Clinical trial NCT05078216: How to Carry on an Effective Community Program of Exercice-oncology.
Official title: How to Carry on an Effective Community Program of Exercice-oncology. A Pilot Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer Patients in Different Stages
Keywords: exercise-oncology,
physical activity intervention
quality of life
Lead sponsor: Asociación Española contra el Cáncer
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 405
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Feasibility of an exercise-oncology program
timeFrame: 12 weeks
Secondary outcomes:
measure: Effective dose-response, safeness and adherence
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Spanish Cancer Association
Study officials:
affiliation: Asociación Española contra el Cáncer
name: Soraya Casla Barrio, Phd
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Schmitz 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.
citation: Campbell 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.
citation: Schmitz 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.
citation: Pollan 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.