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

NCT03787966 | Completed

• 1 other identifier: ATOPE18
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Keywords

Breast neoplasm; Breast cancer; therapeutic exercise; cardiotoxicity; muscle toxicity

Outcome Measures

Primary Outcomes (1)

• Left ventricular ejection fraction

  To assess cardiac toxicity by echocardiography

  Participants will be followed over 12 months

Secondary Outcomes (29)

• Cardiovascular events

  Participants will be followed over 12 months

• Resting heart rate

  Participants will be followed over 12 months

• Heart Rate variability

  Participants will be followed over 12 months

• Muscle loss

  Participants will be followed over 12 months

• Quality of life with the Quality of Life Questionnaire (QLQ)-C30

  Participants will be followed over 12 months

Study Arms (2)

ATOPE-B

EXPERIMENTAL

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).

Other: ATOPE-B

ATOPE-I

ACTIVE COMPARATOR

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).

Other: ATOPE-I

Interventions

ATOPE-B OTHER

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

Also known as: Therapeutic exercise before medical treatment

ATOPE-B

ATOPE-I OTHER

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

Also known as: Therapeutic exercise during medical treatment

ATOPE-I

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

University of Granada

Granada, 18016, Spain

Location

Related Publications (2)

• 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.

  PMID: 36076044 DERIVED

• 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.

  PMID: 33528004 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Cardiotoxicity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Officials

• Irene Cantarero-Villanueva, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: December 27, 2018
• Study Start: September 1, 2019
• Primary Completion: June 15, 2025
• Study Completion: November 14, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

ES (1)