Clinical trial NCT04652609: Preventing Chemotherapy-induced Peripheral Neuropathy Using PRESIONA Exercise Program
Official title: Prevention of Chemotherapy-induced Peripheral Neuropathy With Therapeutic Exercise and Blood Flow Restriction Using PRESIONA Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Neoplasm
Keywords: Breast neoplasm
Breast cancer
Therapeutic exercise
Small Fiber Neuropathy
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

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

Primary outcomes:
measure: Patient-reported CIPN symptoms
timeFrame: Change from Baseline to 12 weeks (after intervention)
Secondary outcomes:
measure: Breast cancer quality of life
timeFrame: Change from baseline to 12 weeks (after intervention)
measure: CIPN severity
timeFrame: Change from Baseline to 12 weeks (after intervention)
measure: Quality of sleep
timeFrame: Change from Baseline to 12 weeks (after intervention)
measure: Mood Assessment
timeFrame: Change from Baseline to 12 weeks (after intervention)
measure: Pain in hands and feet
timeFrame: Change from Baseline to 12 weeks (after intervention)
measure: Touch Detection Thresholds
timeFrame: Change from Baseline to 12 weeks (after intervention)
measure: Handgrip strength test
timeFrame: Change from Baseline to 12 weeks (after intervention)
measure: General physical functioning and mobility
timeFrame: Change from Baseline to 12 weeks (after intervention)
measure: Body composition
timeFrame: Change from Baseline to 12 weeks (after intervention)
Other outcomes:
Locations:
city: Granada
country: Spain
facility: University of Granada
Study officials:
affiliation: Physical Therapy Deparment, Faculty of Health Sciences, University of Granada
name: Irene Cantarero-Villanueva, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.