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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
25
Aerobic and strength exercise combined with restricction blood flow cuffs during chemotherapy treatment
University of Granada
Granada, Spain
RECRUITINGPatient-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.
Time frame: Change from Baseline to 12 weeks (after intervention)
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.
Time frame: Change from baseline to 12 weeks (after intervention)
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.
Time frame: Change from Baseline to 12 weeks (after intervention)
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.
Time frame: Change from Baseline to 12 weeks (after intervention)
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.
Time frame: Change from Baseline to 12 weeks (after intervention)
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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.
Time frame: Change from Baseline to 12 weeks (after intervention)
Touch Detection Thresholds
assessed by Semmes-Weinstein filaments (SWMs)
Time frame: Change from Baseline to 12 weeks (after intervention)
Handgrip strength test
assessed by TKK5101 Grp-D dynamometer (Takeya, Tokyo, Japan)
Time frame: Change from Baseline to 12 weeks (after intervention)
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.
Time frame: Change from Baseline to 12 weeks (after intervention)
Body composition
assesseb by bioimpedance (InBody)
Time frame: Change from Baseline to 12 weeks (after intervention)