Chemotherapy-induced Nausea and VomitingNCT02369107
The Effect of Acupuncture in Chemotherapy-induced Nausea and Vomiting
A study testing Verum acupuncture and medicine in people with Chemotherapy-induced Nausea and Vomiting, run by Beijing Hospital of Traditional Chinese Medicine.
Trial summary
Nausea and vomiting are the most common symptoms experienced by cancer patients after chemotherapy. Some patients have to endure such unpleasant symptoms even after using of antiemetic or anti-vomiting medications.The purpose of this study is to assess the therapeutic effects and safety of acupuncture for… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chemotherapy-induced Nausea and Vomiting
- What is being tested?
- Verum acupuncture and medicine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Dec 2016
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with definite pathological diagnosis of lung cancer, breast cancer, and gynecological cancer.They haven't receive any chemotherapy or radiotherapy treatment for three months prior to join this study.
- Aged 18-75.
- Patients will receive chemotherapy treatment which included Cisplatin, anthracycline or taxane during the study period.
- ECOG score is between 0 and 2.
- The patients are diagnosed with insufficiency of spleen-qi and stomach-qi,reverse ascending of Stomach-Qi in traditional Chinese medicine theory.
- The expected lifetime of the patient is longer than 6 months.
- Patients willing to participate in the study and sign the consent form.
Who cannot join
- Patients have serious disease in cardiovascular system ,liver system,kidney system, immune systems and hemopoietic system.
- Pregnant and lactating women.
- Patients have intractable vomiting caused by malignant brain metastases, intracranial hypertention, digestive tract obstruction, severe liver or Renal dysfunction, brain tumors, cerebrovascular disease, or other reasons.
- Patients with Coagulopathy, thrombocytopenia, or suffering from bleeding disorders.
- Patients have been definitely diagnosed with depression, anxiety disorders and psychosis
- Patients with Sepsis or Bacteremia.
- Patients have lymphedema in acupuncture stimulation area.
- Patients who are afraid of acupuncture stimulation or allergic to stainless steel needles can't participate in this study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multi-center,Randomized Controlled Clinical Trial: the Effect of Acupuncture in Prevention and Treatment of Chemotherapy-induced Nausea and Vomiting on Patients With Malignancy
Nausea and vomiting are the most common symptoms experienced by cancer patients after chemotherapy. Some patients have to endure such unpleasant symptoms even after using of antiemetic or anti-vomiting medications.The purpose of this study is to assess the therapeutic effects and safety of acupuncture for chemotherapy-induced nausea and vomiting on patients with malignancy
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Being tested
- Verum acupuncture and medicine, Sham acupuncture and medicine
- Keywords
- acupuncture, chemotherapy-induced nausea and vomiting
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verum acupuncture and medicineOther
Participants will receive acupuncture therapy 1 hour prior to chemotherapy administration ，6 hours after chemotherapy administration，and once acupuncture therapy on the following day2,3,4,5. The stimulation points are RN12,LR13(bilaterally), RN6, ST25(bilaterally), PC6(bilaterally), ST36(bilaterally). The acupuncture needle in ST36 and auxiliary point will be connected to form a circuit containing a SDZ-V stimulator for 30 min with a frequency of 2/100 Hz. They will receive 8mg Ondansetron Intravenously twice a day during the chemotherapy administration period (5 days in total).
Sham acupuncture and medicineOther
Participants will receive minimal acupuncture therapy at the same time as the intervention group .The stimulation points are not belong to traditional Chinese medicine.They will receive 8mg Ondansetron Intravenously twice a day during the chemotherapy administration period (5 days in total).
