High Tone Therapy for Chemotherapy Induced Neuropathy

Vienna Hospital Association

Status

Completed

Conditions

Electrical Stimulation

Chemotherapy-induced Peripheral Neuropathy

Treatments

Other: HiTop

Study type

Interventional

Funder types

Other

Identifiers

NCT06048471

HiTop Protocol v.1.3

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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