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Auricular Acupressure : Improves Oxaliplatin-induced Peripheral Neuropathy

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ClinicalTrials.gov Identifier: NCT04751513
Recruitment Status : Recruiting
First Posted : February 12, 2021
Last Update Posted : February 12, 2021
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Oxaliplatin-induced Peripheral Neuropathy Chemotherapy Other: auricular acupressure Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Auricular Acupressure Improves Oxaliplatin-induced Peripheral Neuropathy and Quality of Life
Actual Study Start Date : August 21, 2020
Estimated Primary Completion Date : August 20, 2021
Estimated Study Completion Date : August 20, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental group
The experimental group will receive acupressure on six auricular points.
Other: auricular acupressure
Pressure on auricular point of Shenmen (TF4), Sympathesis (AH6a), Subcortex (AT4), Endocrine (CO18), finger (SF1), and toe (AH2) of the ear.

No Intervention: Control group
The control group will receive no intervention.



Primary Outcome Measures :
  1. National Cancer Institute Common Terminology Criteria for Adverse Events v5.0[NCI-CTCAE v5.0] [ 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. ]
    For the severity of peripheral neuropathy symptoms caused by Oxaliplatin chemotherapy.

  2. Chemotherapy-induced Peripheral Neuropathy Assessment Tool(CIPNAT) [ 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. ]
    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.

  3. Neuropathic Pain Symptom inventory (NPSI) [ 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. ]
    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

  4. Visual Analogue Scale (VAS) [ 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. ]
    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 :
  1. European Organization for Research and Treatment of Cancer-Quality of life Questionnaire-Core 30 version 3.0 (EORTC QLO-C30). [ 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. ]
    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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04751513


Contacts
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Contact: TSUI-JU CHANG +886935308271 ninachang1203@gmail.com

Locations
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Taiwan
Chang Gung Memorial Hospital Recruiting
Taipei, Taiwan, 10507
Contact: TSUI-JU CHANG    011886935308271    ninachang1203@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT04751513    
Other Study ID Numbers: 202001339B0
First Posted: February 12, 2021    Key Record Dates
Last Update Posted: February 12, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chang Gung Memorial Hospital:
colorectal cancer
chemotherapy
Oxaliplatin-induced peripheral neuropathy
auricular acupressure
pain
quality of life
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases