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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Neoplasm
• Intervention / Treatment: Other: ATENTO-B; Other: ATENTO-T

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.

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Irene Cantarero Villanueva, PhD; Phone Number: 958248764; Email: irenecantarero@ugr.es

Study Locations

• Spain
  • Granada, Spain, 18016
    • Recruiting
    • University of Granada
    • Contact: Irene Cantarero-Villanueva, PhD; Phone Number: 958248764; Email: irenecantarero@ugr.es
    • Principal Investigator: Irene Cantarero-Villanueva, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ATENTO-B; A multimodal program based on adapted therapeutic exercise and vagal activation techniques performed before the begining of medical treatment for breast cancer. It consits of 18 sessions to perform aerobic and strength exercises (90' approximately plus myofascial stretching and breathing exercises (20'). Frequency of sessions will be adapted to the recovery of each patients (by heart rate variability parameters and patient perception). ATENTO is divided in two parts: a) general phase: aimed to improve the overall physical health condition and to correctly learn the execution of each exercise (2 weeks); and b) specific phase: aimed to neurotoxicity prevention.	Other: ATENTO-B; 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
Active Comparator: ATENTO-T; A multimodal program based on adapted therapeutic exercise and vagal activation techniques performed throughout medical treatment for breast cancer. It consits of 18 sessions to perform aerobic and strength exercises (90' approximately plus myofascial stretching and breathing exercises (20'). Frequency of sessions will be adapted to the recovery of each patients (by heart rate variability parameters and patient perception). ATENTO is divided in two parts: a) general phase: aimed to improve the overall physical health condition and to correctly learn the execution of each exercise (2 weeks); and b) specific phase: aimed to neurotoxicity prevention.	Other: ATENTO-T; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Tactile sensation	The Semmes-Weinstein monofilaments (SWMs) will be used to detect peripheral sensory neuropathy.	Participants will be followed over 12 months
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
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.
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
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
Static body balance	Flamingo test will be used to assess static body balance	Participants will be followed over 12 months

Collaborators and Investigators

• Sponsor: Universidad de Granada
• Collaborators: Asociación Española contra el Cáncer

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: October 5, 2020
• First Posted (Actual): October 12, 2020

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Breast cancer; Breast neoplasm; Therapeutic Exercise; Neurotoxicity; Vagal activation techniques
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Nervous System Diseases; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Poisoning; Breast Neoplasms; Neurotoxicity Syndromes
• Other Study ID Numbers: ATENTO19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No