High Tone Therapy for Chemotherapy Induced Neuropathy

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.

Study Overview

• Status: Completed
• Conditions: Electrical Stimulation; Chemotherapy-induced Peripheral Neuropathy
• Intervention / Treatment: Other: HiTop

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tatjana Paternostro-Sluga, Prof.; Phone Number: +431288024603; Email: tatjana.paternostro-sluga@wienkav.at
• Study Contact Backup: Name: Robert Wakolbinger, MD PhD; Phone Number: +431288024603; Email: robert.wakolbinger@wienkav.at

Study Locations

• Austria
  • Vienna, Austria, 1220
    • Klinik Donaustadt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham stimulation	Other: HiTop; High tone transcutaneous electrical stimulation
Experimental: HiTop	Other: HiTop; High tone transcutaneous electrical stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of paresthesia	NRS scale	5 weeks

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Vienna Hospital Association

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): September 22, 2023
• Study Completion (Actual): September 22, 2023

Study Registration Dates

• First Submitted: March 2, 2020
• First Submitted That Met QC Criteria: September 15, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 8, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: HiTop Protocol v.1.3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No