Adjusting the Dose of Therapeutic Exercise to Prevent Neurotoxicity Due to Anticancer Treatment (ATENTO)

NCT ID: NCT04583124

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2025-11-14

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.

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

Study Design

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

Study Groups

ATENTO-B

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.

Group Type: EXPERIMENTAL

ATENTO-B

Intervention Type: OTHER

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

ATENTO-T

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.

Group Type: ACTIVE_COMPARATOR

ATENTO-T

Intervention Type: OTHER

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

Interventions

ATENTO-B

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

Intervention Type: OTHER

ATENTO-T

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

Intervention Type: OTHER

Other Intervention Names

Multimodal program (therapeutic exercise and vagal activation techniques) before medical treatment; Multimodal program (therapeutic exercise and vagal activation techniques) throughout medical treatment

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

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

Sponsors

Asociación Española contra el Cáncer

OTHER

Sponsor Role: collaborator

Universidad de Granada

OTHER

Sponsor Role: lead

Responsible Party

Irene Cantarero Villanueva

Irene Cantarero Villanueva

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Granada

Granada, , Spain

Countries

Spain

Other Identifiers

ATENTO19

Identifier Type: -

Identifier Source: org_study_id