High Tone Therapy for Chemotherapy Induced Neuropathy | NCT06048471

Studies
High Tone Therapy for Chemotherapy Induced Neuropathy

NCT06048471

Sponsor

Vienna Hospital Association

Status

Completed

Last Update Posted

Oct 10, 2023Actual

Enrollment

14Actual

Phase

Not Applicable

Conditions

Chemotherapy-induced Peripheral Neuropathy
Electrical Stimulation

Interventions

HiTop

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2020Actual

Primary Completion Date

Sep 22, 2023Actual

Completion Date

Sep 22, 2023Actual

First Submitted Date

Mar 2, 2020

First Submission Date that Met QC Criteria

Sep 15, 2023

First Posted Date

Sep 21, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2023

Last Update Posted Date

Oct 10, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Label	Type	Description	Intervention Names
HiTop	Experimental		Other: HiTop
Sham stimulation	Sham Comparator		Other: HiTop

Name	Type	Description	Arm Group Labels	Other Names
HiTop	Other	High tone transcutaneous electrical stimulation	HiTop Sham stimulation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intensity of paresthesia	NRS scale	5 weeks

Secondary Outcomes

Measure	Description	Time Frame
health related Quality of life (QOL), detailed symptroms of neuropathy	EORTC C30, CIPN 20, Neuropathy symptom scale (NSS), NRS scales	5 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Klinik Donaustadt		Vienna		1220	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38280118	Derived	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.