Preventing Chemotherapy-induced Peripheral Neuropathy Using PRESIONA Exercise Program

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2027-01-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Breast Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

PRESIONA

Intervention Type OTHER

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

Control group

Patients undergoing usual medical treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PRESIONA

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

Intervention Type OTHER

Other Intervention Names

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Experimental group Therapeutic exercise combined with blood flow restriction

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No