Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
14 participants
INTERVENTIONAL
2020-04-01
2023-09-22
Brief Summary
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Patients with neuropathy suffer from sensory disturbances as tingling, numbness, burning pain or sleep disturbances and even though numerous drugs are available, it is still difficult to sufficiently control these Symptoms.
High tone therapy / high tone external muscle stimulation (HTEMS) seems to be an effective treatment for neuropathic symptoms. Previous studies observed promising results in diabetics and chronic kidney disease (CKD) patients.
To date, there is no investigation on HTEMS in patients with chemotherapy induced neuropathy.
Therefore, this aim of this project is to test if HTEMS would bring about a stronger decrease in neuropathic symptoms in this specific patient group, compared to a placebo treatment.
The primary objective is the alleviation of paresthesias. The secondary objective focuses on detailed symptoms of neuropathiy as well as on health-related quality of life.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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HiTop
HiTop
High tone transcutaneous electrical stimulation
Sham stimulation
HiTop
High tone transcutaneous electrical stimulation
Interventions
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HiTop
High tone transcutaneous electrical stimulation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Vienna Hospital Association
OTHER_GOV
Responsible Party
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Locations
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Klinik Donaustadt
Vienna, , Austria
Countries
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References
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Wakolbinger-Habel R, Reinweber M, Alakraa M, Riener I, Scheffold BE, Racz K, Selimi F, Straub C, Jauker J, Bily W, Niedersuss-Beke D, Mayrhofer K, Paternostro-Sluga T. Home-based high tone therapy may alleviate chemotherapy-induced neuropathic symptoms in patients with colorectal cancer: A randomized double-blind placebo-controlled pilot evaluation. Support Care Cancer. 2024 Jan 27;32(2):134. doi: 10.1007/s00520-024-08331-7.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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HiTop Protocol v.1.3
Identifier Type: -
Identifier Source: org_study_id
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