Breast NeoplasmATENTONCT04583124
Adjusting the Dose of Therapeutic Exercise to Prevent Neurotoxicity Due to Anticancer Treatment (ATENTO)
A study testing ATENTO-B and ATENTO-T in people with Breast Neoplasm, run by Universidad de Granada at 1 site in Spain.
Trial summary
The purpose of this study is to determine whether a multimodal program based on therapeutic exercise and vagal activation techniques for newly diagnosed breast cancer women has better results in terms of neurotoxicity prevenion before or during medical treatments. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- ATENTO-B and ATENTO-T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- 30 Sep 2021to 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
- To have 18 years or older
- To have a breast cancer diagnosis (Stage I-III)
- To be on waiting list for medical adjuvant treatment with risk of central and/or peripheral neurotoxicity.
- To have signed the informed consent.
- To have medical clearance for participation.
Who cannot join
- To have a previous history of cancer or any cancer treatment.
- Pregnant patients.
- To participate in another intervention that could influence on the outcomes.
- To have a neurodegenerative disease that affects central or peripheral nervous system and could influence the results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neurotoxicity Prevention With a Multimodal Program (ATENTO) Prior to Cancer Treatment Versus Throughout Cancer Treatment in Women Newly Diagnosed for Breast Cancer: a Randomized Clinical Trial.
The purpose of this study is to determine whether a multimodal program based on therapeutic exercise and vagal activation techniques for newly diagnosed breast cancer women has better results in terms of neurotoxicity prevenion before or during medical treatments.
Read the detailed description
One of the most common side effects of breast cancer and its treatments is neurotoxicity of central and peripheral nervous system. Neurotoxicity is present in up to 75% of this population, which implies a large impact in quality of life. There is a special interest in the preventive possibilities of therapeutic exercise relating to these neurological sequelae, whose benefits could improve thanks to the combination with vagal activation techniques.
This superiority randomized controlled trial will be aimed to check the effects of a multimodal intervention (ATENTO) based on moderate-high intensity and individualized therapeutic exercise (aerobic and strength exercises) and vagal activation techniques (myofascial stretching and breathing exercises), on neurotoxicity prevention in women with breast cancer before starting potentially neurotoxic treatments (ATENTO-B) versus throughout them (ATENTO-T). A sample of 56 women newly diagnosed with breast cancer calculated with a power of 85% will be allocated into two groups.
This study could provide an impetus for the introduction of early multimodal intervention methods of preventing neurotoxicity and consequently avoid the current QoL deterioration that breast cancer patients suffer throughout their treatments.
- Conditions
- Breast Neoplasm
- Being tested
- ATENTO-B, ATENTO-T
- Keywords
- Breast neoplasm, Breast cancer, Therapeutic Exercise, Neurotoxicity, Vagal activation techniques
- Medical subject headings
- Breast Neoplasms, Neurotoxicity Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATENTO-BOther
Also called Multimodal program (therapeutic exercise and vagal activation techniques) before medical treatment
Patients will perform therapeutic exercise and vagal activation techniques before medical treatment and will follow the usual care after medical treatment.
ATENTO-TOther
Also called Multimodal program (therapeutic exercise and vagal activation techniques) throughout medical treatment
Patients will perform therapeutic exercise and vagal activation techniques throughout medical treatment and will follow the usual care after medical treatment.
| Study group | Role | What they receive |
|---|---|---|
| ATENTO-B | Experimental | A multimodal program based on adapted therapeutic exercise and vagal activation techniques performed before the begining of medical treatment for breast cancer. It consits of 18 sessions to perform aerobic and strength exercises (90' approximately plus myofascial stretching and breathing exercises (20'). Frequency of sessions will be adapted to the recovery of each patients (by heart rate variability parameters and patient perception).
