Oxaliplatin-induced Peripheral NeuropathyNCT04751513
Auricular Acupressure : Improves Oxaliplatin-induced Peripheral Neuropathy
A study testing auricular acupressure in people with Oxaliplatin-induced Peripheral Neuropathy and Chemotherapy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Oxaliplatin-induced Peripheral Neuropathy, Chemotherapy
- What is being tested?
- auricular acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Aug 2020to 20 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taipei, 10507
TSUI-JU CHANG, 011886935308271, ninachang1203@gmail.com
About this study
Official title: Auricular Acupressure Improves Oxaliplatin-induced Peripheral Neuropathy and Quality of Life
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.
Read the 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.
- Being tested
- auricular acupressure
- Keywords
- colorectal cancer, chemotherapy, Oxaliplatin-induced peripheral neuropathy, auricular acupressure, pain, quality of life
- Medical subject headings
- Colorectal Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
auricular acupressureOther
Pressure on auricular point of Shenmen (TF4), Sympathesis (AH6a), Subcortex (AT4), Endocrine (CO18), finger (SF1), and toe (AH2) of the ear.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The experimental group will receive acupressure on six auricular points. Receives: Other: auricular acupressure |
| Control group | No intervention | The control group will receive no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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).
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.
Measured: This assessment tool is used at baseline, change from baseline after 8 weeks, 10 weeks, and one month followed by completing the chemotherapy course.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start21 Aug 2020
- Primary completion20 Aug 2021 (estimated)
- Study completion20 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxaliplatin-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751513
- Sponsor's protocol ID
- 202001339B0
- Status last verified
- Jan 2021
- First submitted
- 25 Jan 2021
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Acupressure Improves Oxaliplatin-induced Peripheral Neuropathy and Quality of Life
- ClinicalTrials.gov ID
- NCT04751513
- Acronym / sponsor ID
- 202001339B0
- Keywords
- colorectal cancer, chemotherapy, Oxaliplatin-induced peripheral neuropathy, auricular acupressure, pain, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 21 Aug 2020 (actual)
- Primary completion
- 20 Aug 2021 (estimated)
- Study completion
- 20 Aug 2021 (estimated)
- First posted
- 12 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: auricular acupressureThe experimental group will receive acupressure on six auricular points. |
| Control group | No intervention | –The control group will receive no intervention. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| auricular acupressurePressure on auricular point of Shenmen (TF4), Sympathesis (AH6a), Subcortex (AT4), Endocrine (CO18), finger (SF1), and toe (AH2) of the ear. | Other | Experimental group |
Primary outcome
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.
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.
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
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.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
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Acupuncture for Oxaliplatin-induced Peripheral Neuropathy in Gastro-intestinal Cancer Patients
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Prevention of Oxaliplatin-induced Nerve Damage in the Body's Extremities
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing auricular acupressure in people with Oxaliplatin-induced Peripheral Neuropathy and Chemotherapy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact TSUI-JU CHANG (+886935308271, ninachang1203@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2021.