helmrich S, Bain W, Sokolof J, Winters-Stone KM, Campbell KL, Matthews CE. Exercise is medicine in oncology: Engaging clinicians to help patients move through cancer. CA Cancer J Clin. 2019 Nov;69(6):468-484. doi: 10.3322/caac.21579. Epub 2019 Oct 16.
PubMed 31617590Pollan M, Casla-Barrio S, Alfaro J, Esteban C, Segui-Palmer MA, Lucia A, Martin M. Exercise and cancer: a position statement from the Spanish Society of Medical Oncology. Clin Transl Oncol. 2020 Oct;22(10):1710-1729. doi: 10.1007/s12094-020-02312-y. Epub 2020 Feb 13.
PubMed 32052383GilHerrero L, Courneya KS, McNeely ML, Castellanos M, Gonzalez Marquez AI, Pollan M, Casla-Barrio S. Effects of a Clinical Exercise Program on Health-Related Fitness and Quality of Life in Spanish Cancer Patients Receiving Adjuvant Therapy. Integr Cancer Ther. 2022 Jan-Dec;21:15347354221141715. doi: 10.1177/15347354221141715.
PubMed 36565156
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How to Carry on an Effective Community Program of Exercice-oncology. A Pilot Experience
- ClinicalTrials.gov ID
- NCT05078216
- Acronym / sponsor ID
- CEI PI 23_2021-v4
- Conditions
- Cancer Patients in Different Stages
- Keywords
- exercise-oncology,, physical activity intervention, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Asociación Española contra el CáncerUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 14 Oct 2021 (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.
Exercise-oncology is an emerging area, but exist a lack of information about an effective methodology to establish counseling programs long-lasting and not based on research objectives. This observational study objective was to evaluate the feasibility and effective exercise-oncology community intervention in a real patients sample.
Detailed description
The application of exercise-oncology in a real stage is a growing field, having a crucial role throughout the illness. In this sense, exercise has been proved as an effective intervention to prevent reductions in fitness and functional capacity, muscle mass and strength loss; and risings of fat mass, fatigue, anxiety and quality of sleep [1, 2]. Moreover, there has been increasing evidence proving the positive effects of exercise training on some prognostic biomarkers related to cancer such as reductions in sex hormone levels, [3, 4] insulin levels, [5] inflammation levels [6-9] and rising the immune function [10]. The balance of these biomarkers has been directly linked to an improvement in survival in active patients of breast, colon and prostate cancer.
Despite all these benefits, patients and clinical specialists present a reduced adherence to clinical or community exercise-oncology programs, specially when patients are under oncology treatments. In order to provide support, the multidisciplinary roundtable organised by the American College of Sport Medicine (ACSM) published their professional guidelines in 2010 and reviewed in 2018, describing not only the exercise benefits but also the exercise interventions effectiveness [11, 12]. In addition, other institutions, such as the American Cancer Society (ACSM) or the Canadian Society for Exercise Physiology (CSEP), have highlighted the same idea, publishing general recommendations for cancer patients and cancer survivors to support clinicians and promote exercise adherence [13, 14].
However, in Spain, there is still a tremendous lack of these kind of programs. This is really surprising, even more if one considers the statement of the Sociedad Española de Oncología Médica (SEOM) which enlightened the necessity to develop effective community exercise-oncology interventions to support oncologists and patients by ensuring the performance of exercise in safeness conditions as well as a long-lasting adherence to physical exercise [15].
For this reason, the main objective of this pilot experience was to propose a feasible model for the implementation of an exercise-oncology program into specific community programs, providing specific support to clinicians. An effective exercise dose-response, to reduce side effects, as well as the safeness and exercise adherence after the program in cancer patients in different stages, were also evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer patients | – | Other: Physical exercise interventionThe exercise program consisted of a 12-week supervised intervention, with twice per week sessions of 90 minutes, and was developed in a friendly and close environment, which promoted social interaction between participants. Apart from the twice-weekly supervised sessions, as early as the fifth week, one or two individualized home-based sessions were established for each patient in order to achieve his/her specific objectives with the help of any required supporting material such as documents and video references with exercise examples. All sessions had the same structure: 10 min of warm-up at 60-70% maximal heart rate (MHR), followed by 60-70 minutes of specific training and 10 minutes of stretching exercises. At least, 20% of the total session time was based on cardiovascular work over 70% of the maximum heart rate (MHR) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Three different type of cancer patients were included: 1. patients that recently finished their treatments but still presented secondary effects (patients under hormonotherapy are included here); 2. patients under chemotherapy, radiotherapy or target therapy treatments; 3. patients with advanced or metastatic cancer
Key inclusion criteria (5 listed)
- Being a cancer patient
- Being over 18 years
- Having an Eastern Cooperative Oncology Group (ECOG)≤1,
- Being e able to walk 500 meters without resting
- Feeling or presenting any physical side effect related to cancer treatments, like weakness, fatigue, change in body composition, and/or physical pain, without significant clinical implications
Key exclusion criteria (5 listed)
- Presenting any physical or psychological disability
- Having an ejection fraction below 50%
- Having any American Thoracic Society recommendations to not develop a Cardio Pulmonary Exercise Test
- Present joint limitations with need of rehabilitation exercise, grade 1-2 lymphedema
- Presenting active bone metastasis.