ATENTO is divided in two parts: a) general phase: aimed to improve the overall physical health condition and to correctly learn the execution of each exercise (2 weeks); and b) specific phase: aimed to neurotoxicity prevention. Receives: Other: ATENTO-B |
| ATENTO-T | Active comparator | A multimodal program based on adapted therapeutic exercise and vagal activation techniques performed throughout medical treatment for breast cancer. It consits of 18 sessions to perform aerobic and strength exercises (90' approximately plus myofascial stretching and breathing exercises (20'). Frequency of sessions will be adapted to the recovery of each patients (by heart rate variability parameters and patient perception).
ATENTO is divided in two parts: a) general phase: aimed to improve the overall physical health condition and to correctly learn the execution of each exercise (2 weeks); and b) specific phase: aimed to neurotoxicity prevention. Receives: Other: ATENTO-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (QLQ)
The primary outcome will be assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0, that is one of the most widely used instruments to measure quality of life in cancer patients.
Measured: Participants will be followed over 12 months
Secondary outcomes (10)
Cognitive function: attention
The Trail Making Test will be used to assess speed for attention, sequencing, mental flexibility, visual search and motion function.
Measured: Participants will be followed over 12 months
Cognitive function: memory and processing speed
Wechsler Adult Intelligence Scale (WAIS-IV) will be used to assess working memory and processing speed
Measured: Participants will be followed over 12 months
Subjective cognitive function
The Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) will be used to assess the subjective cognitive functioning.
Measured: Participants will be followed over 12 months
Intensity of symptoms
The EORTC QLQ-Chemotherapy-induced peripheral neuropathy (QLQ-CIPN20) will be used to assess neuropathic symptoms.
Measured: Participants will be followed over 12 months
Tactile sensation
The Semmes-Weinstein monofilaments (SWMs) will be used to detect peripheral sensory neuropathy.
Measured: Participants will be followed over 12 months
Psychological diistress
The Hospital Anxiety and Depression Scale (HADS) will be used to assess levels of anxiety and depression.
Measured: Participants will be followed over 12 months
Presence of pain
Pressure pain thresholds (PPT) will be used to explore bilaterally the quadriceps, deltoid, trapezius and cervical muscles using an algometer.
Measured: Participants will be followed over 12 months.
Sleep disturbance
The Pittsburgh Sleep Quality Index (PSQI) will evaluate the quality of sleep through seven dimensions (quality, latency, duration, efficiency, alterations, use of medication and daily dysfunction).
Measured: Participants will be followed over 12 months
Cardiorespiratory fitness
Cardiopulmonary exercise test will be performed with a Medisoft, 870 A treadmill and Jaeger MasterScreen® CPX gas analyser to assess VO2 peak following the University of Northern Colorado Cancer Rehabilitation Institute (UNCCRI).
Measured: Participants will be followed over 12 months
Static body balance
Flamingo test will be used to assess static body balance
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.
- First posted12 Oct 2020
- Study start30 Sep 2021
- Primary completion31 Dec 2024
- Study completion14 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- Asociación Española contra el Cáncer
- Responsible party
- Principal investigator, Irene Cantarero Villanueva, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583124
- Sponsor's protocol ID
- ATENTO19
- Acronym
- ATENTO
- Status last verified
- Nov 2025
- First submitted
- 5 Oct 2020
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurotoxicity Prevention With a Multimodal Program (ATENTO) Prior to Cancer Treatment Versus Throughout Cancer Treatment in Women Newly Diagnosed for Breast Cancer: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04583124
- Acronym / sponsor ID
- ATENTO / ATENTO19
- Conditions
- Breast Neoplasm
- Keywords
- Breast neoplasm, Breast cancer, Therapeutic Exercise, Neurotoxicity, Vagal activation techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- Asociación Española contra el Cáncer
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 14 Nov 2025 (actual)
- First posted
- 12 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a multimodal program based on therapeutic exercise and vagal activation techniques for newly diagnosed breast cancer women has better results in terms of neurotoxicity prevenion before or during medical treatments.
Detailed description
One of the most common side effects of breast cancer and its treatments is neurotoxicity of central and peripheral nervous system. Neurotoxicity is present in up to 75% of this population, which implies a large impact in quality of life. There is a special interest in the preventive possibilities of therapeutic exercise relating to these neurological sequelae, whose benefits could improve thanks to the combination with vagal activation techniques.
