NCT02369107

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 23, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 23, 2015

Status Verified

February 1, 2015

Enrollment Period

10 months

First QC Date

February 15, 2015

Last Update Submit

February 17, 2015

Conditions

Chemotherapy-induced Nausea and Vomiting

Keywords

acupuncturechemotherapy-induced nausea and vomiting

Outcome Measures

Primary Outcomes (1)

  • 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)

    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

    It will be assessed at baseline, day3, day7(±1), day14(±1), day21(±1).Patients will be accessed with questionaire by doctors.

  • ECOG score scale

    It will be assessed at baseline, day3, day7(±1), day14(±1), day21(±1).Patients will be accessed with questionaire by doctors.

  • HADS

    It will be assessed at baseline, day3, day7(±1), day14(±1), day21(±1).Patients will be accessed with questionaire by doctors.

Study Arms (2)

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).

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).

Other: Sham acupuncture and medicine

Interventions

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).

Verum acupuncture and medicine
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).

Sham acupuncture and medicine

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 28427442DERIVED

MeSH Terms

Conditions

Vomiting

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsTechnology, PharmaceuticalInvestigative Techniques

Study Officials

  • Xiaomin Wang, Doctor

    Beijing Hospital of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaomin Wang, Doctor

CONTACT

+86(010)52176508wangxiaomin_bhtcm@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

February 15, 2015

First Posted

February 23, 2015

Study Start

February 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

February 23, 2015

Record last verified: 2015-02