Chemotherapy-induced Peripheral Neuropathy
Conditions
Brief summary
The HiToP ® 191 PNP an certified device licensed for the treatment of neuropathia. The home-based treatment is to be performed only in accordance with the approved Investigational Plan (CIP) on subjects who have signed an informed consent form. Device use is limited to the approved study investigators. The study is multicenter, randomized, double-blind, and placebo-controlled. Primary Objective: Comparison of the change of paresthesias from baseline until end of therapy between the two patient groups, assessed by questionnaires Secondary Objectives: Further symptoms of neuropathy as well as on health-related quality of life.
Interventions
DEVICEHiToP 191 PNP
High tone therapy
DEVICEPlacebo device
Placebo therapy
Sponsors
Vienna Hospital Association
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Multicenter, randomized, double-blind, placebo-controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \- Patients with histologically verified breast cancer and neoadjuvant or adjuvant treatment with a taxane derivate (e.g., Paclitaxel, Docetaxel): This group was chosen due to relatively high risk of neuropathy due to this special therapeutic agent 1,9. * Cumulative dose of at least 3 cycles * Interval of 2 weeks since the last chemotherapeutic cycle in order to prevent false worsenings due to delayed neurotoxic effects * Life expectancy of at least 3 months * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2 (that is, the capability to walk and to spend less than 50% of waking hours sitting or lying) * Ability to walk (with or without aids) * European Organisation for Research and Treatment of Cancer (EORTC) common toxicity criteria (CTC) peripheral sensory neuropathy grade 1 or 2 * Intensity of paresthesias of \> 3/10 on the Visual Analog Scale (VAS)
Exclusion criteria
* \- Prevalent neuropathy of different etiology * Serious central-neurological or psychiatric disorder that would interfer with a proper order of the study, according to the judgement of the investigators * Epilepsy * Minors or persons unable to give informed consent * Current neurotoxic medication * Implanted pacemakers or defibrillators * Pregnancy * Wounds in the area to be treated, acute local or systemic infection * Peripheral arterial occlusive disease \> grade 2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alleviation of paresthesias (VAS) | baseline vs. one day after the last treatment session | Visual analog scale, 0-10, higher score = worse |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Further neuropathic symptoms (via VAS questionnaire) | baseline vs. one day after the last treatment session vs. follow-up 2 weeks after the last treatment session | e.g., intensity of tightness, cramps, 0-10, higher score = worse |
| Further neuropathic symptoms (via EORCT CIPN20 questionnaire) | baseline vs. one day after the last treatment session vs. follow-up 2 weeks after the last treatment session | sensory, motor and autonomic scale, 1-4, higher score = worse |
| Quality of life (via EORCT C30 questionnaire) | baseline vs. one day after the last treatment session vs. follow-up 2 weeks after the last treatment session | global health status, physical function, symptom scales, 1-4, higher score = worse |
Countries
Austria
Contacts
Primary ContactRobert Wakolbinger-Habel, MD, PhD
Backup ContactBrigitte E Scheffold, MD, MSc, MSc
Outcome results
None listed