High Tone Therapy for Chemotherapy Induced Neuropathy

Not Applicable

Completed

• Conditions: Electrical Stimulation; Chemotherapy-induced Peripheral Neuropathy
• Interventions: Other: HiTop

• Registration Number: NCT06048471
• Lead Sponsor: Vienna Hospital Association

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 available

Study Timeline

• Study First Submitted: 2020-03-02
• Study Start: 2020-04-01
• Study First Submitted QC: 2023-09-15
• Study First Posted: 2023-09-21
• Primary Completion: 2023-09-22
• Study Completion: 2023-09-22
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-08
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham stimulation	HiTop	-
HiTop	HiTop	-

Primary Outcome Measures

Name	Time	Method
Intensity of paresthesia	5 weeks	NRS scale

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Klinik Donaustadt; 🇦🇹 Vienna, Austria