Clinical trial NCT04751513: Auricular Acupressure : Improves Oxaliplatin-induced Peripheral Neuropathy
Official title: Auricular Acupressure Improves Oxaliplatin-induced Peripheral Neuropathy and Quality of Life
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oxaliplatin-induced Peripheral Neuropathy
Chemotherapy
Keywords: colorectal cancer
chemotherapy
Oxaliplatin-induced peripheral neuropathy
auricular acupressure
pain
quality of life
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 76
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: National Cancer Institute Common Terminology Criteria for Adverse Events v5.0[NCI-CTCAE v5.0]
timeFrame: 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.
measure: Chemotherapy-induced Peripheral Neuropathy Assessment Tool(CIPNAT)
timeFrame: 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.
measure: Neuropathic Pain Symptom inventory (NPSI)
timeFrame: 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.
measure: Visual Analogue Scale (VAS)
timeFrame: 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 outcomes:
measure: European Organization for Research and Treatment of Cancer-Quality of life Questionnaire-Core 30 version 3.0 (EORTC QLO-C30).
timeFrame: This assessment tool is used at baseline, change from baseline after 8 weeks, 10 weeks, and one month followed by completing the chemotherapy course.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
References: