Status:
COMPLETED
High Tone Therapy for Chemotherapy Induced Neuropathy
Lead Sponsor:
Vienna Hospital Association
Conditions:
Chemotherapy-induced Peripheral Neuropathy
Electrical Stimulation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Chemotherapy-induced peripheral neuropathy (CIPN), a side effect of antineoplastic medication, was reported to occur in about 68% of the patients receiving chemotherapy. CIPN does not only limit quali...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients with histologically verified colorectal cancer and adjuvant treatment with a platin derivate (e.g., cisplatin, oxaliplatin): 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
- Stable medication (no changes of especially pain medication during the study)
- 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 or higher on the Numeric Rating Scale (NRS)
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2023
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06048471
Start Date
April 1 2020
End Date
September 22 2023
Last Update
October 10 2023
Active Locations (1)
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1
Klinik Donaustadt
Vienna, Austria, 1220