Back to resultsPreventing Chemotherapy-induced Peripheral Neuropathy Using PRESIONA Exercise Program (PRESIONA)
Primary Purpose
Breast Neoplasm
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
PRESIONA
Sponsored by
About this trial
This is an interventional prevention trial for Breast Neoplasm focused on measuring Breast neoplasm, Breast cancer, Therapeutic exercise, Small Fiber Neuropathy
Eligibility 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
Sites / Locations
- University of GranadaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
PRESIONA
Control group
Arm Description
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.
Patients undergoing usual medical treatment
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Touch Detection Thresholds
assessed by Semmes-Weinstein filaments (SWMs)
Handgrip strength test
assessed by TKK5101 Grp-D dynamometer (Takeya, Tokyo, Japan)
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.
Body composition
assesseb by bioimpedance (InBody)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04652609
Brief Title
Preventing Chemotherapy-induced Peripheral Neuropathy Using PRESIONA Exercise Program
Acronym
PRESIONA
Official Title
Prevention of Chemotherapy-induced Peripheral Neuropathy With Therapeutic Exercise and Blood Flow Restriction Using PRESIONA Program
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm
Keywords
Breast neoplasm, Breast cancer, Therapeutic exercise, Small Fiber Neuropathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PRESIONA
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients undergoing usual medical treatment
Intervention Type
Other
Intervention Name(s)
PRESIONA
Other Intervention Name(s)
Experimental group, Therapeutic exercise combined with blood flow restriction
Intervention Description
Aerobic and strength exercise combined with restricction blood flow cuffs during chemotherapy treatment
Primary Outcome Measure Information:
Title
Patient-reported CIPN symptoms
Description
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)
Secondary Outcome Measure Information:
Title
Breast cancer quality of life
Description
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)
Title
CIPN severity
Description
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)
Title
Quality of sleep
Description
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)
Title
Mood Assessment
Description
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)
Title
Pain in hands and feet
Description
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)
Title
Touch Detection Thresholds
Description
assessed by Semmes-Weinstein filaments (SWMs)
Time Frame
Change from Baseline to 12 weeks (after intervention)
Title
Handgrip strength test
Description
assessed by TKK5101 Grp-D dynamometer (Takeya, Tokyo, Japan)
Time Frame
Change from Baseline to 12 weeks (after intervention)
Title
General physical functioning and mobility
Description
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)
Title
Body composition
Description
assesseb by bioimpedance (InBody)
Time Frame
Change from Baseline to 12 weeks (after intervention)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irene Cantarero-Villanueva, PhD
Phone
958248764
Email
irenecantarero@ugr.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irene Cantarero-Villanueva, PhD
Organizational Affiliation
Physical Therapy Deparment, Faculty of Health Sciences, University of Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Granada
City
Granada
ZIP/Postal Code
18016
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irene Cantarero-Villanueva, PhD
Phone
958248764
Email
irenecantarero@ugr.es
First Name & Middle Initial & Last Name & Degree
Noelia Galiano-Castillo, Phd
First Name & Middle Initial & Last Name & Degree
Irene Cantarero-Villanueva, Phd
First Name & Middle Initial & Last Name & Degree
María de la Cabeza López-Garzón, MSc
12. IPD Sharing Statement
Citations:
PubMed Identifier
35079838
Citation
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.
Results Reference
derived
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Preventing Chemotherapy-induced Peripheral Neuropathy Using PRESIONA Exercise Program
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