NeurotoxicityNCT03330964
Clinical Trial of Electroacupuncture Stimulation on Prevention and Treatment of Oxaliplatin Neurotoxicity
A study testing electro-acupuncture in people with Neurotoxicity and Gastrointestinal Neoplasms, run by The First Affiliated Hospital of Dalian Medical University at 2 sites in China.
Trial summary
The clinical trail of electroacupuncture combined with oxaliplatin regimen on gastrointestinal carcinoma.This trail is randomized controled.Patients are diagnosed gastrointestinal cancer based on pathology or cell biology.They are randomized into 2 groups:both groups receive Oxaliplatin regimen.The treatment group… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neurotoxicity, Gastrointestinal Neoplasms
- What is being tested?
- electro-acupuncture
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesChina
- Study dates
- 1 Sep 2017to May 2018
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age:18-80 ;
- male and female ;
- signed the informed consent form;
- Eastern Cooperative oncology Group(ECOG)O-2,life expectancy more than 3 months;
- Indication for Chemotherapy,no contraindication;
- First time chemotherapy or at least 6 months after last chemotherapy and radiotherapy;
- At least 8 weeks after last biotherapy;
- Surgery:had not received transplantation surgery,at least 2 weeks after last major surgery.
Who cannot join
- Chemotherapy is contraindicated;
- Having the primary disease can cause the neuropathy;
- A history of other malignant tumor in recent 5 years;
- Less than 6 months after last chemotherapy or radiotherapy;
- Less than 8 weeks after last biotherapy;
- Being afraid of acupuncture seriously;
- Had received transplantation surgery,less than 2 weeks after last major surgery;
- Other researchers think is not suitable for this clinical trail.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Oncology Department，The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011
Xiaonan Cui, MD,PhD, +8618098876725, cxn23@sina.com
Weiwei Zhang, MM, +8613234062398, 1650579799@qq.com
- Not yet recruiting
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011
Xiaonan Cu, MD,PhD, +8618098876725, cxn23@sina.com
Weiwei Zhang, MM, +8613234062398, 1650579799@qq.com
About this study
Official title: Parallel Control Study of Electroacupuncture Stimulation the Acupoints of Yangming Channel on Prevention and Treatment of Oxaliplatin Neurotoxicity During the Peri-chemotherapy Period
The clinical trail of electroacupuncture combined with oxaliplatin regimen on gastrointestinal carcinoma.This trail is randomized controled.Patients are diagnosed gastrointestinal cancer based on pathology or cell biology.They are randomized into 2 groups:both groups receive Oxaliplatin regimen.The treatment group receives electroacupuncture in addition to the chemotherapy.The control group only receive the same chemotherapy with the treatment group.Both group have the same adjuvant therapy.
Read the detailed description
The clinical trail of electroacupuncture combined with oxaliplatin regimen on gastrointestinal carcinoma.This trail is randomized controled.Patients are diagnosed gastrointestinal cancer based on pathology or cell biology.They are randomized into 2 groups:both groups receive Oxaliplatin regimen.The treatment group receives electroacupuncture in addition to the chemotherapy.The control group only receive the same chemotherapy with the treatment group.Both group have the same adjuvant therapy.Mainly to study about oxaliplatin into electroacupuncture leads to the influence of the peripheral nerve toxicity.Other clinical evaluation includes chemotherapy drug toxicities,quality of life(QOL), etc.
- Conditions
- Neurotoxicity, Gastrointestinal Neoplasms
- Being tested
- electro-acupuncture
- Medical subject headings
- Neurotoxicity Syndromes, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electro-acupunctureOther
Electroacupuncture was administrated immediately after completion of oxaliplatin infusion,once a day for 3 days,30 minutes each time.
