Preventing Chemotherapy-induced Peripheral Neuropathy Using PRESIONA Exercise Program

Breast Neoplasm Clinical Trial

— PRESIONA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04652609
• Other study ID #: PRESIONA20
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: January 1, 2027

Study information

• Verified date: May 2023
• Source: Universidad de Granada
• Contact: Irene Cantarero-Villanueva, PhD
• Phone: 958248764
• Email: irenecantarero[@]ugr.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms
• Peripheral Nervous System Diseases

Intervention

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

Locations

Country	Name	City	State
Spain	University of Granada	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Breast cancer quality of life	assessed by European Organization for Research and Treatment of Breast Cancer-Specific Quality of Life Questionnaire. The total questionnaire has a score from 0 to 100, in which a higher score indicates increased quality of life.	Change from baseline to 12 weeks (after intervention)
Secondary	CIPN severity	assessed by clinical version of The Total Neuropathy Score. Each item is scored from 0 to 4, with the total score ranging from 0 to 24 points; a higher score indicates greater neuropathy severity.	Change from Baseline to 12 weeks (after intervention)
Secondary	Quality of sleep	assessed by Pittsburgh Sleep Quality Index that is a self-rated questionnaire which assesses sleep quality and disturbances. The global score, with a range of 0-21 points, "0" indicating no difficulty and "21" indicating severe difficulties.	Change from Baseline to 12 weeks (after intervention)
Secondary	Mood Assessment	assessed by Scale for Mood Assessment. The scale tries to assess four moods; anxiety, angerhostility, sadness-depression, and happiness. Itd subscale is scory from 0 to 10, a higher score in the EVEA subscales would indicate that the respondent has a higher level of sad-depressed, anxious, angryhostile, and happy mood, respectively.	Change from Baseline to 12 weeks (after intervention)
Secondary	Pain in hands and feet	assessed by visual analogue scale. From 0 to 10, a higher score is a worse subjective pain in hands and feet.	Change from Baseline to 12 weeks (after intervention)
Secondary	Touch Detection Thresholds	assessed by Semmes-Weinstein filaments (SWMs)	Change from Baseline to 12 weeks (after intervention)
Secondary	Handgrip strength test	assessed by TKK5101 Grp-D dynamometer (Takeya, Tokyo, Japan)	Change from Baseline to 12 weeks (after intervention)
Secondary	General physical functioning and mobility	assessed by the 6 minutes walking test. A greater distance (meters) covered over 6 min indicates greater mobility and general functioning.	Change from Baseline to 12 weeks (after intervention)
Secondary	Body composition	assesseb by bioimpedance (InBody)	Change from Baseline to 12 weeks (after intervention)