This superiority randomized controlled trial will be aimed to check the effects of a multimodal intervention (ATENTO) based on moderate-high intensity and individualized therapeutic exercise (aerobic and strength exercises) and vagal activation techniques (myofascial stretching and breathing exercises), on neurotoxicity prevention in women with breast cancer before starting potentially neurotoxic treatments (ATENTO-B) versus throughout them (ATENTO-T). A sample of 56 women newly diagnosed with breast cancer calculated with a power of 85% will be allocated into two groups.
This study could provide an impetus for the introduction of early multimodal intervention methods of preventing neurotoxicity and consequently avoid the current QoL deterioration that breast cancer patients suffer throughout their treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATENTO-B | Experimental | Other: ATENTO-BA multimodal program based on adapted therapeutic exercise and vagal activation techniques performed before the begining of medical treatment for breast cancer. It consits of 18 sessions to perform aerobic and strength exercises (90' approximately plus myofascial stretching and breathing exercises (20'). Frequency of sessions will be adapted to the recovery of each patients (by heart rate variability parameters and patient perception). ATENTO is divided in two parts: a) general phase: aimed to improve the overall physical health condition and to correctly learn the execution of each exercise (2 weeks); and b) specific phase: aimed to neurotoxicity prevention. |
| ATENTO-T | Active comparator | Other: ATENTO-TA multimodal program based on adapted therapeutic exercise and vagal activation techniques performed throughout medical treatment for breast cancer. It consits of 18 sessions to perform aerobic and strength exercises (90' approximately plus myofascial stretching and breathing exercises (20'). Frequency of sessions will be adapted to the recovery of each patients (by heart rate variability parameters and patient perception). ATENTO is divided in two parts: a) general phase: aimed to improve the overall physical health condition and to correctly learn the execution of each exercise (2 weeks); and b) specific phase: aimed to neurotoxicity prevention. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- To have 18 years or older
- To have a breast cancer diagnosis (Stage I-III)
- To be on waiting list for medical adjuvant treatment with risk of central and/or peripheral neurotoxicity.
- To have signed the informed consent.
- To have medical clearance for participation.
Key exclusion criteria (4 listed)
- To have a previous history of cancer or any cancer treatment.
- Pregnant patients.
- To participate in another intervention that could influence on the outcomes.
- To have a neurodegenerative disease that affects central or peripheral nervous system and could influence the results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATENTO-BAlso: Multimodal program (therapeutic exercise and vagal activation techniques) before medical treatmentPatients will perform therapeutic exercise and vagal activation techniques before medical treatment and will follow the usual care after medical treatment. | Other | ATENTO-B |
| ATENTO-TAlso: Multimodal program (therapeutic exercise and vagal activation techniques) throughout medical treatmentPatients will perform therapeutic exercise and vagal activation techniques throughout medical treatment and will follow the usual care after medical treatment. | Other | ATENTO-T |
Primary outcome
Quality of life (QLQ)
Time frame: Participants will be followed over 12 months
The primary outcome will be assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0, that is one of the most widely used instruments to measure quality of life in cancer patients.
10 secondary outcomes
Cognitive function: attention
Time frame: Participants will be followed over 12 months
Cognitive function: memory and processing speed
Time frame: Participants will be followed over 12 months
Subjective cognitive function
Time frame: Participants will be followed over 12 months
Intensity of symptoms
Time frame: Participants will be followed over 12 months
Tactile sensation
Time frame: Participants will be followed over 12 months
Psychological diistress
Time frame: Participants will be followed over 12 months
Presence of pain
Time frame: Participants will be followed over 12 months.
Sleep disturbance
Time frame: Participants will be followed over 12 months
Cardiorespiratory fitness
Time frame: Participants will be followed over 12 months
Static body balance
Time frame: Participants will be followed over 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATENTO-B and ATENTO-T in people with Breast Neoplasm, 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 5 inclusion and 4 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 18 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?
Quality of life (QLQ) (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?
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 18 Nov 2025.