University of Granada
Granada, 18016, Spain
NCT Number: NCT04583124
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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Notify Me18 year–70 year
Female
Interventional
Not applicable
Granada, 18016, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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.
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.
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
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.
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.
Time frame: Participants will be followed over 12 months
The Semmes-Weinstein monofilaments (SWMs) will be used to detect peripheral sensory neuropathy.
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.
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.
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).
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).
Time frame: Participants will be followed over 12 months
Flamingo test will be used to assess static body balance
Universidad de Granada
Other
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
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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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