Auricular Acupressure : Improves Oxaliplatin-induced Peripheral Neuropathy

Chemotherapy Clinical Trial

Official title:

Auricular Acupressure Improves Oxaliplatin-induced Peripheral Neuropathy and Quality of Life

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04751513
• Other study ID #: 202001339B0
• Status: Recruiting
• Phase: N/A
• Start date: August 21, 2020
• Est. completion date: August 20, 2021

Study information

• Verified date: January 2021
• Source: Chang Gung Memorial Hospital
• Contact: TSUI-JU CHANG
• Phone: +886935308271
• Email: ninachang1203[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: August 20, 2021
• Est. primary completion date: August 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chemotherapy
• Oxaliplatin-induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Other:
• auricular acupressure
Pressure on auricular point of Shenmen (TF4), Sympathesis (AH6a), Subcortex (AT4), Endocrine (CO18), finger (SF1), and toe (AH2) of the ear.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.
Primary	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.	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.
Primary	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	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.
Primary	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.	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	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.	This assessment tool is used at baseline, change from baseline after 8 weeks, 10 weeks, and one month followed by completing the chemotherapy course.