Clinical trial NCT02478047: Comparative Effect Study Between Distal-proximal Point Association and Local Distribution Point Association in Chemotherapy-induced Nausea and Vomiting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chemotherapy-induced Nausea and Vomiting
Keywords: to Evaluate the Effectiveness of Acupucnture in the Management of Chemotherapy-induced Nausea and Vomiting
Lead sponsor: Tianjin University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: National Basic Research Program, China
First posted: 2015-06-23
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .


Eligibility criteria: 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

Primary outcomes:
measure: the frequency of Nausea and Vomiting
timeFrame: 3 weeks
measure: the extent of Nausea and Vomiting
timeFrame: 3 weeks
measure: Rhodes Index of Nausea, Vomiting and Retching
timeFrame: 3 weeks
Secondary outcomes:
measure: the condition of constipation and diarrhea
timeFrame: 3 weeks
measure: gastric electrical activity (electrogastrogram)
timeFrame: 3 weeks
measure: the life quality of the patients
timeFrame: 3 weeks
measure: the Anxiety and Depression of the patients
timeFrame: 3 weeks
Other outcomes:
measure: the number of blood cells
timeFrame: 3 weeks
measure: cardial electrical activity
timeFrame: 3 weeks
measure: hepatic function
timeFrame: 3 weeks
measure: other adverse effect during the chemotherapy
timeFrame: 3 weeks
measure: renal function
timeFrame: 3 weeks
Locations:
city: Tianjin
country: China
facility: Tianjin University of TCM
state: Tianjin
Study officials:
References:
citation: Gao L, Chen B, Zhang Q, Zhao T, Li B, Sha T, Zou J, Guo Y, Pan X, Guo Y. Acupuncture with different acupoint combinations for chemotherapy-induced nausea and vomiting: study protocol for a randomized controlled trial. BMC Complement Altern Med. 2016 Nov 8;16(1):441. doi: 10.1186/s12906-016-1425-1.