Home-based treatment for chemotherapy-induced nerve pain
High Tone Therapy for Chemotherapy-induced Neuropathy in Breast Cancer Patients
This study is testing if a new device can help breast cancer patients with nerve pain caused by chemotherapy feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vienna Hospital Association Government |
| Locations | 1 site (Vienna) |
| Trial ID | NCT06132776 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the HiToP 191 PNP device in treating chemotherapy-induced peripheral neuropathy in patients with breast cancer. It is a multicenter, randomized, double-blind, and placebo-controlled trial, where participants will be assigned to receive either the active device or a placebo. The primary objective is to compare changes in nerve pain symptoms from baseline to the end of therapy, assessed through questionnaires. Secondary objectives include evaluating additional neuropathy symptoms and overall health-related quality of life.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically verified breast cancer who have received taxane-based chemotherapy and experience moderate nerve pain.
Not a fit: Patients with neuropathy from other causes or those with severe central nervous system disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate nerve pain for patients undergoing chemotherapy.
How similar studies have performed: While similar approaches have been explored, this specific device and its application in this context are relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Vienna
- Clinics Donaustadt, Ottakring, Hietzing — Vienna, Austria (Recruiting)
Study contacts
- Study coordinator: Robert Wakolbinger-Habel, MD, PhD
- Email: robert.wakolbinger-habel@gesundheitsverbund.at
- Phone: +43 1 28802 4604
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.