The Effect of Acupuncture in Chemotherapy-induced Nausea and Vomiting

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

Study Overview

• Status: Unknown
• Conditions: Chemotherapy-induced Nausea and Vomiting
• Intervention / Treatment: Other: Verum acupuncture and medicine; Other: Sham acupuncture and medicine

• Study Type: Interventional
• Enrollment (Anticipated): 136
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
TCM symptoms scale	to evaluate TCM syndrome	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	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	It will be assessed at baseline, day3, day7(±1), day14(±1), day21(±1).Patients will be accessed with questionaire by doctors.

Collaborators and Investigators

• Sponsor: Beijing Hospital of Traditional Chinese Medicine
• Collaborators: Beijing Friendship Hospital; Beijing Shijitan Hospital, Capital Medical University; Beijing Municipal Administration of Hospitals
• Investigators: Principal Investigator: Xiaomin Wang, Doctor, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: February 15, 2015
• First Submitted That Met QC Criteria: February 17, 2015
• First Posted (Estimate): February 23, 2015

Study Record Updates

• Last Update Posted (Estimate): February 23, 2015
• Last Update Submitted That Met QC Criteria: February 17, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: acupuncture; chemotherapy-induced nausea and vomiting
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting
• Other Study ID Numbers: XM201410