Chemotherapy Induced Peripheral Neuropathy (CIPN) Clinical Trial
Official title:
Electrical Stimulation and Chemotherapy Induced Peripheral Neuropathy.
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03430999 -
SUNCIST: A Study of Calmangafodipir in Healthy Japanese and Caucasian Subjects
|
Phase 1 | |
| Not yet recruiting |
NCT04715542 -
Stibium Metallicum Praeparatum 6x Versus Placebo in the Prevention of Paclitaxel-induced Peripheral Neurotoxicity
|
Phase 3 |