Breast Neoplasm
Conditions
Keywords
Breast neoplasm, Breast cancer, Therapeutic exercise, Small Fiber Neuropathy
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.
Interventions
OTHERPRESIONA
Aerobic and strength exercise combined with restricction blood flow cuffs during chemotherapy treatment
Sponsors
Universidad de Granada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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) |
| 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. |
| Body composition | Change from Baseline to 12 weeks (after intervention) | assesseb by bioimpedance (InBody) |
| Touch Detection Thresholds | Change from Baseline to 12 weeks (after intervention) | assessed by Semmes-Weinstein filaments (SWMs) |
Countries
Spain
Contacts
Primary ContactIrene Cantarero-Villanueva, PhD
Outcome results
None listed