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Trial record 1 of 1 for:    NCT02369107
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The Effect of Acupuncture in Chemotherapy-induced Nausea and Vomiting

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ClinicalTrials.gov Identifier: NCT02369107
Recruitment Status : Unknown
Verified February 2015 by Wang Xiaomin, Beijing Hospital of Traditional Chinese Medicine.
Recruitment status was:  Not yet recruiting
First Posted : February 23, 2015
Last Update Posted : February 23, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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 chemotherapy-induced nausea and vomiting on patients with malignancy

Condition or disease Intervention/treatment
Chemotherapy-induced Nausea and Vomiting Other: Verum acupuncture and medicine Other: Sham acupuncture and medicine

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Verum acupuncture and medicine
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).
Other: Verum acupuncture and medicine
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 Comparator: Sham acupuncture and medicine
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).
Other: Sham acupuncture and medicine
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).


Outcome Measures

Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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. ]
    to evaluate TCM syndrome

  2. 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. ]
    to evaluate physical condition of patients

  3. HADS [ Time Frame: It will be assessed at baseline, day3, day7(±1), day14(±1), day21(±1).Patients will be accessed with questionaire by doctors. ]
    a questionnaire to access the anxiety levels of patients


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Aged 18-75.
  3. Patients will receive chemotherapy treatment which included Cisplatin, anthracycline or taxane during the study period.
  4. ECOG score is between 0 and 2.
  5. The patients are diagnosed with insufficiency of spleen-qi and stomach-qi,reverse ascending of Stomach-Qi in traditional Chinese medicine theory.
  6. The expected lifetime of the patient is longer than 6 months.
  7. Patients willing to participate in the study and sign the consent form.

Exclusion Criteria:

  1. Patients have serious disease in cardiovascular system ,liver system,kidney system, immune systems and hemopoietic system.
  2. Pregnant and lactating women.
  3. 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.
  4. Patients with Coagulopathy, thrombocytopenia, or suffering from bleeding disorders.
  5. Patients have been definitely diagnosed with depression, anxiety disorders and psychosis
  6. Patients with Sepsis or Bacteremia.
  7. Patients have lymphedema in acupuncture stimulation area.
  8. Patients who are afraid of acupuncture stimulation or allergic to stainless steel needles can't participate in this study.
Contacts and Locations

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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): NCT02369107


Contacts
Contact: Xiaomin Wang, Doctor +86(010)52176508 wangxiaomin_bhtcm@126.com

Sponsors and Collaborators
Beijing Hospital of Traditional Chinese Medicine
Beijing Shijitan Hospital
Beijing Friendship Hospital
Beijing Municipal Administration of Hospitals
Investigators
Principal Investigator: Xiaomin Wang, Doctor Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
More Information

Responsible Party: Wang Xiaomin, Doctor, Beijing Hospital of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02369107     History of Changes
Other Study ID Numbers: XM201410
First Posted: February 23, 2015    Key Record Dates
Last Update Posted: February 23, 2015
Last Verified: February 2015

Keywords provided by Wang Xiaomin, Beijing Hospital of Traditional Chinese Medicine:
acupuncture
chemotherapy-induced nausea and vomiting

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents