Preventing Chemotherapy-induced Peripheral Neuropathy Using PRESIONA Exercise Program (PRESIONA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Neoplasm
• Intervention / Treatment: Other: PRESIONA

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.

• Study Type: Interventional
• Enrollment (Estimated): 25
• 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
    • Sub-Investigator: Noelia Galiano-Castillo, Phd
    • Principal Investigator: Irene Cantarero-Villanueva, Phd
    • Sub-Investigator: Maria de la Cabeza Lopez-Garzon, MsC

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRESIONA; 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; Aerobic and strength exercise combined with restricction blood flow cuffs during chemotherapy treatment; Other Names: Experimental group; Therapeutic exercise combined with blood flow restriction
No Intervention: Control group; 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)

Collaborators and Investigators

• Sponsor: Universidad de Granada
• Investigators: Principal Investigator: Irene Cantarero-Villanueva, PhD, Physical Therapy Deparment, Faculty of Health Sciences, University of Granada

Publications and helpful links

General Publications

• Lopez-Garzon M, Cantarero-Villanueva I, Legeren-Alvarez M, Gallart-Aragon T, Postigo-Martin P, Gonzalez-Santos A, Lozano-Lozano M, Martin-Martin L, Ortiz-Comino L, Castro-Martin E, Ariza-Garcia A, Fernandez-Lao C, Arroyo-Morales M, Galiano-Castillo N. Prevention of Chemotherapy-Induced Peripheral Neuropathy With PRESIONA, a Therapeutic Exercise and Blood Flow Restriction Program: A Randomized Controlled Study Protocol. Phys Ther. 2022 Mar 1;102(3):pzab282. doi: 10.1093/ptj/pzab282.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): January 1, 2025
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: October 20, 2020
• First Submitted That Met QC Criteria: December 1, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Estimated): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 15, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Breast cancer; Therapeutic exercise; Breast neoplasm; Small Fiber Neuropathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Site; Neoplasms; Neuromuscular Diseases; Peripheral Nervous System Diseases; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Small Fiber Neuropathy; Breast Neoplasms
• Other Study ID Numbers: PRESIONA20

Drug and device information, study documents

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