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The Effect of Acupuncture in Chemotherapy-induced Nausea and Vomiting

Primary Purpose

Chemotherapy-induced Nausea and Vomiting

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Verum acupuncture and medicine
Sham acupuncture and medicine
Sponsored by
Beijing Hospital of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemotherapy-induced Nausea and Vomiting focused on measuring acupuncture, chemotherapy-induced nausea and vomiting

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Verum acupuncture and medicine

    Sham acupuncture and medicine

    Arm Description

    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).

    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).

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    TCM symptoms scale
    to evaluate TCM syndrome
    ECOG score scale
    to evaluate physical condition of patients
    HADS
    a questionnaire to access the anxiety levels of patients

    Full Information

    First Posted
    February 15, 2015
    Last Updated
    February 17, 2015
    Sponsor
    Beijing Hospital of Traditional Chinese Medicine
    Collaborators
    Beijing Shijitan Hospital, Capital Medical University, Beijing Friendship Hospital, Beijing Municipal Administration of Hospitals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02369107
    Brief Title
    The Effect of Acupuncture in Chemotherapy-induced Nausea and Vomiting
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2015 (undefined)
    Primary Completion Date
    December 2015 (Anticipated)
    Study Completion Date
    December 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Beijing Hospital of Traditional Chinese Medicine
    Collaborators
    Beijing Shijitan Hospital, Capital Medical University, Beijing Friendship Hospital, Beijing Municipal Administration of Hospitals

    4. Oversight

    Data Monitoring Committee
    No

    5. 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chemotherapy-induced Nausea and Vomiting
    Keywords
    acupuncture, chemotherapy-induced nausea and vomiting

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    136 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Verum acupuncture and medicine
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Sham acupuncture and medicine
    Arm Type
    Sham Comparator
    Arm Description
    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).
    Intervention Type
    Other
    Intervention Name(s)
    Verum acupuncture and medicine
    Intervention Description
    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).
    Intervention Type
    Other
    Intervention Name(s)
    Sham acupuncture and medicine
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Change from Baseline in severity of nausea and vomiting at 21 days
    Description
    The severity of nausea and vomiting will be assessed by the Common Terminology Criteria for Adverse Events (CTCAE)
    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
    Secondary Outcome Measure Information:
    Title
    TCM symptoms scale
    Description
    to evaluate TCM syndrome
    Time Frame
    It will be assessed at baseline, day3, day7(±1), day14(±1), day21(±1).Patients will be accessed with questionaire by doctors.
    Title
    ECOG score scale
    Description
    to evaluate physical condition of patients
    Time Frame
    It will be assessed at baseline, day3, day7(±1), day14(±1), day21(±1).Patients will be accessed with questionaire by doctors.
    Title
    HADS
    Description
    a questionnaire to access the anxiety levels of patients
    Time Frame
    It will be assessed at baseline, day3, day7(±1), day14(±1), day21(±1).Patients will be accessed with questionaire by doctors.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xiaomin Wang, Doctor
    Phone
    +86(010)52176508
    Email
    wangxiaomin_bhtcm@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xiaomin Wang, Doctor
    Organizational Affiliation
    Beijing Hospital of Traditional Chinese Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28427442
    Citation
    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.
    Results Reference
    derived

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    The Effect of Acupuncture in Chemotherapy-induced Nausea and Vomiting

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