Preventing Chemotherapy-induced Peripheral Neuropathy Using PRESIONA Exercise Program
- Conditions
- Breast Neoplasm
- Interventions
- Other: PRESIONA
- Registration Number
- NCT04652609
- Lead Sponsor
- Universidad de Granada
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 25
- 18 years or older
- HER2+ breast cancer diagnosis
- On the waiting list to anticancer medical treatment (taxanes-based neoadjuvant chemotherapy)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PRESIONA 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.
- Primary Outcome Measures
Name Time Method Patient-reported CIPN symptoms 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
Name Time Method CIPN severity 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.
Mood Assessment 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.
Touch Detection Thresholds Change from Baseline to 12 weeks (after intervention) assessed by Semmes-Weinstein filaments (SWMs)
Quality of sleep 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.
Pain in hands and feet 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.
General physical functioning and mobility 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.
Breast cancer quality of life 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.
Handgrip strength test Change from Baseline to 12 weeks (after intervention) assessed by TKK5101 Grp-D dynamometer (Takeya, Tokyo, Japan)
Body composition Change from Baseline to 12 weeks (after intervention) assesseb by bioimpedance (InBody)
Trial Locations
- Locations (1)
University of Granada
🇪🇸Granada, Spain