| Study group | Role | What they receive |
|---|---|---|
| Verum acupuncture and medicine | Experimental | Participants will receive acupuncture therapy 1 hour prior to chemotherapy administration ，6 hours after chemotherapy administration，and once acupuncture therapy on the following day2,3,4,5. The stimulation points are RN12,LR13(bilaterally), RN6, ST25(bilaterally), PC6(bilaterally), ST36(bilaterally). The acupuncture needle in ST36 and auxiliary point will be connected to form a circuit containing a SDZ-V stimulator for 30 min with a frequency of 2/100 Hz.They will receive 8mg Ondansetron Intravenously twice a day during the chemotherapy administration period (5 days in total). Receives: Other: Verum acupuncture and medicine |
| Sham acupuncture and medicine | Sham comparator | Participants will receive minimal acupuncture therapy at the same time as the intervention group .The stimulation points are not belong to traditional Chinese medicine.They will receive 8mg Ondansetron Intravenously twice a day during the chemotherapy administration period (5 days in total). Receives: Other: Sham acupuncture and medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in severity of nausea and vomiting at 21 days
The severity of nausea and vomiting will be assessed by the Common Terminology Criteria for Adverse Events (CTCAE)
Measured: It will be assessed at baseline,day1, day 2, day 3, day 7(±1)，day 10(±1), day 14(±1), day 21(±1).Patients have a daily questionnaire about nausea and vomiting during chemotherapy to record their feelings
Secondary outcomes (3)
TCM symptoms scale
to evaluate TCM syndrome
Measured: It will be assessed at baseline, day3, day7(±1), day14(±1), day21(±1).Patients will be accessed with questionaire by doctors.
ECOG score scale
to evaluate physical condition of patients
Measured: It will be assessed at baseline, day3, day7(±1), day14(±1), day21(±1).Patients will be accessed with questionaire by doctors.
HADS
a questionnaire to access the anxiety levels of patients
Measured: It will be assessed at baseline, day3, day7(±1), day14(±1), day21(±1).Patients will be accessed with questionaire by doctors.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced Nausea and VomitingStudies 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
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Shijitan Hospital, Capital Medical University, Beijing Friendship Hospital, Beijing Municipal Administration of Hospitals
- Responsible party
- Principal investigator, Wang Xiaomin, Beijing Hospital of Traditional Chinese Medicine
- Investigators
- Xiaomin Wang, Doctor, Principal investigator, Beijing Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02369107
- Sponsor's protocol ID
- XM201410
- Status last verified
- Feb 2015
- First submitted
- 15 Feb 2015
- Last updated
- 23 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Li QW, Yu MW, Yang GW, Wang XM, Wang H, Zhang CX, Xue N, Xu WR, Fu Q, Yang Z, Yang L. Effect of acupuncture in prevention and treatment of chemotherapy-induced nausea and vomiting in patients with advanced cancer: study protocol for a randomized controlled trial. Trials. 2017 Apr 20;18(1):185. doi: 10.1186/s13063-017-1927-2.
PubMed 28427442
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center,Randomized Controlled Clinical Trial: the Effect of Acupuncture in Prevention and Treatment of Chemotherapy-induced Nausea and Vomiting on Patients With Malignancy
- ClinicalTrials.gov ID
- NCT02369107
- Acronym / sponsor ID
- XM201410
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Keywords
- acupuncture, chemotherapy-induced nausea and vomiting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Beijing Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Beijing Shijitan Hospital, Capital Medical University, Beijing Friendship Hospital, Beijing Municipal Administration of Hospitals
- Study start
- Feb 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 23 Feb 2015 (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.
Nausea and vomiting are the most common symptoms experienced by cancer patients after chemotherapy. Some patients have to endure such unpleasant symptoms even after using of antiemetic or anti-vomiting medications.The purpose of this study is to assess the therapeutic effects and safety of acupuncture for chemotherapy-induced nausea and vomiting on patients with malignancy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum acupuncture and medicine | Experimental | Other: Verum acupuncture and medicineParticipants will receive acupuncture therapy 1 hour prior to chemotherapy administration ，6 hours after chemotherapy administration，and once acupuncture therapy on the following day2,3,4,5. The stimulation points are RN12,LR13(bilaterally), RN6, ST25(bilaterally), PC6(bilaterally), ST36(bilaterally). The acupuncture needle in ST36 and auxiliary point will be connected to form a circuit containing a SDZ-V stimulator for 30 min with a frequency of 2/100 Hz.They will receive 8mg Ondansetron Intravenously twice a day during the chemotherapy administration period (5 days in total). |
| Sham acupuncture and medicine | Sham comparator | Other: Sham acupuncture and medicineParticipants will receive minimal acupuncture therapy at the same time as the intervention group .The stimulation points are not belong to traditional Chinese medicine.They will receive 8mg Ondansetron Intravenously twice a day during the chemotherapy administration period (5 days in total). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with definite pathological diagnosis of lung cancer, breast cancer, and gynecological cancer.They haven't receive any chemotherapy or radiotherapy treatment for three months prior to join this study.
