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Preventing Chemotherapy-induced Peripheral Neuropathy Using PRESIONA Exercise Program (PRESIONA)

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ClinicalTrials.gov Identifier: NCT04652609
Recruitment Status : Not yet recruiting
First Posted : December 3, 2020
Last Update Posted : December 3, 2020
Sponsor:
Information provided by (Responsible Party):
Irene Cantarero Villanueva, Universidad de Granada

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Breast Neoplasm Other: PRESIONA Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Chemotherapy-induced Peripheral Neuropathy With Therapeutic Exercise and Blood Flow Restriction Using PRESIONA Program
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: PRESIONA
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
Aerobic and strength exercise combined with restricction blood flow cuffs during chemotherapy treatment
Other Names:
  • Experimental group
  • Therapeutic exercise combined with blood flow restriction
No Intervention: Control group
Patients undergoing usual medical treatment


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Breast cancer quality of life [ 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.

  2. CIPN severity [ 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.

  3. Quality of sleep [ 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.

  4. Mood Assessment [ 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.

  5. Pain in hands and feet [ 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.

  6. Touch Detection Thresholds [ Time Frame: Change from Baseline to 12 weeks (after intervention) ]
    assessed by Semmes-Weinstein filaments (SWMs)

  7. Handgrip strength test [ Time Frame: Change from Baseline to 12 weeks (after intervention) ]
    assessed by TKK5101 Grp-D dynamometer (Takeya, Tokyo, Japan)

  8. General physical functioning and mobility [ 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.

  9. Body composition [ Time Frame: Change from Baseline to 12 weeks (after intervention) ]
    assesseb by bioimpedance (InBody)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04652609


Contacts
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Contact: Irene Cantarero-Villanueva, PhD 958248764 irenecantarero@ugr.es

Locations
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Spain
University of Granada
Granada, Spain, 18016
Contact: Irene Cantarero-Villanueva, PhD    958248764    irenecantarero@ugr.es   
Sub-Investigator: Noelia Galiano-Castillo, Phd         
Principal Investigator: Irene Cantarero-Villanueva, Phd         
Sub-Investigator: María de la Cabeza López-Garzón, MSc         
Sponsors and Collaborators
Universidad de Granada
Investigators
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Principal Investigator: Irene Cantarero-Villanueva, PhD Physical Therapy Deparment, Faculty of Health Sciences, University of Granada
More Information
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Responsible Party: Irene Cantarero Villanueva, Principal Investigator, Universidad de Granada
ClinicalTrials.gov Identifier: NCT04652609    
Other Study ID Numbers: PRESIONA20
First Posted: December 3, 2020    Key Record Dates
Last Update Posted: December 3, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Irene Cantarero Villanueva, Universidad de Granada:
Breast neoplasm
Breast cancer
Therapeutic exercise
Small Fiber Neuropathy
Additional relevant MeSH terms:
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Breast Neoplasms
Peripheral Nervous System Diseases
Neoplasms
Neuromuscular Diseases
 Nervous System Diseases
Neoplasms by Site
Breast Diseases
Skin Diseases