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

University of Granada (UGR)

Status: Completed

Conditions: Breast Neoplasm

Treatments: Other: ATENTO-T; Other: ATENTO-B

Study type: Interventional

Funder types: Other

Identifiers

NCT04583124

ATENTO19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups

ATENTO-B

Experimental group

Description:

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.

Treatment:

Other: ATENTO-B

ATENTO-T

Active Comparator group

Description:

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.

Treatment:

Other: ATENTO-T