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 |
|---|---|---|
| Physical exercise intervention12-week supervised intervention, 90 minutes sessions twice per week All sessions had the same structure: 10 min of warm-up at 60-70% maximal heart rate (MHR), followed by 60-70 minutes of specific training and 10 minutes of stretching exercises. At least, 20% of the total session time was based on cardiovascular work over 70% of the maximum heart rate (MHR). Fitness work in the first eight sessions was planned following 30 min of time on cardiovascular exercise 55 min on work out in low to moderate intensity. In the next eight sessions, the time spent on cardiovascular work was slightly increased to 35 min, with 50 min focused on work out, combining moderate to high-intensity sessions. The last eight sessions presented the same structure as the first ones but combining moderate to high intensity. | Other | Cancer patients |
Primary outcome
Feasibility of an exercise-oncology program
Time frame: 12 weeks
to propose a feasible model for the implementation of an exercise-oncology program into specific community programs, providing specific support to clinicians.
1 secondary outcome
Effective dose-response, safeness and adherence
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Results publication: PubMed 29568412Ferioli M, Zauli G, Martelli AM, Vitale M, McCubrey JA, Ultimo S, Capitani S, Neri LM. Impact of physical exercise in cancer survivors during and after antineoplastic treatments. Oncotarget. 2018 Feb 8;9(17):14005-14034. doi: 10.18632/oncotarget.24456. eCollection 2018 Mar 2.
- Results publication: PubMed 20559064Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvao DA, Pinto BM, Irwin ML, Wolin KY, Segal RJ, Lucia A, Schneider CM, von Gruenigen VE, Schwartz AL; American College of Sports Medicine. American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 2010 Jul;42(7):1409-26. doi: 10.1249/MSS.0b013e3181e0c112.
- Results publication: PubMed 31626055Campbell KL, Winters-Stone KM, Wiskemann J, May AM, Schwartz AL, Courneya KS, Zucker DS, Matthews CE, Ligibel JA, Gerber LH, Morris GS, Patel AV, Hue TF, Perna FM, Schmitz KH. Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable. Med Sci Sports Exerc. 2019 Nov;51(11):2375-2390. doi: 10.1249/MSS.0000000000002116.
- Results publication: PubMed 31617590Schmitz KH, Campbell AM, Stuiver MM, Pinto BM, Schwartz AL, Morris GS, Ligibel JA, Cheville A, Galvao DA, Alfano CM, Patel AV, Hue T, Gerber LH, Sallis R, Gusani NJ, Stout NL, Chan L, Flowers F, Doyle C, Helmrich S, Bain W, Sokolof J, Winters-Stone KM, Campbell KL, Matthews CE. Exercise is medicine in oncology: Engaging clinicians to help patients move through cancer. CA Cancer J Clin. 2019 Nov;69(6):468-484. doi: 10.3322/caac.21579. Epub 2019 Oct 16.
- Results publication: PubMed 32052383Pollan M, Casla-Barrio S, Alfaro J, Esteban C, Segui-Palmer MA, Lucia A, Martin M. Exercise and cancer: a position statement from the Spanish Society of Medical Oncology. Clin Transl Oncol. 2020 Oct;22(10):1710-1729. doi: 10.1007/s12094-020-02312-y. Epub 2020 Feb 13.
- Derived from this study: PubMed 36565156GilHerrero L, Courneya KS, McNeely ML, Castellanos M, Gonzalez Marquez AI, Pollan M, Casla-Barrio S. Effects of a Clinical Exercise Program on Health-Related Fitness and Quality of Life in Spanish Cancer Patients Receiving Adjuvant Therapy. Integr Cancer Ther. 2022 Jan-Dec;21:15347354221141715. doi: 10.1177/15347354221141715.
- Individual participant dataSharing planned: No
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.
Soraya Casla Barrio, Phd study director
Asociación Española contra el Cáncer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Patients in Different Stages, run by Asociación Española contra el Cáncer at 1 site in Spain.
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 5 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: finished, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of an exercise-oncology program (time frame: 12 weeks). 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 NCT05078216, which also lists 6 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 14 Oct 2021; AzTrials last refreshed its copy on 6 Nov 2026.