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High Tone Therapy for Chemotherapy Induced Neuropathy

Primary Purpose

Chemotherapy-induced Peripheral Neuropathy, Electrical Stimulation

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
HiTop
Sponsored by
Vienna Hospital Association
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemotherapy-induced Peripheral Neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Klinik Donaustadt

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

HiTop

Sham stimulation

Arm Description

Outcomes

Primary Outcome Measures

Intensity of paresthesia
NRS scale

Secondary Outcome Measures

health related Quality of life (QOL), detailed symptroms of neuropathy
EORTC C30, CIPN 20, Neuropathy symptom scale (NSS), NRS scales

Full Information

First Posted
March 2, 2020
Last Updated
October 8, 2023
Sponsor
Vienna Hospital Association
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1. Study Identification

Unique Protocol Identification Number
NCT06048471
Brief Title
High Tone Therapy for Chemotherapy Induced Neuropathy
Official Title
High Tone Therapy for Chemotherapy Induced Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
September 22, 2023 (Actual)
Study Completion Date
September 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vienna Hospital Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Peripheral Neuropathy, Electrical Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HiTop
Arm Type
Experimental
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
HiTop
Intervention Description
High tone transcutaneous electrical stimulation
Primary Outcome Measure Information:
Title
Intensity of paresthesia
Description
NRS scale
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
health related Quality of life (QOL), detailed symptroms of neuropathy
Description
EORTC C30, CIPN 20, Neuropathy symptom scale (NSS), NRS scales
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Klinik Donaustadt
City
Vienna
ZIP/Postal Code
1220
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No

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High Tone Therapy for Chemotherapy Induced Neuropathy

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