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Recruiting NCT04652609

Preventing Chemotherapy-induced Peripheral Neuropathy Using PRESIONA Exercise Program

No phase Interventional Breast Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PRESIONA.
Who it may be relevant to
Registry conditions: Breast Neoplasm. Basic parameters: 18 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Patient-reported CIPN symptoms [Time frame: Change from Baseline to 12 weeks (after intervention)]
Secondary outcome measures (9)
  • Breast cancer quality of life [Time frame: Change from baseline to 12 weeks (after intervention)]
  • CIPN severity [Time frame: Change from Baseline to 12 weeks (after intervention)]
  • Quality of sleep [Time frame: Change from Baseline to 12 weeks (after intervention)]
  • Mood Assessment [Time frame: Change from Baseline to 12 weeks (after intervention)]
  • Pain in hands and feet [Time frame: Change from Baseline to 12 weeks (after intervention)]
  • Touch Detection Thresholds [Time frame: Change from Baseline to 12 weeks (after intervention)]
  • Handgrip strength test [Time frame: Change from Baseline to 12 weeks (after intervention)]
  • General physical functioning and mobility [Time frame: Change from Baseline to 12 weeks (after intervention)]
  • Body composition [Time frame: Change from Baseline to 12 weeks (after intervention)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Spain · 1 center
  • University of Granada — Granada

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 Cont PMID 35079838

Identifiers

NCT: NCT04652609 · PRESIONA20

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