NCT02369107
Unknown
Not Applicable
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
Beijing Hospital of Traditional Chinese Medicine0 sites136 target enrollmentStarted: February 2015Last updated:
ConditionsChemotherapy-induced Nausea and Vomiting
Overview
- Phase
- Not Applicable
- Enrollment
- 136
- Primary Endpoint
- Change from Baseline in severity of nausea and vomiting at 21 days
Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •Patients will receive chemotherapy treatment which included Cisplatin, anthracycline or taxane during the study period.
- •ECOG score is between 0 and
- •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.
Outcomes
Primary Outcomes
Change from Baseline in severity of nausea and vomiting at 21 days
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
The severity of nausea and vomiting will be assessed by the Common Terminology Criteria for Adverse Events (CTCAE)
Secondary Outcomes
- 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.)
Investigators
Wang Xiaomin
Doctor
Beijing Hospital of Traditional Chinese Medicine
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