Breast NeoplasmPRESIONANCT04652609
Preventing Chemotherapy-induced Peripheral Neuropathy Using PRESIONA Exercise Program
A study testing PRESIONA in people with Breast Neoplasm, run by Universidad de Granada at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- PRESIONA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2021to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- HER2+ breast cancer diagnosis
- On the waiting list to anticancer medical treatment (taxanes-based neoadjuvant chemotherapy)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
University of Granada
Granada, 18016
Irene Cantarero-Villanueva, PhD, 958248764, irenecantarero@ugr.es
Noelia Galiano-Castillo, Phd
About this study
Official title: Prevention of Chemotherapy-induced Peripheral Neuropathy With Therapeutic Exercise and Blood Flow Restriction Using PRESIONA Program
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.
Read the detailed 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.
- Conditions
- Breast Neoplasm
- Being tested
- PRESIONA
- Keywords
- Breast neoplasm, Breast cancer, Therapeutic exercise, Small Fiber Neuropathy
- Medical subject headings
- Breast Neoplasms, Small Fiber Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRESIONAOther
Also called Experimental group, Therapeutic exercise combined with blood flow restriction
Aerobic and strength exercise combined with restricction blood flow cuffs during chemotherapy treatment
| Study group | Role | What they receive |
|---|---|---|
| PRESIONA | Experimental | 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. Receives: Other: PRESIONA |
| Control group | No intervention | Patients undergoing usual medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline to 12 weeks (after intervention)
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline to 12 weeks (after intervention)
Touch Detection Thresholds
assessed by Semmes-Weinstein filaments (SWMs)
Measured: Change from Baseline to 12 weeks (after intervention)
Handgrip strength test
assessed by TKK5101 Grp-D dynamometer (Takeya, Tokyo, Japan)
Measured: 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.
Measured: Change from Baseline to 12 weeks (after intervention)
Body composition
assesseb by bioimpedance (InBody)
Measured: Change from Baseline to 12 weeks (after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start1 Jan 2021
- Primary completion1 Jan 2025
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irene Cantarero Villanueva, Universidad de Granada
- Investigators
- Irene Cantarero-Villanueva, PhD, Principal investigator, Physical Therapy Deparment, Faculty of Health Sciences, University of Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652609
- Sponsor's protocol ID
- PRESIONA20
- Acronym
- PRESIONA
- Status last verified
- Nov 2025
- First submitted
- 20 Oct 2020
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lopez-Garzon M, Cantarero-Villanueva I, Legeren-Alvarez M, Gallart-Aragon T, Postigo-Martin P, Gonzalez-Santos A, Lozano-Lozano M, Martin-Martin L, Ortiz-Comino L, Castro-Martin E, Ariza-Garcia A, Fernandez-Lao C, Arroyo-Morales M, Galiano-Castillo N. Prevention of Chemotherapy-Induced Peripheral Neuropathy With PRESIONA, a Therapeutic Exercise and Blood Flow Restriction Program: A Randomized Controlled Study Protocol. Phys Ther. 2022 Mar 1;102(3):pzab282. doi: 10.1093/ptj/pzab282.
PubMed 35079838
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Chemotherapy-induced Peripheral Neuropathy With Therapeutic Exercise and Blood Flow Restriction Using PRESIONA Program
- ClinicalTrials.gov ID
- NCT04652609
- Acronym / sponsor ID
- PRESIONA / PRESIONA20
- Conditions
- Breast Neoplasm
- Keywords
- Breast neoplasm, Breast cancer, Therapeutic exercise, Small Fiber Neuropathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 3 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRESIONA | Experimental | Other: PRESIONAAn 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. |
| Control group | No intervention | –Patients undergoing usual medical treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- HER2+ breast cancer diagnosis
- On the waiting list to anticancer medical treatment (taxanes-based neoadjuvant chemotherapy)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRESIONAAlso: Experimental group, Therapeutic exercise combined with blood flow restrictionAerobic and strength exercise combined with restricction blood flow cuffs during chemotherapy treatment | Other | PRESIONA |
Primary outcome
Patient-reported CIPN symptoms
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.
9 secondary outcomes
Breast cancer quality of life
Time frame: Change from baseline to 12 weeks (after intervention)
CIPN severity
Time frame: Change from Baseline to 12 weeks (after intervention)
Quality of sleep
Time frame: Change from Baseline to 12 weeks (after intervention)
Mood Assessment
Time frame: Change from Baseline to 12 weeks (after intervention)
Pain in hands and feet
Time frame: Change from Baseline to 12 weeks (after intervention)
Touch Detection Thresholds
Time frame: Change from Baseline to 12 weeks (after intervention)
Handgrip strength test
Time frame: Change from Baseline to 12 weeks (after intervention)
General physical functioning and mobility
Time frame: Change from Baseline to 12 weeks (after intervention)
Body composition
Time frame: Change from Baseline to 12 weeks (after intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Derived from this study: PubMed 35079838Lopez-Garzon M, Cantarero-Villanueva I, Legeren-Alvarez M, Gallart-Aragon T, Postigo-Martin P, Gonzalez-Santos A, Lozano-Lozano M, Martin-Martin L, Ortiz-Comino L, Castro-Martin E, Ariza-Garcia A, Fernandez-Lao C, Arroyo-Morales M, Galiano-Castillo N. Prevention of Chemotherapy-Induced Peripheral Neuropathy With PRESIONA, a Therapeutic Exercise and Blood Flow Restriction Program: A Randomized Controlled Study Protocol. Phys Ther. 2022 Mar 1;102(3):pzab282. doi: 10.1093/ptj/pzab282.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Irene Cantarero-Villanueva, PhD principal investigator
Physical Therapy Deparment, Faculty of Health Sciences, University of Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRESIONA in people with Breast Neoplasm, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Irene Cantarero-Villanueva, PhD (958248764, irenecantarero@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported CIPN symptoms (time frame: Change from Baseline to 12 weeks (after intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04652609, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.