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

Breast Neoplasm Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04583124
• Other study ID #: ATENTO19
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2021
• Est. completion date: September 30, 2025

Study information

• Verified date: May 2023
• Source: Universidad de Granada
• Contact: Irene Cantarero Villanueva, PhD
• Phone: 958248764
• Email: irenecantarero[@]ugr.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: September 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms
• Neurotoxicity Syndromes

Intervention

Other:
• ATENTO-B
Patients will perform therapeutic exercise and vagal activation techniques before medical treatment and will follow the usual care after medical treatment.
• ATENTO-T
Patients will perform therapeutic exercise and vagal activation techniques throughout medical treatment and will follow the usual care after medical treatment.

Locations

Country	Name	City	State
Spain	University of Granada	Granada

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Granada	Asociación Española contra el Cáncer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life (QLQ)	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.	Participants will be followed over 12 months
Secondary	Cognitive function: attention	The Trail Making Test will be used to assess speed for attention, sequencing, mental flexibility, visual search and motion function.	Participants will be followed over 12 months
Secondary	Cognitive function: memory and processing speed	Wechsler Adult Intelligence Scale (WAIS-IV) will be used to assess working memory and processing speed	Participants will be followed over 12 months
Secondary	Subjective cognitive function	The Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) will be used to assess the subjective cognitive functioning.	Participants will be followed over 12 months
Secondary	Intensity of symptoms	The EORTC QLQ-Chemotherapy-induced peripheral neuropathy (QLQ-CIPN20) will be used to assess neuropathic symptoms.	Participants will be followed over 12 months
Secondary	Tactile sensation	The Semmes-Weinstein monofilaments (SWMs) will be used to detect peripheral sensory neuropathy.	Participants will be followed over 12 months
Secondary	Psychological diistress	The Hospital Anxiety and Depression Scale (HADS) will be used to assess levels of anxiety and depression.	Participants will be followed over 12 months
Secondary	Presence of pain	Pressure pain thresholds (PPT) will be used to explore bilaterally the quadriceps, deltoid, trapezius and cervical muscles using an algometer.	Participants will be followed over 12 months.
Secondary	Sleep disturbance	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).	Participants will be followed over 12 months
Secondary	Cardiorespiratory fitness	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).	Participants will be followed over 12 months
Secondary	Static body balance	Flamingo test will be used to assess static body balance	Participants will be followed over 12 months