High Tone Therapy for Chemotherapy-induced Neuropathy in Breast Cancer Patients

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• \- 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)

Locations
Other Locations
Austria
Clinics Donaustadt, Ottakring, Hietzing
RECRUITING
Vienna
Contact Information
Primary
Robert Wakolbinger-Habel, MD, PhD
robert.wakolbinger-habel@gesundheitsverbund.at
+43 1 28802 4604
Backup
Brigitte E Scheffold, MD, MSc, MSc
brigitteelisabeth.scheffold@gesundheitsverbund.at
+43 1 28802 4604
Time Frame
Start Date: 2023-11-03
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 160
Treatments
Experimental: Verum group
Placebo_comparator: Placebo group
Related Therapeutic Areas
Sponsors
Leads: Vienna Hospital Association

This content was sourced from clinicaltrials.gov