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CompletedNCT06048471Updated Oct 10, 2023

High Tone Therapy for Chemotherapy Induced Neuropathy

An interventional study of HiTop in Chemotherapy-induced Peripheral Neuropathy and Electrical Stimulation, sponsored by Vienna Hospital Association. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-10.

Sponsored by Vienna Hospital Association · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 quality of life due to neuropathic symptoms but also may lead to dose reductions or premature interruption of therapy and thus to suboptimal cancer treatment.

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.

02

Conditions studied

  • Chemotherapy-induced Peripheral Neuropathy
  • Electrical Stimulation
03

In context

Peripheral Nervous System Diseases

1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.

This study's enrollment of 14 is below the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.

Browse Peripheral Nervous System Diseases studies →

Lead sponsor

Vienna Hospital Association is the lead sponsor of 10 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    HiTop

    Other: HiTop

  • Sham comparator
    Sham stimulation

    Other: HiTop

Interventions

  • OtherHiTop

    High tone transcutaneous electrical stimulation

06

What researchers measure

Primary outcomes

  1. Intensity of paresthesia

    NRS scale

    Time frame: 5 weeks

Secondary outcomes

  1. health related Quality of life (QOL), detailed symptroms of neuropathy

    EORTC C30, CIPN 20, Neuropathy symptom scale (NSS), NRS scales

    Time frame: 5 weeks

07

Study locations

1 site
  • Klinik Donaustadt
    Vienna, 1220, Austria
08

References and documents

Study documents

  • Study protocol · Sep 1, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06048471
Lead sponsor
Vienna Hospital Association
Responsible party
Sponsor
First posted
Sep 21, 2023
Start date
Apr 1, 2020
Primary completion
Sep 22, 2023
Completion
Sep 22, 2023
Last update
Oct 10, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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