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Breast NeoplasmsATOPENCT03787966

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

A study testing ATOPE-B and ATOPE-I in people with Breast Neoplasms, run by Universidad de Granada at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Neoplasms
What is being tested?
ATOPE-B and ATOPE-I
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteSpain
Study dates
1 Sep 2019to 14 Nov 2025
Phase
Interventional
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 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.).

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • University of Granada

    Granada, 18016

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
ATOPE-B, ATOPE-I
Keywords
Breast neoplasm, Breast cancer, therapeutic exercise, cardiotoxicity, muscle toxicity
Medical subject headings
Breast Neoplasms, Cardiotoxicity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ATOPE-BOther

    Also called Therapeutic exercise before medical treatment

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

  • ATOPE-IOther

    Also called Therapeutic exercise during medical treatment

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

Study groups in NCT03787966
Study groupRoleWhat they receive
ATOPE-BExperimentalAn 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).
Receives: Other: ATOPE-B
ATOPE-IActive comparatorAn 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).
Receives: Other: ATOPE-I

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Left ventricular ejection fraction

    To assess cardiac toxicity by echocardiography

    Measured: Participants will be followed over 12 months

Secondary outcomes (29)

  1. Cardiovascular events

    Number of cardiovascular events registered in a diary

    Measured: Participants will be followed over 12 months

  2. Resting heart rate

    To assess cardiac function by a Holter

    Measured: Participants will be followed over 12 months

  3. Heart Rate variability

    To assess cardiac autonomic system balance by a Holter

    Measured: Participants will be followed over 12 months

  4. Muscle loss

    To assess muscle mass loss by Inbody

    Measured: Participants will be followed over 12 months

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

    With the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0. It is used to asses quality of life. It contains 30 items with both multi-item scales and single-item measures. Values are assigned between 1 and 4 (1: not at all, 2: a little, 3: enough, 4: a lot) according to the patient's responses to the item, only in items 29 and 30 evaluate with a score of 1 to 7 (1: lousy, 7: excellent). The scores obtained are standardized and a score between 0 and 100 is obtained, which determines the level of cancer impact on the patient of each of the scales. The high values in the scales of global health and function state indicate a better CV, while in the scale of symptoms it would indicate a decrease in CV since it indicates the presence of symptoms associated with cancer.

    Measured: Participants will be followed over 12 months

  6. Quality of life with the Quality of life Questionnaire (QLQ- BR23) a specific module.

    European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23). It is a breast cancer module of EORTC QLQ-C30. This module contains 23 items assessing symptoms and side effects related to different treatment modalities, body image, sexuality, and future perspective. After the scoring procedures for the QLQ-C30, all scale and single-item scores are linearly transformed to a 0 to 100 scale. For the functional scales and single items (ie, body image, sexuality, and future perspective), higher scores represent a better level of functioning. For the symptom scales and single item, a higher score represents a higher level of symptoms.

    Measured: Participants will be followed over 12 months but will not be assessed in baseline

  7. Chemotherapy regimen

    type of chemotherapy agent used and number of sessions.

    Measured: Participants will be followed over 12 months

  8. Chemotherapy doses modifications

    delay of doses or reduction, total doses received from the total expected.

    Measured: Participants will be followed over 12 months

  9. Early session termination.

    Patient stopped receiving chemotherapy before last >=1 sessions.

    Measured: Participants will be followed over 12 months

  10. Missing bouts due to adverse effects of chemotherapy

    Adverse effects of chemotherapy treatment and if it was interrupted (>=3 missing consecutive bouts of exercise)

    Measured: Participants will be followed over 12 months

  11. Number of hospitalizations.

    Measured: Participants will be followed over 12 months

  12. Therapeutic exercise bout modification

    >=1 bout that required a dose modification during the program and number of bouts modified in total.

    Measured: Participants will be followed over 12 months

  13. Time to treatment failure

    days from the start to the end of chemotherapy, if it was terminated for toxicity and/or tumor progression.

    Measured: Participants will be followed over 12 months

  14. Program adverse effects reported by the participants.

    Frequency of serious and non-serious events occurring during program.

    Measured: Participants will be followed over 12 months

  15. Functional capacity

    assessed by the 6-Minute Walking Test

    Measured: Participants will be followed over 12 months

  16. Handgrip strength

    assessed by a digital dynamometer: TKK 5101 Grip-D; Takey, Tokyo, Japan

    Measured: Participants will be followed over 12 months

  17. Shoulder strength

    assessed by an isokinetic test with an isokinetic dynamometer (HUMAC NORM)

    Measured: Participants will be followed over 12 months

  18. Lower limb strength

    assessed by an isokinetic test with an isokinetic dynamometer (HUMAC NORM)

    Measured: Participants will be followed over 12 months

  19. Abdominal strength

    assessed by an isokinetic test with an isokinetic dynamometer (HUMAC NORM)

    Measured: Participants will be followed over 12 months

  20. Flexibility

    assessed by the Modified sit-and-reach test

    Measured: Participants will be followed over 12 months

  21. Waist and hip circumferences

    assessed by an inelastic tape

    Measured: Participants will be followed over 12 months

  22. Body composition

    assessed by the InBody

    Measured: Participants will be followed over 12 months

  23. Oxidative stress

    Thiobarbituric acid reactive substances (TBARS)

    Measured: Participants will be followed over 12 months

  24. Oxidative stress

    carbonyls and 8-hydroxy-2' -deoxyguanosine (8-OHdG)

    Measured: Participants will be followed over 12 months

  25. Inmune function

    Number of lymphocytes: (cluster of differentiation (CD) 8 and 4 and regulatory T lymphocytes)

    Measured: Participants will be followed over 12 months

  26. inflammation

    C-reactive protein (CRP)

    Measured: Participants will be followed over 12 months

  27. inflammation

    interleukin (IL) 6 and 10

    Measured: Participants will be followed over 12 months

  28. inflammation

    tumor necrosis factor (TNF) alpha

    Measured: Participants will be followed over 12 months

  29. inflammation

    insulin-like growth factor 1 (IGF-1)

    Measured: Participants will be followed over 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2018
  2. Study start1 Sep 2019
  3. Primary completion15 Jun 2025
  4. Study completion14 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03787966
Sponsor's protocol ID
ATOPE18
Acronym
ATOPE
Status last verified
Nov 2025
First submitted
14 Dec 2018
Last updated
19 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 36076044

  • 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.

    PubMed 33528004

Questions about this trial

What is this clinical trial studying?

A study testing ATOPE-B and ATOPE-I in people with Breast Neoplasms, run by Universidad de Granada 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 6 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 19 Nov 2025. 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?

Left ventricular ejection fraction (time frame: Participants will be followed over 12 months). 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 NCT03787966, which also lists 2 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 19 Nov 2025.

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