Attenuating Cancer Treatment-related Toxicity in Oncology Patients With a Tailored Physical Exercise Program

NCT ID: NCT03787966

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2025-11-14

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.

Conditions

Breast Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ATOPE-B

An adapted therapeutic exercise program performed before medical treatment. 18 bouts of 1'5 hours multimodal components: aerobic, strength and fascial release exercises. Bout frequency will be adapted to the recovery status of each patient (heart rate variability training parameters and patient perception).

Group Type: EXPERIMENTAL

ATOPE-B

Intervention Type: OTHER

Patients will perform therapeutic exercise before medical treatment and will follow the usual care after medical treatment.

ATOPE-I

An adapted therapeutic exercise program performed during medical treatment. 18 bouts of 1'5 hours multimodal components: aerobic, strength and fascial release exercises. Bout frequency will be adapted to the recovery status of each patient (heart rate variability training parameters and patient perception).

Group Type: ACTIVE_COMPARATOR

ATOPE-I

Intervention Type: OTHER

Patients will follow usual care before medical treatment and will perform therapeutic exercise after medical treatment.

Interventions

ATOPE-B

Patients will perform therapeutic exercise before medical treatment and will follow the usual care after medical treatment.

Intervention Type: OTHER

ATOPE-I

Patients will follow usual care before medical treatment and will perform therapeutic exercise after medical treatment.

Intervention Type: OTHER

Other Intervention Names

Therapeutic exercise before medical treatment; Therapeutic exercise during medical treatment

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.).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Granada

OTHER

Sponsor Role: lead

Responsible Party

Irene Cantarero Villanueva

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Irene Cantarero-Villanueva, PhD

Role: PRINCIPAL_INVESTIGATOR

Physical Therapy Deparment, Faculty of Health Sciences, University of Granada

Locations

University of Granada

Granada, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 36076044 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33528004 (View on PubMed)

Other Identifiers

ATOPE18

Identifier Type: -

Identifier Source: org_study_id