Clinical trial NCT03787966: Attenuating Cancer Treatment-related Toxicity in Oncology Patients With a Tailored Physical Exercise Program
Official title: Attenuating Cancer Treatment-related Toxicity in Oncology Patients With a Tailored Physical Exercise Program: Study Protocol of the ATOPE Trial in Women Recently Diagnosed With Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Neoplasms
Keywords: Breast neoplasm
Breast cancer
therapeutic exercise
cardiotoxicity
muscle toxicity
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2018-12-27
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine if therapeutic exercise before anticancer treatment will mitigate the onset or extent of cardiotoxicity comparing to therapeutic exercise performed during anticancer treatment.

Detailed description: The positive relationship between physical exercise and cancer is widely justified in the literature, but an emerging research line warns of its capacity to improve the effectiveness and reduce the toxicity of cancer treatment (responsible for the appearance of side effects and comorbidities), that overload the health care system. To date, there is a lack of knowledge in different subjects: the possibility of implementing individualized exercise programs in clinical environment to mitigate the side effects of cancer treatment; the best moment in natural history of the disease to perform therapeutic exercise; and a tailored dose of exercise that maximizes its benefits.

In this context, the present study will evaluate the effects of a therapeutic exercise program conducted previously at the beginning of the cancer treatment, in the treatments' toxicity against the same program conducted during cancer treatments in women with breast cancer, and its positive effects on both clinical and biological variables and their possible impact on disease-free survival.

This study will be conducted in 3 phases with 110 participants in total: phase 1: a pilot study be carried out to check the feasibility of the proposed physical exercise program; phase 2: to test the effectiveness of the program ATOPE performed prior to surgical medical treatment against the same made during treatment, with a randomized controlled clinical trial; and phase 3: in which it will be integrated into the health service and a larger project will be requested at the international level.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Breast cancer diagnosis I-III stage
* On the waiting list to anticancer medical treatment (at least surgery, chemotherapy and radiotherapy.
* If they meet other criteria which predisposes to higher toxicity.
* Have signed informed consent.
* Have medical clearance for participation.

Exclusion Criteria:

* Patient underwent previous cancer treatments.
* Patients were previously diagnosed with cancer.
* Pregnant patients.
* Patients performing other type of therapeutic exercise at diagnosis time with an intake \>or = to 150 moderate-intensity or 75 min of vigorous-intensity a day.
* Therapeutic exercise practice not recommended because psychiatric or cognitive disorders or cute or chronic condition that prevents exercise (advanced lung disease, oxygen requirement, stenosis \>70%, metastasis etc.).

Primary outcomes:
measure: Left ventricular ejection fraction
timeFrame: Participants will be followed over 12 months
Secondary outcomes:
measure: Cardiovascular events
timeFrame: Participants will be followed over 12 months
measure: Resting heart rate
timeFrame: Participants will be followed over 12 months
measure: Heart Rate variability
timeFrame: Participants will be followed over 12 months
measure: Muscle loss
timeFrame: Participants will be followed over 12 months
measure: Quality of life with the Quality of Life Questionnaire (QLQ)-C30
timeFrame: Participants will be followed over 12 months
measure: Quality of life with the Quality of life Questionnaire (QLQ- BR23) a specific module.
timeFrame: Participants will be followed over 12 months but will not be assessed in baseline
measure: Chemotherapy regimen
timeFrame: Participants will be followed over 12 months
measure: Chemotherapy doses modifications
timeFrame: Participants will be followed over 12 months
measure: Early session termination.
timeFrame: Participants will be followed over 12 months
measure: Missing bouts due to adverse effects of chemotherapy
timeFrame: Participants will be followed over 12 months
measure: Number of hospitalizations.
timeFrame: Participants will be followed over 12 months
measure: Therapeutic exercise bout modification
timeFrame: Participants will be followed over 12 months
measure: Time to treatment failure
timeFrame: Participants will be followed over 12 months
measure: Program adverse effects reported by the participants.
timeFrame: Participants will be followed over 12 months
measure: Functional capacity
timeFrame: Participants will be followed over 12 months
measure: Handgrip strength
timeFrame: Participants will be followed over 12 months
measure: Shoulder strength
timeFrame: Participants will be followed over 12 months
measure: Lower limb strength
timeFrame: Participants will be followed over 12 months
measure: Abdominal strength
timeFrame: Participants will be followed over 12 months
measure: Flexibility
timeFrame: Participants will be followed over 12 months
measure: Waist and hip circumferences
timeFrame: Participants will be followed over 12 months
measure: Body composition
timeFrame: Participants will be followed over 12 months
measure: Oxidative stress
timeFrame: Participants will be followed over 12 months
measure: Oxidative stress
timeFrame: Participants will be followed over 12 months
measure: Inmune function
timeFrame: Participants will be followed over 12 months
measure: inflammation
timeFrame: Participants will be followed over 12 months
measure: inflammation
timeFrame: Participants will be followed over 12 months
measure: inflammation
timeFrame: Participants will be followed over 12 months
measure: inflammation
timeFrame: Participants will be followed over 12 months
Other outcomes:
Locations:
city: Granada
country: Spain
facility: University of Granada
Study officials:
affiliation: Physical Therapy Deparment, Faculty of Health Sciences, University of Granada
name: Irene Cantarero-Villanueva, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Postigo-Martin P, Gil-Gutierrez R, Moreno-Gutierrez S, Lopez-Garzon M, Gonzalez-Santos A, Arroyo-Morales M, Cantarero-Villanueva I. mHealth system (ATOPE+) to support exercise prescription in breast cancer survivors: a reliability and validity, cross-sectional observational study (ATOPE study). Sci Rep. 2022 Sep 8;12(1):15217. doi: 10.1038/s41598-022-18706-7.
citation: Postigo-Martin P, Penafiel-Burkhardt R, Gallart-Aragon T, Alcaide-Lucena M, Artacho-Cordon F, Galiano-Castillo N, Fernandez-Lao C, Martin-Martin L, Lozano-Lozano M, Ruiz-Vozmediano J, Moreno-Gutierrez S, Illescas-Montes R, Arroyo-Morales M, Cantarero-Villanueva I. Attenuating Treatment-Related Cardiotoxicity in Women Recently Diagnosed With Breast Cancer via a Tailored Therapeutic Exercise Program: Protocol of the ATOPE Trial. Phys Ther. 2021 Mar 3;101(3):pzab014. doi: 10.1093/ptj/pzab014.