NCT Number: NCT04652609
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.
Interested in participating?
Request Info18 year–70 year
Female
Interventional
Not applicable
Granada, 18016, Spain
Location status: Recruiting
Irene Cantarero-Villanueva, PhD
CONTACT
Irene Cantarero-Villanueva, Phd
PRINCIPAL_INVESTIGATOR
María de la Cabeza López-Garzón, MSc
SUB_INVESTIGATOR
Noelia Galiano-Castillo, Phd
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Aerobic and strength exercise combined with restricction blood flow cuffs during chemotherapy treatment
Other names: Experimental group, Therapeutic exercise combined with blood flow restriction
Time frame: Change from Baseline to 12 weeks (after intervention)
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)
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)
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)
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)
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)
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)
assessed by Semmes-Weinstein filaments (SWMs)
Time frame: Change from Baseline to 12 weeks (after intervention)
assessed by TKK5101 Grp-D dynamometer (Takeya, Tokyo, Japan)
Time frame: Change from Baseline to 12 weeks (after intervention)
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)
assesseb by bioimpedance (InBody)
Contact information is provided by the study sponsor or research team.
Universidad de Granada
Other
Prevention of Chemotherapy-induced Peripheral Neuropathy With Therapeutic Exercise and Blood Flow Restriction Using PRESIONA Program
Acronym: PRESIONA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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