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NCT Number: NCT04652609

Preventing Chemotherapy-induced Peripheral Neuropathy Using PRESIONA Exercise 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.

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Key information

Conditions

Breast Neoplasm Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Skin Diseases Skin and Connective Tissue Diseases Small Fiber Neuropathy

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Granada

Granada, 18016, Spain

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRESIONA

Other

Aerobic and strength exercise combined with restricction blood flow cuffs during chemotherapy treatment

Other names: Experimental group, Therapeutic exercise combined with blood flow restriction

Primary outcomes

  1. Patient-reported CIPN symptoms

    Time frame: Change from Baseline to 12 weeks (after intervention)

    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.

Secondary outcomes

  1. Breast cancer quality of life

    Time frame: Change from baseline to 12 weeks (after intervention)

    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.

  2. CIPN severity

    Time frame: Change from Baseline to 12 weeks (after intervention)

    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.

  3. Quality of sleep

    Time frame: Change from Baseline to 12 weeks (after intervention)

    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.

  4. Mood Assessment

    Time frame: Change from Baseline to 12 weeks (after intervention)

    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.

  5. Pain in hands and feet

    Time frame: Change from Baseline to 12 weeks (after intervention)

    assessed by visual analogue scale. From 0 to 10, a higher score is a worse subjective pain in hands and feet.

  6. Touch Detection Thresholds

    Time frame: Change from Baseline to 12 weeks (after intervention)

    assessed by Semmes-Weinstein filaments (SWMs)

  7. Handgrip strength test

    Time frame: Change from Baseline to 12 weeks (after intervention)

    assessed by TKK5101 Grp-D dynamometer (Takeya, Tokyo, Japan)

  8. General physical functioning and mobility

    Time frame: Change from Baseline to 12 weeks (after intervention)

    assessed by the 6 minutes walking test. A greater distance (meters) covered over 6 min indicates greater mobility and general functioning.

  9. Body composition

    Time frame: Change from Baseline to 12 weeks (after intervention)

    assesseb by bioimpedance (InBody)

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study title

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

Acronym: PRESIONA

Important dates

Study start
2021
Primary completion
2025
Study completion
2027
First posted
Dec 3, 2020
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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