The Effect of Acupuncture in Chemotherapy-induced Nausea and Vomiting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Chemotherapy-induced Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Verum acupuncture and medicine

Intervention Type OTHER

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).

Group Type SHAM_COMPARATOR

Sham acupuncture and medicine

Intervention Type OTHER

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).

Interventions

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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).

Intervention Type 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).

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No