Auricular Acupressure : Improves Oxaliplatin-induced Peripheral Neuropathy
Primary Purpose
Oxaliplatin-induced Peripheral Neuropathy, Chemotherapy
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
auricular acupressure
Sponsored by
About this trial
This is an interventional treatment trial for Oxaliplatin-induced Peripheral Neuropathy focused on measuring colorectal cancer, chemotherapy, Oxaliplatin-induced peripheral neuropathy, auricular acupressure, pain, quality of life
Eligibility Criteria
Inclusion Criteria:
- Colorectal cancer patients who are above the age of 20 years
- Have experiencing Oxaliplatin induced peripheral neuropathy
- Must be able to communicate
- Willing to fill out the inform consent
Exclusion Criteria:
- Symptoms of peripheral neuropathy caused by diabetes mellitus
- Symptoms of peripheral neuropathy caused by genetic disease
- Symptoms of peripheral neuropathy caused by spinal cord injury
- Symptoms of peripheral neuropathy caused by alcoholism
- With wounds on ears
- Allergy to latex (the tapes for the auricular acupressure include latex)
Sites / Locations
- Chang Gung Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental group
Control group
Arm Description
The experimental group will receive acupressure on six auricular points.
The control group will receive no intervention.
Outcomes
Primary Outcome Measures
National Cancer Institute Common Terminology Criteria for Adverse Events v5.0[NCI-CTCAE v5.0]
For the severity of peripheral neuropathy symptoms caused by Oxaliplatin chemotherapy.
Chemotherapy-induced Peripheral Neuropathy Assessment Tool(CIPNAT)
This questionnaire is a self-assessment of the patient. It is divided into four parts: 1. The severity of symptoms; 2. The degree of trouble the symptom causes; 3. The frequency of symptoms; 4. The symptom's degree of interference in daily life.
Neuropathic Pain Symptom inventory (NPSI)
This questionnaire mainly used to assess the symptoms and severity of neuropathic pain. This questionnaire consists of four parts: 1. spontaneous and persistent pain, 2. spontaneous paroxysmal pain, and 3. Induced pain and paresthesia
Visual Analogue Scale (VAS)
This study uses the Visual Analogue Scale (VAS) for pain. The patient will Self-assess the pain intensity based on their subjective feelings and current pain state.
Secondary Outcome Measures
European Organization for Research and Treatment of Cancer-Quality of life Questionnaire-Core 30 version 3.0 (EORTC QLO-C30).
The purpose of this questionnaire is to evaluate the impact of the overall quality of life of cancer patients after suffering from cancer or receiving treatment.
Full Information
NCT ID
NCT04751513
First Posted
January 25, 2021
Last Updated
February 8, 2021
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04751513
Brief Title
Auricular Acupressure : Improves Oxaliplatin-induced Peripheral Neuropathy
Official Title
Auricular Acupressure Improves Oxaliplatin-induced Peripheral Neuropathy and Quality of Life
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 21, 2020 (Actual)
Primary Completion Date
August 20, 2021 (Anticipated)
Study Completion Date
August 20, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
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
Oxaliplatin-induced peripheral neuropathy (OIPN) is a common adverse effect that becomes worse as the drug dose accumulation impacts cancer patients' daily activities and quality of life.The result of this study will determine the immediate effects of the 8-week auricular acupuncture intervention on alleviating the participants' OIPN symptoms and enhancing their quality of life. This study will continue to evaluate the carry-over effects of auricular acupuncture after the chemotherapy course ends.
Detailed Description
Objectives:
Oxaliplatin-induced peripheral neuropathy (OIPN) is a common adverse effect that becomes worse as the drug dose accumulation impacts cancer patients' daily activities and quality of life. This study aims to evaluate the immediate and carry-over effects of auricular acupressure on OIPN symptoms and quality of life for colorectal cancer patients.
Methods :
This randomized trial will recruit 76 participants with colorectal cancer and OIPN from the oncology outpatient department in Taiwan. The control group will receive usual care, whereas the experimental group will receive usual care in addition to auricular acupressure for 8 weeks. Outcomes will be assessed by using the chemotherapy-induced peripheral neuropathy assessment tool, neuropathic pain symptom inventory, pain visual analogue scale, and the European Organization for research and treatment of cancer-quality of life questionnaire-core 30. These assessment tools are used before the intervention, biweekly during the intervention, 2 weeks after the intervention, and one month after the end of the chemotherapy course.
