Electrical Stimulation and Chemotherapy Induced Peripheral Neuropathy

NCT02088996 | Unknown

• 1 other identifier: Studie 3
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy Induced Peripheral Neuropathy (CIPN)

Outcome Measures

Primary Outcomes (1)

• Change in numbness from baseline

  The definition of spreading of numbness was pins and needles, tingling and parasthesias. Patients were asked to draw the distribution of their numbness in their legs and feet on a sketch, -which was constructed based on pain drawing sketch.

  baseline and 12 weeks

Secondary Outcomes (3)

• Change in pain intensity and discomfort from baseline .

  baseline and 12 weeks

• Change in numbness from baseline

  baseline and 6 months

• Change in pain intensity and discomfort from baseline

  baseline and 6 months

Other Outcomes (7)

• Change in balance ability/disability from baseline

  baseline and 12 weeks

• Change in quality of life from baseline

  baseline and 12 weeks

• Change in expectations from baseline

  baseline and 12 weeks

Study Arms (2)

IT and LWD on high power

ACTIVE COMPARATOR

IT and LWD on high power

Device: longwave diathermy on high power and interferential therapy

LWD on low power

PLACEBO COMPARATOR

LWD on low power

Device: longwave diathermy on low power

Interventions

longwave diathermy on high power and interferential therapy DEVICE

IT and LWD on high power

longwave diathermy on low power DEVICE

LWD on low power

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Västmanlands sjukhus, Västerås, Onkologiska kliniken

Västerås, 72224, Sweden

Location

Study Officials

• Inger Andreasson, MD

  Västmanlands sjukhus, Västerås

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2014
• First Posted: March 17, 2014
• Study Start: March 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 26, 2015

Record last verified: 2015-08

Locations

SE (1)