Preventing Chemotherapy-induced Peripheral Neuropathy Using PRESIONA Exercise Program

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determinate if therapeutic exercise with blood flow restriction (BFR) during neoadjuvant chemotherapy potentialy neurotoxic could prevent the onset of chemotherapy induced peripheral neuropathy (CIPN) comparing to usual care.

Detailed Description
-----------------
CIPN is a side effect of cancer therapies that nowadays has no solution, so our intention is to carry out a preventive therapy against the onset of CIPN. The nature of the studies that try to prevent is very diverse, but one of the wide tools is therapeutic exercise. In this case we intend to combine therapeutic exercise with BFR to obtain a pre-conditioning effect that protects intraepidermal fibers from exposure to the chemotherapy.

Official Title
-----------------
Prevention of Chemotherapy-induced Peripheral Neuropathy With Therapeutic Exercise and Blood Flow Restriction Using PRESIONA Program

Conditions
-----------------
Breast Neoplasm

Intervention / Treatment
-----------------
* Other: PRESIONA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older HER2+ breast cancer diagnosis On the waiting list to anticancer medical treatment (taxanes-based neoadjuvant chemotherapy) Exclusion Criteria: Previous diagnosis of cancer Pregnant Cardiac pathology No symptoms or pathology that could be confused with neuropathy or related to diabetes No recommendation from oncologist for therapeutic exercise practice

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRESIONA<br>An adapted therapeutic exercise program using blood flow restriction cuff perfomed during chemotherapy treatment. 24-36 sessions of 1 hour multimodal components: aerobic, strength and fascial release exercises. Frequency will be adapted to the recovery status of each patient. | Other: PRESIONA<br>* Aerobic and strength exercise combined with restricction blood flow cuffs during chemotherapy treatment<br>* Other names: Therapeutic exercise combined with blood flow restriction;|
| No Intervention: Control group<br>Patients undergoing usual medical treatment | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported CIPN symptoms | Symptoms across to sensory, motor and automic domains will be measured using the questionnarie the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN twenty-item scale. The total questionnaire has a score from 0 to 100, in which a higher score indicates increased symptom burden. | Change from Baseline to 12 weeks (after intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast cancer quality of life | assessed by European Organization for Research and Treatment of Breast Cancer-Specific Quality of Life Questionnaire. The total questionnaire has a score from 0 to 100, in which a higher score indicates increased quality of life. | Change from baseline to 12 weeks (after intervention) | 
| CIPN severity | assessed by clinical version of The Total Neuropathy Score. Each item is scored from 0 to 4, with the total score ranging from 0 to 24 points; a higher score indicates greater neuropathy severity. | Change from Baseline to 12 weeks (after intervention) | 
| Quality of sleep | assessed by Pittsburgh Sleep Quality Index that is a self-rated questionnaire which assesses sleep quality and disturbances. The global score, with a range of 0-21 points, 0 indicating no difficulty and 21 indicating severe difficulties. | Change from Baseline to 12 weeks (after intervention) | 
| Mood Assessment | assessed by Scale for Mood Assessment. The scale tries to assess four moods; anxiety, angerhostility, sadness-depression, and happiness. Itd subscale is scory from 0 to 10, a higher score in the EVEA subscales would indicate that the respondent has a higher level of sad-depressed, anxious, angryhostile, and happy mood, respectively. | Change from Baseline to 12 weeks (after intervention) | 
| Pain in hands and feet | assessed by visual analogue scale. From 0 to 10, a higher score is a worse subjective pain in hands and feet. | Change from Baseline to 12 weeks (after intervention) | 
| Touch Detection Thresholds | assessed by Semmes-Weinstein filaments (SWMs) | Change from Baseline to 12 weeks (after intervention) | 
| Handgrip strength test | assessed by TKK5101 Grp-D dynamometer (Takeya, Tokyo, Japan) | Change from Baseline to 12 weeks (after intervention) | 
| General physical functioning and mobility | assessed by the 6 minutes walking test. A greater distance (meters) covered over 6 min indicates greater mobility and general functioning. | Change from Baseline to 12 weeks (after intervention) | 
| Body composition | assesseb by bioimpedance (InBody) | Change from Baseline to 12 weeks (after intervention) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast neoplasm, Breast cancer, Therapeutic exercise, Small Fiber Neuropathy