Preventing Chemotherapy-induced Peripheral Neuropathy Using PRESIONA Exercise Program
ConditionBreast Neoplasm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorUniversidad de Granada
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older
HER2+ breast cancer diagnosis
On the waiting list to anticancer medical treatment (taxanes-based neoadjuvant chemotherapy)
Disqualifiers
Previous diagnosis of cancer
Pregnant
Cardiac pathology
No symptoms or pathology that could be confused with neuropathy or related to diabetes
Trial design
Design model
Parallel
Treatments tested in this trial
PRESIONA
Other interventionAerobic and strength exercise combined with restricction blood flow cuffs during chemotherapy treatment
Treatment groups
25 Participants
are divided into 2 treatment groupsGroup A: PRESIONAExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Change from Baseline to 12 weeks (after intervention)Secondary outcomes
1
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.
Time frame
Change from baseline to 12 weeks (after intervention)2
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.
Time frame
Change from Baseline to 12 weeks (after intervention)3
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.
Time frame
Change from Baseline to 12 weeks (after intervention)4
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.
Time frame
Change from Baseline to 12 weeks (after intervention)Sponsors and contacts
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Source ClinicalTrials.gov