Electrical Stimulation and Chemotherapy Induced Peripheral Neuropathy

Chemotherapy Induced Peripheral Neuropathy (CIPN) Clinical Trial

Official title:

Electrical Stimulation and Chemotherapy Induced Peripheral Neuropathy.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02088996
• Other study ID #: Studie 3
• Status: Active, not recruiting
• Phase: N/A
• First received: March 10, 2014
• Last updated: August 25, 2015
• Start date: March 2011
• Est. completion date: December 2015

Study information

• Verified date: August 2015
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chemotherapy Induced Peripheral Neuropathy (CIPN)
• Peripheral Nervous System Diseases

Intervention

Device:
• longwave diathermy on high power and interferential therapy

• longwave diathermy on low power

Locations

Country	Name	City	State
Sweden	Västmanlands sjukhus, Västerås, Onkologiska kliniken	Västerås

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in balance ability/disability from baseline	Romberg test (standing with both ankle bones touching each other with the hands crossed and touching the shoulders, max time 30 seconds) as well as, tightened Romberg test (tandem standing with with the hands crossed and touching the shoulders, max 60 seconds).; One-legged stance test (standing on one leg with the hands crossed and touching the shoulders, max 30 seconds). These tests have good validity and reliability when tested on healthy elderly females.; The patient had three attempts of each test of which the best attempt was recorded. All tests were performed with open and closed eyes. The time was stopped when the patient moved the feet/arms position and/or looked when the eyes should be closed.	baseline and 12 weeks	Yes
Other	Change in quality of life from baseline	Generic health-related quality of life was measured by the European quality of life questionnaire (EQ-5D). The following 5 dimensions are measured: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problem, some problems, extreme problems. (EuroQol-Group, 1990). EQ-5D has shown good reliability and validity when tested in older people (Haywood, Garratt, Fitzpatrick, 2005).	baseline and 12 weeks	Yes
Other	Change in expectations from baseline	Expectations of treatment outcome were evaluated before treatment started on a numerical scale (0-100). The question asked to the patients was: What is your expectation of treatment effect with electroconvulsive therapy at CIPN for spreading of numbness, pain, discomfort, subjective experienced balance and balance? Background data such as age, sex, diagnosis, chemotherapy variety, when chemotherapy started and completed were recorded before treatment.	baseline and 12 weeks	Yes
Other	Change in balance ability/disability from baseline	Measurement of subjective experience of balance Dizziness Handicap Inventory was used for measurement of patients experience ot their balance. The questionnaire contains 25 questions and has good reliability in vestibular disorders/disabilities. In this study , however the form was abbreviated and contained only 15 questions, ten questions were omitted since they were considered to be inappropriate for this patient group.; Activities-Specific Balance Confidence Scale (ABC) is a subjective measure of confidence in performing various ambulatory activities without falling. It is a 16-item self-report measure in which patients rate their balance confidence in performing several activities. Each item is rated on a 0-100 scale. Zero represents no confidence; a score of 100 represents complete confidence. The instrument is validated and demonstrated good test-retest reliability on elderly persons.	baseline and 12 weeks	Yes
Other	Change in balance ability/disability from baseline	Romberg test (standing with both ankle bones touching each other with the hands crossed and touching the shoulders, max time 30 seconds) as well as, tightened Romberg test (tandem standing with with the hands crossed and touching the shoulders, max 60 seconds).; One-legged stance test (standing on one leg with the hands crossed and touching the shoulders, max 30 seconds). These tests have good validity and reliability when tested on healthy elderly females.; The patient had three attempts of each test of which the best attempt was recorded. All tests were performed with open and closed eyes. The time was stopped when the patient moved the feet/arms position and/or looked when the eyes should be closed.	baseline and 12 weeks	Yes
Other	Change in quality of life from baseline	Generic health-related quality of life was measured by the European quality of life questionnaire (EQ-5D). The following 5 dimensions are measured: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problem, some problems, extreme problems. (EuroQol-Group, 1990). EQ-5D has shown good reliability and validity when tested in older people (Haywood, Garratt, Fitzpatrick, 2005).	baseline and 6 months	Yes
Other	Change in expectations from baseline	Expectations of treatment outcome were evaluated before treatment started on a numerical scale (0-100). The question asked to the patients was: What is your expectation of treatment effect with electroconvulsive therapy at CIPN for spreading of numbness, pain, discomfort, subjective experienced balance and balance? Background data such as age, sex, diagnosis, chemotherapy variety, when chemotherapy started and completed were recorded before treatment.	baseline and 6 months	Yes
Other	Change in balance ability/disability from baseline	Measurement of subjective experience of balance Dizziness Handicap Inventory was used for measurement of patients experience ot their balance. The questionnaire contains 25 questions and has good reliability in vestibular disorders/disabilities. In this study , however the form was abbreviated and contained only 15 questions, ten questions were omitted since they were considered to be inappropriate for this patient group.; Activities-Specific Balance Confidence Scale (ABC) is a subjective measure of confidence in performing various ambulatory activities without falling. It is a 16-item self-report measure in which patients rate their balance confidence in performing several activities. Each item is rated on a 0-100 scale. Zero represents no confidence; a score of 100 represents complete confidence. The instrument is validated and demonstrated good test-retest reliability on elderly persons.	baseline and 6 months	Yes
Primary	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	Yes
Secondary	Change in pain intensity and discomfort from baseline .	Numerical rating scale (NRS) were used for measuring the intensity of pain. This is a reliable instrument and has been validated for patients with cancer. Patients rate their pain from zero to 100, with zero reflecting no pain and 100 reflecting the worst possible pain. Discomfort is defined as uncomfortable not knowing where your feet are in relation to the room and met with NRS.	baseline and 12 weeks	Yes
Secondary	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 6 months	Yes
Secondary	Change in pain intensity and discomfort from baseline	Numerical rating scale (NRS) were used for measuring the intensity of pain. This is a reliable instrument and has been validated for patients with cancer. Patients rate their pain from zero to 100, with zero reflecting no pain and 100 reflecting the worst possible pain. Discomfort is defined as uncomfortable not knowing where your feet are in relation to the room and met with NRS.	baseline and 6 months	Yes