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

Not Applicable

• Conditions: Chemotherapy-induced Nausea and Vomiting
• Interventions: Drug: only antiemetic (Ramosetron, Tropisetron and dexamethasone); Other: Matching points ST36+CV12 plus antiemetic drug; Other: Matching points PC6+CV12 plus antiemetic drug; Other: Matching points CV13+CV12 plus antiemetic drug

• Registration Number: NCT02478047
• Lead Sponsor: Tianjin University of Traditional Chinese Medicine

Brief Summary

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 .

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-05
• Study First Submitted: 2015-05-19
• Study Start: 2015-06
• Study First Submitted QC: 2015-06-22
• Last Update Submitted: 2015-06-22
• Study First Posted: 2015-06-23
• Last Update Posted: 2015-06-23
• Primary Completion: 2016-06
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
only antiemetic	only antiemetic (Ramosetron, Tropisetron and dexamethasone)	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.
Matching points ST36+CV12	Matching points ST36+CV12 plus antiemetic drug	-
Matching points PC6+CV12	Matching points PC6+CV12 plus antiemetic drug	-
Matching points CV3+CV12	Matching points CV13+CV12 plus antiemetic drug	-

Primary Outcome Measures

Name	Time	Method
the frequency of Nausea and Vomiting	3 weeks
the extent of Nausea and Vomiting	3 weeks
Rhodes Index of Nausea, Vomiting and Retching	3 weeks

Secondary Outcome Measures

Name	Time	Method
the Anxiety and Depression of the patients	3 weeks
the condition of constipation and diarrhea	3 weeks
gastric electrical activity (electrogastrogram)	3 weeks
the life quality of the patients	3 weeks

Trial Locations

Locations (1)

Tianjin University of TCM; 🇨🇳 Tianjin, Tianjin, China