Hypothesis:
Ultimately, the result of this study will determine the immediate effects of the 8-week auricular acupuncture intervention on alleviating the participants' OIPN symptoms and enhancing their quality of life. This study will continue to evaluate the carry-over effects of auricular acupuncture after the chemotherapy course ends.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxaliplatin-induced Peripheral Neuropathy, Chemotherapy
Keywords
colorectal cancer, chemotherapy, Oxaliplatin-induced peripheral neuropathy, auricular acupressure, pain, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study will conduct a randomized controlled trial by randomly assigning all participants to either the experimental group receiving auricular acupressure and usual care or the control group only receiving usual care. This study provides an auricular acupressure for eight weeks, and assesses the immediate and carry-over effects. These assessments happen biweekly during the intervention period, two weeks after the intervention period, as well as one month after the end of the chemotherapy course.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
The experimental group will receive acupressure on six auricular points.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will receive no intervention.
Intervention Type
Other
Intervention Name(s)
auricular acupressure
Intervention Description
Pressure on auricular point of Shenmen (TF4), Sympathesis (AH6a), Subcortex (AT4), Endocrine (CO18), finger (SF1), and toe (AH2) of the ear.
Primary Outcome Measure Information:
Title
National Cancer Institute Common Terminology Criteria for Adverse Events v5.0[NCI-CTCAE v5.0]
Description
For the severity of peripheral neuropathy symptoms caused by Oxaliplatin chemotherapy.
Time Frame
This assessment tool is used at baseline, change from baseline after 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, and one month followed by completing the chemotherapy course.
Title
Chemotherapy-induced Peripheral Neuropathy Assessment Tool(CIPNAT)
Description
This questionnaire is a self-assessment of the patient. It is divided into four parts: 1. The severity of symptoms; 2. The degree of trouble the symptom causes; 3. The frequency of symptoms; 4. The symptom's degree of interference in daily life.
Time Frame
This assessment tool is used at baseline, change from baseline after 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, and one month followed by completing the chemotherapy course.
Title
Neuropathic Pain Symptom inventory (NPSI)
Description
This questionnaire mainly used to assess the symptoms and severity of neuropathic pain. This questionnaire consists of four parts: 1. spontaneous and persistent pain, 2. spontaneous paroxysmal pain, and 3. Induced pain and paresthesia
Time Frame
This assessment tool is used at baseline, change from baseline after 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, and one month followed by completing the chemotherapy course.
Title
Visual Analogue Scale (VAS)
Description
This study uses the Visual Analogue Scale (VAS) for pain. The patient will Self-assess the pain intensity based on their subjective feelings and current pain state.
Time Frame
This assessment tool is used at baseline, change from baseline after 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, and one month followed by completing the chemotherapy course.
Secondary Outcome Measure Information:
Title
European Organization for Research and Treatment of Cancer-Quality of life Questionnaire-Core 30 version 3.0 (EORTC QLO-C30).
Description
The purpose of this questionnaire is to evaluate the impact of the overall quality of life of cancer patients after suffering from cancer or receiving treatment.
Time Frame
This assessment tool is used at baseline, change from baseline after 8 weeks, 10 weeks, and one month followed by completing the chemotherapy course.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Colorectal cancer patients who are above the age of 20 years
Have experiencing Oxaliplatin induced peripheral neuropathy
Must be able to communicate
Willing to fill out the inform consent
Exclusion Criteria:
Symptoms of peripheral neuropathy caused by diabetes mellitus
Symptoms of peripheral neuropathy caused by genetic disease
Symptoms of peripheral neuropathy caused by spinal cord injury
Symptoms of peripheral neuropathy caused by alcoholism
With wounds on ears
Allergy to latex (the tapes for the auricular acupressure include latex)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
TSUI-JU CHANG
Phone
+886935308271
Email
ninachang1203@gmail.com
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taipei
ZIP/Postal Code
10507
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TSUI-JU CHANG
Phone
011886935308271
Email
ninachang1203@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Auricular Acupressure : Improves Oxaliplatin-induced Peripheral Neuropathy
We'll reach out to this number within 24 hrs