Auricular Acupressure : Improves Oxaliplatin-induced Peripheral Neuropathy

NCT04751513 | Unknown

• 1 other identifier: 202001339B0
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxaliplatin-induced Peripheral Neuropathy; Chemotherapy

Keywords

colorectal cancer; chemotherapy; Oxaliplatin-induced peripheral neuropathy; auricular acupressure; pain; quality of life

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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 Outcomes (1)

• European Organization for Research and Treatment of Cancer-Quality of life Questionnaire-Core 30 version 3.0 (EORTC QLO-C30).

  This assessment tool is used at baseline, change from baseline after 8 weeks, 10 weeks, and one month followed by completing the chemotherapy course.

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group will receive acupressure on six auricular points.

Other: auricular acupressure

Control group

NO INTERVENTION

The control group will receive no intervention.

Interventions

auricular acupressure OTHER

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

Experimental group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taipei, 10507, Taiwan

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Pain

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

TSUI-JU CHANG

CONTACT

+886935308271; ninachang1203@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 12, 2021
• Study Start: August 21, 2020
• Primary Completion: August 20, 2021
• Study Completion: August 20, 2021
• Last Updated: February 12, 2021

Record last verified: 2021-01

Locations

TW (1)