Clinical trial NCT02369107: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Chemotherapy-induced Nausea and Vomiting
Keywords: acupuncture
chemotherapy-induced nausea and vomiting
Lead sponsor: Beijing Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Beijing Shijitan Hospital, Capital Medical University
name: Beijing Friendship Hospital
name: Beijing Municipal Administration of Hospitals
First posted: 2015-02-23
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Change from Baseline in severity of nausea and vomiting at 21 days
timeFrame: 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:
measure: TCM symptoms scale
timeFrame: It will be assessed at baseline, day3, day7(±1), day14(±1), day21(±1).Patients will be accessed with questionaire by doctors.
measure: ECOG score scale
timeFrame: It will be assessed at baseline, day3, day7(±1), day14(±1), day21(±1).Patients will be accessed with questionaire by doctors.
measure: HADS
timeFrame: It will be assessed at baseline, day3, day7(±1), day14(±1), day21(±1).Patients will be accessed with questionaire by doctors.
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Hospital of Traditional Chinese Medicine
name: Xiaomin Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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.