Preventing Chemotherapy-induced Peripheral Neuropathy Using PRESIONA Exercise Program

University of Granada (UGR)

Status: Enrolling

Conditions: Breast Neoplasm

Treatments: Other: PRESIONA

Study type: Interventional

Funder types: Other

Identifiers

NCT04652609

PRESIONA20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 2 patient groups

PRESIONA

Experimental group

Description:

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.

Treatment:

Other: PRESIONA

Control group

No Intervention group

Description:

Patients undergoing usual medical treatment