Comparative Effect Study Between Distal-proximal Point Association and Local Distribution Point Association in Chemotherapy-induced Nausea and Vomiting

Tianjin University of Traditional Chinese Medicine

Status: Unknown

Conditions: Chemotherapy-induced Nausea and Vomiting

Treatments: Other: Matching points PC6+CV12 plus antiemetic drug; Other: Matching points ST36+CV12 plus antiemetic drug; Drug: only antiemetic (Ramosetron, Tropisetron and dexamethasone); Other: Matching points CV13+CV12 plus antiemetic drug

Study type: Interventional

Funder types: Other

Identifiers

NCT02478047

2014CB543202-01

Details and patient eligibility

About

The purpose of this study is to clarify whether distal-proximal point association is more effective than partial match point association by electro-acupuncture in the management of chemotherapy-induced nausea and vomiting .

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Be diagnosed as cancer and need to accept chemotherapy.
2. The score of Karnofsky ≥70
3. Patients of either gender and older than 18 years
4. Patients receiving chemotherapy both outpatients and inpatients
5. Patients receiving chemotherapy either the first or multiple cycle, but the patient will be taken in only one time
6. To receive chemotherapy containing cisplatin(DDP≥75mg/m2) or joint chemotherapy programmes of Anthracyclines(Adriamycin≥40mg/m2 or epirubicin≥60mg/m2)
7. Life expectancy≥ 6 months
8. Willing to participate in the study and be randomized into one of the four study groups.

Exclusion criteria

1. To receive radiotherapy and chemotherapy
2. Gastrointestinal tumors
3. Patients with serious liver disease or abnormal hepatorenal function (AST,ACT, and TBIL are 3 times more than normal, BUN and Cr are 2 times more than normal)
4. Presence of cardiac pacemaker
5. Active skin infection
6. Nausea and/or vomiting resulting from opioids or metabolic imbalance (electrolyte disturbances)
7. Patients unable to provide self-care or communication
8. Nausea and/or vomiting resulting from mechanical risk factors (i.e., intestinal obstruction)
9. Brain metastases
10. Women in pregnant and lactating period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 4 patient groups

only antiemetic

Active Comparator group

Description:

The participants in the control group received standard antiemetic alone. Standard antiemetic for all groups is based on American Society of Clinical Oncology cClinical pPractice gGuideline. The 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron, Tropisetron) and dexamethasone are administered before the chemotherapy treatment.

Treatment:

Drug: only antiemetic (Ramosetron, Tropisetron and dexamethasone)

Matching points ST36+CV12

Experimental group

Treatment:

Other: Matching points ST36+CV12 plus antiemetic drug

Matching points PC6+CV12

Experimental group

Treatment:

Other: Matching points PC6+CV12 plus antiemetic drug

Matching points CV3+CV12

Experimental group

Treatment:

Other: Matching points CV13+CV12 plus antiemetic drug