Breast Neoplasm
Conditions
Keywords
Breast neoplasm, Breast cancer, Therapeutic Exercise, Neurotoxicity, Vagal activation techniques
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.
Interventions
OTHERATENTO-B
Patients will perform therapeutic exercise and vagal activation techniques before medical treatment and will follow the usual care after medical treatment.
OTHERATENTO-T
Patients will perform therapeutic exercise and vagal activation techniques throughout medical treatment and will follow the usual care after medical treatment.
Sponsors
Asociación Española contra el Cáncer
Universidad de Granada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life (QLQ) | 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
| Measure | Time frame | Description |
|---|---|---|
| Cognitive function: memory and processing speed | Participants will be followed over 12 months | Wechsler Adult Intelligence Scale (WAIS-IV) will be used to assess working memory and processing speed |
| Subjective cognitive function | 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. |
| Intensity of symptoms | Participants will be followed over 12 months | The EORTC QLQ-Chemotherapy-induced peripheral neuropathy (QLQ-CIPN20) will be used to assess neuropathic symptoms. |
| Tactile sensation | Participants will be followed over 12 months | The Semmes-Weinstein monofilaments (SWMs) will be used to detect peripheral sensory neuropathy. |
| Cognitive function: attention | 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. |
| Presence of pain | 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. |
| Sleep disturbance | 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). |
| Cardiorespiratory fitness | 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). |
| Static body balance | Participants will be followed over 12 months | Flamingo test will be used to assess static body balance |
| Psychological diistress | Participants will be followed over 12 months | The Hospital Anxiety and Depression Scale (HADS) will be used to assess levels of anxiety and depression. |
Countries
Spain
Outcome results
None listed