Clinical trial NCT04583124: Adjusting the Dose of Therapeutic Exercise to Prevent Neurotoxicity Due to Anticancer Treatment (ATENTO)
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Neoplasm
Keywords: Breast neoplasm
Breast cancer
Therapeutic Exercise
Neurotoxicity
Vagal activation techniques
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: Asociación Española contra el Cáncer
First posted: 2020-10-12
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Quality of life (QLQ)
timeFrame: Participants will be followed over 12 months
Secondary outcomes:
measure: Cognitive function: attention
timeFrame: Participants will be followed over 12 months
measure: Cognitive function: memory and processing speed
timeFrame: Participants will be followed over 12 months
measure: Subjective cognitive function
timeFrame: Participants will be followed over 12 months
measure: Intensity of symptoms
timeFrame: Participants will be followed over 12 months
measure: Tactile sensation
timeFrame: Participants will be followed over 12 months
measure: Psychological diistress
timeFrame: Participants will be followed over 12 months
measure: Presence of pain
timeFrame: Participants will be followed over 12 months.
measure: Sleep disturbance
timeFrame: Participants will be followed over 12 months
measure: Cardiorespiratory fitness
timeFrame: Participants will be followed over 12 months
measure: Static body balance
timeFrame: Participants will be followed over 12 months
Other outcomes:
Locations:
city: Granada
country: Spain
facility: University of Granada
Study officials:
References: