Peripheral NeuropathyNCT01892852
Acupuncture for Chemotherapy-induced Peripheral Neuropathy
A study testing Acupuncture in people with Peripheral Neuropathy and Toxicity Due to Chemotherapy, run by Pusan National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate whether acupuncture can be effective for chemotherapy-induced peripheral neuropathy in lymphoma or multiple myeloma patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Neuropathy, Toxicity Due to Chemotherapy, Lymphoma
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2013to Apr 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age and have diagnosis of a lymphoma or multiple myeloma.
- Patients must have chemotherapy-induced peripheral neuropathy greater or equal to 2 according to CTCAE (Common Terminology Criteria for Adverse Events) v 3.0 scale (Appendix A) in spite of previous conventional medications, e.g. Neurontin, Cymbalta and/or Lyrica. Patients receiving any of conventional medication for this symptoms must remain on the same medications throughout the study period.
- Patients, or the legal guardians of patients, must have the ability to understand Korean, and be ble to provide informed consent.
- ECOG (Eastern Cooperative Oncology Group) Performance Status of 0, 1, or 2.
- If the patient is a woman of child-bearing potential, she must have a negative urine pregnancy test and agree to use contraception.
Who cannot join
- Other diseases that, in the opinion of the investigators, can cause peripheral neuropathy, such as alcoholism, diabetes mellitus, and HIV.
- Current active treatment for lymphoma or multiple myeloma
- Ongoing local infection at or near the acupuncture point adopted in this trial.
- Severe immunocompromised patients, leukopenia ( < 4,000/㎣) or neutropenia ( < 1,500/㎣)
- Known coagulopathy, thrombocytopenia (< 50,000/㎣), and taking heparin (including low molecular weight heparin) or Coumadin at any dose.
- Serious emotional or mental problems that precludes study entry.
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- Mental and physical disability that precludes accurate acupuncture.
- Serious systemic diseases such as active infection, severe heart disease, uncontrolled hypertension and diabetes mellitus.
- Cardiac pacemaker.
- Pregnant or breastfeeding
- Acupuncture therapy within the previous 30 days
- Concurrent other complementary and alternative therapy such as herbal agents, high dose vitamins, and etc.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Hematology-Oncology and Center for Integrative Medicine, Pusan National University Hospital
Busan, 602-739
Chang Woo Han, PhD, +82-51-240-6835, yeast10@hanmail.net
Ho-Jin Shin, MD, PhD
About this study
Official title: Acupuncture Therapy for Chemotherapy-induced Peripheral Neuropathy in Lymphoma or Multiple Myeloma Patients: a Pilot Study
The purpose of this study is to evaluate whether acupuncture can be effective for chemotherapy-induced peripheral neuropathy in lymphoma or multiple myeloma patients.
- Being tested
- Acupuncture
- Keywords
- Acupuncture, Traditional Korean Medicine
- Medical subject headings
- Peripheral Nervous System Diseases, Lymphoma, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Acupuncture treatment will be performed by licensed doctors in Traditional Korean Medicine using 0.20 mm (diameter) X 0.40 mm (length) sized disposable acupuncture 3 times per week for 3 weeks. Acupuncture points are GV20, GB20 (bilateral), LI11 (bilateral), LI10 (bilateral), EX-UE9 (bilateral), ST36 (bilateral), ST40 (bilateral), and EX-LE10 (bilateral). Each session lasts 20-30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Acupuncture treatment Receives: Procedure: Acupuncture |
| Control | No intervention | No other active treatment or sham acupuncture for this symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of NCIC-CTC (National Cancer Institute of Canada - Common Toxicity Criteria) 4.0 scale from baseline
Measured: At baseline, 1, 2, 3, and 7 wks from baseline
Secondary outcomes (3)
Change of VAS (Visual Analogue Scale) from baseline
Measured: At baseline, 1, 2, 3, and 7 wks from baseline
Change of FACT/GOG-Ntx (Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity) from baseline
Measured: At baseline, 1, 2, 3, and 7 wks from baseline
Adverse events
Measured: From study enrollment to the last follow-up (up to 7 wks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionApr 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ho-Jin Shin, PhD, Principal investigator, Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01892852
- Sponsor's protocol ID
- AcuCIPN
- Status last verified
- Jul 2013
- First submitted
- 18 Jun 2013
- Last updated
- 17 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Therapy for Chemotherapy-induced Peripheral Neuropathy in Lymphoma or Multiple Myeloma Patients: a Pilot Study
- ClinicalTrials.gov ID
- NCT01892852
- Acronym / sponsor ID
- AcuCIPN
- Keywords
- Acupuncture, Traditional Korean Medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 4 Jul 2013 (estimated)
- 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.
The purpose of this study is to evaluate whether acupuncture can be effective for chemotherapy-induced peripheral neuropathy in lymphoma or multiple myeloma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Procedure: AcupunctureAcupuncture treatment |
| Control | No intervention | –No other active treatment or sham acupuncture for this symptoms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years of age and have diagnosis of a lymphoma or multiple myeloma.
- Patients must have chemotherapy-induced peripheral neuropathy greater or equal to 2 according to CTCAE (Common Terminology Criteria for Adverse Events) v 3.0 scale (Appendix A) in spite of previous conventional medications, e.g. Neurontin, Cymbalta and/or Lyrica. Patients receiving any of conventional medication for this symptoms must remain on the same medications throughout the study period.
- Patients, or the legal guardians of patients, must have the ability to understand Korean, and be ble to provide informed consent.
- ECOG (Eastern Cooperative Oncology Group) Performance Status of 0, 1, or 2.
- If the patient is a woman of child-bearing potential, she must have a negative urine pregnancy test and agree to use contraception.
Key exclusion criteria (12 listed)
- Other diseases that, in the opinion of the investigators, can cause peripheral neuropathy, such as alcoholism, diabetes mellitus, and HIV.
- Current active treatment for lymphoma or multiple myeloma
- Ongoing local infection at or near the acupuncture point adopted in this trial.
- Severe immunocompromised patients, leukopenia ( < 4,000/㎣) or neutropenia ( < 1,500/㎣)
- Known coagulopathy, thrombocytopenia (< 50,000/㎣), and taking heparin (including low molecular weight heparin) or Coumadin at any dose.
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 |
|---|---|---|
| AcupunctureAcupuncture treatment will be performed by licensed doctors in Traditional Korean Medicine using 0.20 mm (diameter) X 0.40 mm (length) sized disposable acupuncture 3 times per week for 3 weeks. Acupuncture points are GV20, GB20 (bilateral), LI11 (bilateral), LI10 (bilateral), EX-UE9 (bilateral), ST36 (bilateral), ST40 (bilateral), and EX-LE10 (bilateral). Each session lasts 20-30 minutes. | Procedure or surgery | Acupuncture |
Primary outcome
Change of NCIC-CTC (National Cancer Institute of Canada - Common Toxicity Criteria) 4.0 scale from baseline
Time frame: At baseline, 1, 2, 3, and 7 wks from baseline
3 secondary outcomes
Change of VAS (Visual Analogue Scale) from baseline
Time frame: At baseline, 1, 2, 3, and 7 wks from baseline
Change of FACT/GOG-Ntx (Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity) from baseline
Time frame: At baseline, 1, 2, 3, and 7 wks from baseline
Adverse events
Time frame: From study enrollment to the last follow-up (up to 7 wks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2013.
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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.
Ho-Jin Shin, PhD principal investigator
Pusan National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Peripheral Neuropathy and Toxicity Due to Chemotherapy, run by Pusan National University Hospital at 1 site in South Korea.
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 5 inclusion and 12 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 17 Jul 2013. 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 South Korea. 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 Chang Woo Han, PhD (+82-51-240-6835, yeast10@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of NCIC-CTC (National Cancer Institute of Canada - Common Toxicity Criteria) 4.0 scale from baseline (time frame: At baseline, 1, 2, 3, and 7 wks from baseline). 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 17 Jul 2013.