An interventional study of PRESIONA in Breast Neoplasm, sponsored by Universidad de Granada. Recruiting at 1 site in Spain. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-11-18.
Sponsored by Universidad de Granada · Not applicable, Interventional, and Prevention
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 25 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Universidad de Granada is the lead sponsor of 246 studies on the registry; 43 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An adapted therapeutic exercise program using blood flow restriction cuff perfomed during chemotherapy treatment. 24-36 sessions of 1 hour multimodal components: aerobic, strength and fascial release exercises. Frequency will be adapted to the recovery status of each patient.
Other: PRESIONA
Patients undergoing usual medical treatment
Aerobic and strength exercise combined with restricction blood flow cuffs during chemotherapy treatment
Also known as: Experimental group, Therapeutic exercise combined with blood flow restriction
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.
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)
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)
Ran from Jan 2021 to primary completion in Jan 2025, 48 months.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's 48 months is above that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
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