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.

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Key information

Conditions

Chemotherapy-induced Peripheral Neuropathy Electrical Stimulation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik Donaustadt

Vienna, 1220, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HiTop

Other

High tone transcutaneous electrical stimulation

Primary outcomes

Intensity of paresthesia

Time frame: 5 weeks

NRS scale

Secondary outcomes

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

Time frame: 5 weeks

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

Sponsors and collaborators

Lead sponsor

Vienna Hospital Association

Other Gov

Registry information

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2023
First posted: Sep 21, 2023
Registry last updated: Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed