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Completed

NCT Number: NCT04583124

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Granada

Granada, 18016, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ATENTO-B

Other

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

Other names: Multimodal program (therapeutic exercise and vagal activation techniques) before medical treatment

ATENTO-T

Other

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

Other names: Multimodal program (therapeutic exercise and vagal activation techniques) throughout medical treatment

Primary outcomes

  1. Quality of life (QLQ)

    Time frame: Participants will be followed over 12 months

    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.

Secondary outcomes

  1. Cognitive function: attention

    Time frame: Participants will be followed over 12 months

    The Trail Making Test will be used to assess speed for attention, sequencing, mental flexibility, visual search and motion function.

  2. Cognitive function: memory and processing speed

    Time frame: Participants will be followed over 12 months

    Wechsler Adult Intelligence Scale (WAIS-IV) will be used to assess working memory and processing speed

  3. Subjective cognitive function

    Time frame: Participants will be followed over 12 months

    The Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) will be used to assess the subjective cognitive functioning.

  4. Intensity of symptoms

    Time frame: Participants will be followed over 12 months

    The EORTC QLQ-Chemotherapy-induced peripheral neuropathy (QLQ-CIPN20) will be used to assess neuropathic symptoms.

  5. Tactile sensation

    Time frame: Participants will be followed over 12 months

    The Semmes-Weinstein monofilaments (SWMs) will be used to detect peripheral sensory neuropathy.

  6. Psychological diistress

    Time frame: Participants will be followed over 12 months

    The Hospital Anxiety and Depression Scale (HADS) will be used to assess levels of anxiety and depression.

  7. Presence of pain

    Time frame: Participants will be followed over 12 months.

    Pressure pain thresholds (PPT) will be used to explore bilaterally the quadriceps, deltoid, trapezius and cervical muscles using an algometer.

  8. Sleep disturbance

    Time frame: Participants will be followed over 12 months

    The Pittsburgh Sleep Quality Index (PSQI) will evaluate the quality of sleep through seven dimensions (quality, latency, duration, efficiency, alterations, use of medication and daily dysfunction).

  9. Cardiorespiratory fitness

    Time frame: Participants will be followed over 12 months

    Cardiopulmonary exercise test will be performed with a Medisoft, 870 A treadmill and Jaeger MasterScreen® CPX gas analyser to assess VO2 peak following the University of Northern Colorado Cancer Rehabilitation Institute (UNCCRI).

  10. Static body balance

    Time frame: Participants will be followed over 12 months

    Flamingo test will be used to assess static body balance

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Collaborators

  • Asociación Española contra el Cáncer

Registry information

Official study 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.

Acronym: ATENTO

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Oct 12, 2020
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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