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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04652609
Other study ID # PRESIONA20
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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