Clinical trial NCT02088996: Electrical Stimulation and Chemotherapy Induced Peripheral Neuropathy
Official title: Electrical Stimulation and Chemotherapy Induced Peripheral Neuropathy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chemotherapy Induced Peripheral Neuropathy (CIPN)
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2014-03-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chemotherapy-induced peripheral neuropathy (CIPN) implies sensory or deficits pain, loss of motor functions and impaired proprioception which in turn may affect balance and fine motor skills. It is mainly subjected to the peripheral parts of the extremities, may be transient or permanent.CIPN is a common, potentially severe and often dose-limiting side effect after patient exposure of numerous classes of antineoplastic agents including platins, taxanes, vinca alkaloids, bortezomib and thalidomide. At present, no evidence based treatment of CIPN is available. A variety of different drugs or drug combinations have been clinically tested but the value of these treatments is uncertain. Many patients with CIPN are referred to physiotherapy but still this treatment is more based on clinical experience and tradition than scientific evidence. In a nonrandomized study, sensory electrical stimulation(MC5-A Calmare ®) was tested on 16 persons.The electrodes were placed on the hand and foot and intensity was gradually increased and given daily for 10 days. Pain was reduced 20% in numeric pain score for 15 of the 16 participating patients.

Our clinical experience indicates that treatment with long wave diathermy (LWD) may decrease CIPN symptoms. This treatment produces electromagnetic radiation according the capacitor method with heightened circulation and heat which is assumed to reduce pain. Interferential Therapy (IT) is an electro-physical method which is based on an electric field in the painful area through four electrodes or vacuum cups placed on the skin. Increased blood circulation and pain relief is supposed to be achieved. IT use two different intermediate frequencies (1001-10000 Hz) alternating currents in the painful area. The treatment effect correspond to the "gate control-theory"; inhibition of pain signals in small diameter fibers by activity in large-diameter Aβ-fibers by spinal neurons. Some studies have shown effect in treating pain with interferential currents when pain is experimentally induced or induced by cold in otherwise pain-free volunteers, when compared to a control or placebo.

The hypothesis of this study is that the combination therapy longwave diathermy on high power and interferential currents gives better results than longwave diathermy on low power.

Detailed description: A randomized controlled trial to investigate the effects of combination therapy longwave diathermy on high power and interferential currents, as compared to longwave diathermy at low power (control group) for sensory and motor symptoms in patients with CIPN in the feet and lower legs. Sensory and motor symptoms are defined as numbness, pain, discomfort and balance impairment.

Interferential currents is administered by "Electrostimulation unit ES-520 \& Vacuum Unit.

The longwave diathermy at low and high power is given thru capacitive energy transfer system and is administered by "Skanlab 25 Bodywave".

The drugs that have been clinically tested in other studies were magnesium, calcium, vitamin E and B6, glutamine, glutathione, n-acetyl cysteine omega-3 fatty acids, acetyl-L-carnitine and alpha lipoic acid.

Eligibility criteria: Inclusion Criteria:

- patients over 18 years who received chemotherapy and had documented side effects such as numbness, tingling, pain or swelling sensation in the feet/lower legs.

Exclusion Criteria:

* pregnancy, thrombosis thrombophlebitis in the feet or lower legs, muscle cramps, acute bleeding disorders, dementia, type 1 diabetes mellitus, open sores on the feet or lower legs, peripheral sensory neuropathies due to causes other than chemotherapy, ongoing chemotherapy with drugs known to cause CIPN.

Primary outcomes:
measure: Change in numbness from baseline
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: Change in pain intensity and discomfort from baseline .
timeFrame: baseline and 12 weeks
measure: Change in numbness from baseline
timeFrame: baseline and 6 months
measure: Change in pain intensity and discomfort from baseline
timeFrame: baseline and 6 months
Other outcomes:
measure: Change in balance ability/disability from baseline
timeFrame: baseline and 12 weeks
measure: Change in quality of life from baseline
timeFrame: baseline and 12 weeks
measure: Change in expectations from baseline
timeFrame: baseline and 12 weeks
measure: Change in balance ability/disability from baseline
timeFrame: baseline and 12 weeks
measure: Change in balance ability/disability from baseline
timeFrame: baseline and 12 weeks
measure: Change in quality of life from baseline
timeFrame: baseline and 6 months
measure: Change in expectations from baseline
timeFrame: baseline and 6 months
measure: Change in balance ability/disability from baseline
timeFrame: baseline and 6 months
Locations:
city: Västerås
country: Sweden
facility: Västmanlands sjukhus, Västerås, Onkologiska kliniken
Study officials:
affiliation: Västmanlands sjukhus, Västerås
name: Inger Andreasson, MD
role: PRINCIPAL_INVESTIGATOR
References: