The Effect of Acupuncture in Chemotherapy-induced Nausea and Vomiting

Chemotherapy-induced Nausea and Vomiting Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02369107
• Other study ID #: XM201410
• Status: Not yet recruiting
• Phase: N/A
• First received: February 15, 2015
• Last updated: February 17, 2015
• Start date: February 2015
• Est. completion date: December 2016

Study information

• Verified date: February 2015
• Source: Beijing Hospital of Traditional Chinese Medicine
• Contact: Xiaomin Wang, Doctor
• Phone: +86(010)52176508
• Email: wangxiaomin_bhtcm[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical 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 chemotherapy-induced nausea and vomiting on patients with malignancy

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 136
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chemotherapy-induced Nausea and Vomiting
• Nausea
• Vomiting

Intervention

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 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).

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Beijing Hospital of Traditional Chinese Medicine	Beijing Friendship Hospital, Beijing Municipal Administration of Hospitals, Beijing Shijitan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	No
Secondary	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.	Yes
Secondary	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.	No