- Aged 18-75.
- Patients will receive chemotherapy treatment which included Cisplatin, anthracycline or taxane during the study period.
- ECOG score is between 0 and 2.
- The patients are diagnosed with insufficiency of spleen-qi and stomach-qi,reverse ascending of Stomach-Qi in traditional Chinese medicine theory.
Key exclusion criteria (8 listed)
- Patients have serious disease in cardiovascular system ,liver system,kidney system, immune systems and hemopoietic system.
- Pregnant and lactating women.
- Patients have intractable vomiting caused by malignant brain metastases, intracranial hypertention, digestive tract obstruction, severe liver or Renal dysfunction, brain tumors, cerebrovascular disease, or other reasons.
- Patients with Coagulopathy, thrombocytopenia, or suffering from bleeding disorders.
- Patients have been definitely diagnosed with depression, anxiety disorders and psychosis
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 |
|---|---|---|
| Verum acupuncture and medicineParticipants will receive acupuncture therapy 1 hour prior to chemotherapy administration ，6 hours after chemotherapy administration，and once acupuncture therapy on the following day2,3,4,5. The stimulation points are RN12,LR13(bilaterally), RN6, ST25(bilaterally), PC6(bilaterally), ST36(bilaterally). The acupuncture needle in ST36 and auxiliary point will be connected to form a circuit containing a SDZ-V stimulator for 30 min with a frequency of 2/100 Hz. They will receive 8mg Ondansetron Intravenously twice a day during the chemotherapy administration period (5 days in total). | Other | Verum acupuncture and medicine |
| Sham acupuncture and medicineParticipants will receive minimal acupuncture therapy at the same time as the intervention group .The stimulation points are not belong to traditional Chinese medicine.They will receive 8mg Ondansetron Intravenously twice a day during the chemotherapy administration period (5 days in total). | Other | Sham acupuncture and medicine |
Primary outcome
Change from Baseline in severity of nausea and vomiting at 21 days
Time frame: It will be assessed at baseline,day1, day 2, day 3, day 7(±1)，day 10(±1), day 14(±1), day 21(±1).Patients have a daily questionnaire about nausea and vomiting during chemotherapy to record their feelings
The severity of nausea and vomiting will be assessed by the Common Terminology Criteria for Adverse Events (CTCAE)
3 secondary outcomes
TCM symptoms scale
Time frame: It will be assessed at baseline, day3, day7(±1), day14(±1), day21(±1).Patients will be accessed with questionaire by doctors.
ECOG score scale
Time frame: It will be assessed at baseline, day3, day7(±1), day14(±1), day21(±1).Patients will be accessed with questionaire by doctors.
HADS
Time frame: It will be assessed at baseline, day3, day7(±1), day14(±1), day21(±1).Patients will be accessed with questionaire by doctors.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2015.
- Derived from this study: PubMed 28427442Li QW, Yu MW, Yang GW, Wang XM, Wang H, Zhang CX, Xue N, Xu WR, Fu Q, Yang Z, Yang L. Effect of acupuncture in prevention and treatment of chemotherapy-induced nausea and vomiting in patients with advanced cancer: study protocol for a randomized controlled trial. Trials. 2017 Apr 20;18(1):185. doi: 10.1186/s13063-017-1927-2.
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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.
Xiaomin Wang, Doctor principal investigator
Beijing Hospital of Traditional Chinese Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Verum acupuncture and medicine in people with Chemotherapy-induced Nausea and Vomiting, run by Beijing Hospital of Traditional Chinese Medicine.
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 7 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 23 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Xiaomin Wang, Doctor (+86(010)52176508, wangxiaomin_bhtcm@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in severity of nausea and vomiting at 21 days (time frame: It will be assessed at baseline,day1, day 2, day 3, day 7(±1)，day 10(±1), day 14(±1), day 21(±1).Patients have a daily questionnaire about nausea and vomiting during chemotherapy to record their feelings). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02369107, which also lists 1 linked publication.
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 23 Feb 2015.