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

Phase

N/A

Condition

Breast Cancer

Treatment

ATENTO-B

ATENTO-T

Clinical Study ID

NCT04583124

ATENTO19

Ages 18-70
Female

Study 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.

Eligibility Criteria

Inclusion

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/orperipheral neurotoxicity.
To have signed the informed consent.
To have medical clearance for participation.

Exclusion

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 nervoussystem and could influence the results.

Study Design

ATENTO-B

September 30, 2021

September 30, 2025

Study 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.

Connect with a study center

University of Granada
Granada, 18016
Spain
Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.