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
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasm||Other: PRESIONA||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
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.
Aerobic and strength exercise combined with restricction blood flow cuffs during chemotherapy treatment
No Intervention: Control group
Patients undergoing usual medical treatment
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Touch Detection Thresholds [ Time Frame: Change from Baseline to 12 weeks (after intervention) ]assessed by Semmes-Weinstein filaments (SWMs)
- Handgrip strength test [ Time Frame: Change from Baseline to 12 weeks (after intervention) ]assessed by TKK5101 Grp-D dynamometer (Takeya, Tokyo, Japan)
- 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.
- Body composition [ Time Frame: Change from Baseline to 12 weeks (after intervention) ]assesseb by bioimpedance (InBody)
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
|Contact: Irene Cantarero-Villanueva, PhDfirstname.lastname@example.org|
|University of Granada|
|Granada, Spain, 18016|
|Contact: Irene Cantarero-Villanueva, PhD 958248764 email@example.com|
|Sub-Investigator: Noelia Galiano-Castillo, Phd|
|Principal Investigator: Irene Cantarero-Villanueva, Phd|
|Sub-Investigator: María de la Cabeza López-Garzón, MSc|
|Principal Investigator:||Irene Cantarero-Villanueva, PhD||Physical Therapy Deparment, Faculty of Health Sciences, University of Granada|