The Effect of Acupuncture in Chemotherapy-induced Nausea and Vomiting

Beijing Hospital of Traditional Chinese Medicine

Status: Unknown

Conditions: Chemotherapy-induced Nausea and Vomiting

Treatments: Other: Verum acupuncture and medicine; Other: Sham acupuncture and medicine

Study type: Interventional

Funder types: Other

Identifiers

NCT02369107

XM201410

Details and patient eligibility

About

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

Enrollment: 136 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

Verum acupuncture and medicine

Experimental group

Description:

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).

Treatment:

Other: Verum acupuncture and medicine

Sham acupuncture and medicine

Sham Comparator group

Description:

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).

Treatment:

Other: Sham acupuncture and medicine