NCT04583124

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 12, 2020

Completed
12 months until next milestone

Study Start

First participant enrolled

September 30, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2025

Completed
Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

3.3 years

First QC Date

October 5, 2020

Last Update Submit

November 15, 2025

Conditions

Breast Neoplasm

Keywords

Breast neoplasmBreast cancerTherapeutic ExerciseNeurotoxicityVagal activation techniques

Outcome Measures

Primary Outcomes (1)

  • 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.

    Participants will be followed over 12 months

Secondary Outcomes (10)

  • Cognitive function: attention

    Participants will be followed over 12 months

  • Cognitive function: memory and processing speed

    Participants will be followed over 12 months

  • Subjective cognitive function

    Participants will be followed over 12 months

  • Intensity of symptoms

    Participants will be followed over 12 months

  • Tactile sensation

    Participants will be followed over 12 months

  • +5 more secondary outcomes

Study Arms (2)

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.

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.

Other: ATENTO-T

Interventions

ATENTO-BOTHER

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

Also known as: Multimodal program (therapeutic exercise and vagal activation techniques) before medical treatment
ATENTO-B
ATENTO-TOTHER

Patients will perform therapeutic exercise and vagal activation techniques throughout medical treatment and will follow the usual care after medical treatment.

Also known as: Multimodal program (therapeutic exercise and vagal activation techniques) throughout medical treatment
ATENTO-T

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Granada

Granada, 18016, Spain

Location

MeSH Terms

Conditions

Breast NeoplasmsNeurotoxicity Syndromes

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNervous System DiseasesPoisoningChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Irene Cantarero Villanueva

Study Record Dates

First Submitted

October 5, 2020

First Posted

October 12, 2020

Study Start

September 30, 2021

Primary Completion

December 31, 2024

Study Completion

November 14, 2025

Last Updated

November 18, 2025

Record last verified: 2025-11

Locations

ES(1)