Auricular Acupressure : Improves Oxaliplatin-induced Peripheral Neuropathy

NCT ID: NCT04751513

Last Updated: 2021-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-21

Study Completion Date

2021-08-20

Brief Summary

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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

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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.

Conditions

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Oxaliplatin-induced Peripheral Neuropathy Chemotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental group

The experimental group will receive acupressure on six auricular points.

Group Type EXPERIMENTAL

auricular acupressure

Intervention Type OTHER

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

Control group

The control group will receive no intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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auricular acupressure

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chang Gung Memorial Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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TSUI-JU CHANG

Role: CONTACT

+886935308271

Facility Contacts

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TSUI-JU CHANG

Role: primary

011886935308271

Other Identifiers

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202001339B0

Identifier Type: -

Identifier Source: org_study_id

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