| Study group | Role | What they receive |
|---|---|---|
| electroacupuncture group | Experimental | The experimental group adopted chemotherapy combined with electro-acupuncture stimulated related acupoints for 3 days running. Receives: Other: electro-acupuncture |
| control group | No intervention | The control group received chemotherapy only(same as the experimental group),but no electroacupuncture treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levi sensory nerve toxicity classification standard
Scoring scale
Measured: every cycle of chemotherapy (measure 3 cycles, each cycle is 21 days), up to 3 months]
Secondary outcomes (1)
The quality of life questionnaire(QLQ)-C30
Scoring scale
Measured: every cycle of chemotherapy (measure 3 cycles, each cycle is 21 days), up to 3 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 Sep 2017
- Primary completionMar 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurotoxicityStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaonan Cui, MD,PhD, Principal investigator, The First Affiliated Hospital of Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330964
- Sponsor's protocol ID
- YJ-KY-2017-102
- Status last verified
- Sep 2017
- First submitted
- 27 Sep 2017
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parallel Control Study of Electroacupuncture Stimulation the Acupoints of Yangming Channel on Prevention and Treatment of Oxaliplatin Neurotoxicity During the Peri-chemotherapy Period
- ClinicalTrials.gov ID
- NCT03330964
- Acronym / sponsor ID
- YJ-KY-2017-102
- Conditions
- Neurotoxicity, Gastrointestinal Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 6 Nov 2017 (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.
The clinical trail of electroacupuncture combined with oxaliplatin regimen on gastrointestinal carcinoma.This trail is randomized controled.Patients are diagnosed gastrointestinal cancer based on pathology or cell biology.They are randomized into 2 groups:both groups receive Oxaliplatin regimen.The treatment group receives electroacupuncture in addition to the chemotherapy.The control group only receive the same chemotherapy with the treatment group.Both group have the same adjuvant therapy.
Detailed description
The clinical trail of electroacupuncture combined with oxaliplatin regimen on gastrointestinal carcinoma.This trail is randomized controled.Patients are diagnosed gastrointestinal cancer based on pathology or cell biology.They are randomized into 2 groups:both groups receive Oxaliplatin regimen.The treatment group receives electroacupuncture in addition to the chemotherapy.The control group only receive the same chemotherapy with the treatment group.Both group have the same adjuvant therapy.Mainly to study about oxaliplatin into electroacupuncture leads to the influence of the peripheral nerve toxicity.Other clinical evaluation includes chemotherapy drug toxicities,quality of life(QOL), etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| electroacupuncture group | Experimental | Other: electro-acupunctureThe experimental group adopted chemotherapy combined with electro-acupuncture stimulated related acupoints for 3 days running. |
| control group | No intervention | –The control group received chemotherapy only(same as the experimental group),but no electroacupuncture treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age:18-80 ;
- male and female ;
- signed the informed consent form;
- Eastern Cooperative oncology Group(ECOG)O-2,life expectancy more than 3 months;
- Indication for Chemotherapy,no contraindication;
Key exclusion criteria (8 listed)
- Chemotherapy is contraindicated;
- Having the primary disease can cause the neuropathy;
- A history of other malignant tumor in recent 5 years;
- Less than 6 months after last chemotherapy or radiotherapy;
- Less than 8 weeks after last biotherapy;
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 |
|---|---|---|
| electro-acupunctureElectroacupuncture was administrated immediately after completion of oxaliplatin infusion,once a day for 3 days,30 minutes each time. | Other | electroacupuncture group |
Primary outcome
Levi sensory nerve toxicity classification standard
Time frame: every cycle of chemotherapy (measure 3 cycles, each cycle is 21 days), up to 3 months]
Scoring scale
1 secondary outcome
The quality of life questionnaire(QLQ)-C30
Time frame: every cycle of chemotherapy (measure 3 cycles, each cycle is 21 days), up to 3 months]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Individual participant dataSharing planned: Undecided. Undecided
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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.
Xiaonan Cui, MD,PhD principal investigator
The First Affiliated Hospital of Dalian Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electro-acupuncture in people with Neurotoxicity and Gastrointestinal Neoplasms, run by The First Affiliated Hospital of Dalian Medical University at 2 sites in China.
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 8 inclusion and 8 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 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 Xiaonan Cui, MD,PhD (+8618098876725, cxn23@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levi sensory nerve toxicity classification standard (time frame: every cycle of chemotherapy (measure 3 cycles, each cycle is 21 days), up to 3 months]). 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 6 Nov 2017; AzTrials last refreshed its copy on 8 Nov 2026.