NCT04652609

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Jan 2021Jan 2027

First Submitted

Initial submission to the registry

October 20, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 3, 2020

Completed
29 days until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

4 years

First QC Date

October 20, 2020

Last Update Submit

November 15, 2025

Conditions

Breast Neoplasm

Keywords

Breast neoplasmBreast cancerTherapeutic exerciseSmall Fiber Neuropathy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Breast cancer quality of life

    Change from baseline to 12 weeks (after intervention)

  • CIPN severity

    Change from Baseline to 12 weeks (after intervention)

  • Quality of sleep

    Change from Baseline to 12 weeks (after intervention)

  • Mood Assessment

    Change from Baseline to 12 weeks (after intervention)

  • Pain in hands and feet

    Change from Baseline to 12 weeks (after intervention)

  • +4 more secondary outcomes

Study Arms (2)

PRESIONA

EXPERIMENTAL

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

Control group

NO INTERVENTION

Patients undergoing usual medical treatment

Interventions

PRESIONAOTHER

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

Also known as: Experimental group, Therapeutic exercise combined with blood flow restriction
PRESIONA

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • HER2+ breast cancer diagnosis
  • On the waiting list to anticancer medical treatment (taxanes-based neoadjuvant chemotherapy)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Granada

Granada, 18016, Spain

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35079838DERIVED

MeSH Terms

Conditions

Breast NeoplasmsSmall Fiber Neuropathy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Irene Cantarero-Villanueva, PhD

    Physical Therapy Deparment, Faculty of Health Sciences, University of Granada

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene Cantarero-Villanueva, PhD

CONTACT

958248764irenecantarero@ugr.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 20, 2020

First Posted

December 3, 2020

Study Start

January 1, 2021

Primary Completion

January 1, 2025

Study Completion (Estimated)

January 1, 2027

Last Updated

November 18, 2025

Record last verified: 2025-11

Locations

ES(1)