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

NCT02478047 | Unknown DMC

• 1 other identifier: 2014CB543202-01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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 .

Conditions

Chemotherapy-induced Nausea and Vomiting

Keywords

to Evaluate the Effectiveness of Acupucnture in the Management of Chemotherapy-induced Nausea and Vomiting

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• the condition of constipation and diarrhea

  3 weeks

• gastric electrical activity (electrogastrogram)

  3 weeks

• the life quality of the patients

  3 weeks

• the Anxiety and Depression of the patients

  3 weeks

Other Outcomes (5)

• the number of blood cells

  3 weeks

• cardial electrical activity

  3 weeks

• hepatic function

  3 weeks

Study Arms (4)

only antiemetic

ACTIVE COMPARATOR

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.

Drug: only antiemetic (Ramosetron, Tropisetron and dexamethasone)

Matching points ST36+CV12

EXPERIMENTAL

Other: Matching points ST36+CV12 plus antiemetic drug

Matching points PC6+CV12

EXPERIMENTAL

Other: Matching points PC6+CV12 plus antiemetic drug

Matching points CV3+CV12

EXPERIMENTAL

Other: Matching points CV13+CV12 plus antiemetic drug

Interventions

only antiemetic (Ramosetron, Tropisetron and dexamethasone) DRUG

The control group will receive standard antiemetic alone. Standard antiemetic for all groups is based on American Society of Clinical Oncology clinical practice guideline. 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron, Tropisetron) and dexamethasone are supplied from the first day of chemotherapy, and lasting for 3-5 days.And plus antiemetic drug as the comparator group.

only antiemetic

Matching points ST36+CV12 plus antiemetic drug OTHER

Choose both Zusanli(ST36) and Zhongwan point(CV12). Manipulating until achieving a "de Qi" sensation, then the needles are connected through a electro-acupuncture apparatus, the positive poles are linked to the needle, and the reference poles are located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA. The operation lasts for 30 min. The treatment is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.And plus antiemetic drug as the comparator group.

Matching points ST36+CV12

Matching points PC6+CV12 plus antiemetic drug OTHER

Choose both Neiguan(PC6) and Zhongwan point(CV12). Manipulating until achieving a "de Qi" sensation, then the needles are connected through a electro-acupuncture apparatus, the positive poles are linked to the needle, and the reference poles are located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA. The operation lasts for 30 min. The treatment is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.And plus antiemetic drug as the comparator group.

Matching points PC6+CV12

Matching points CV13+CV12 plus antiemetic drug OTHER

Choose both Shangwan(CV13) and Zhongwan point(CV12). Manipulating until achieving a "de Qi" sensation, then the needles are connected through a electro-acupuncture apparatus, the positive poles are linked to the needle, and the reference poles are located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA. The operation lasts for 30 min. The treatment is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.And plus antiemetic drug as the comparator group.

Matching points CV3+CV12

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• To receive radiotherapy and chemotherapy
• Gastrointestinal tumors
• 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)
• Presence of cardiac pacemaker
• Active skin infection
• Nausea and/or vomiting resulting from opioids or metabolic imbalance (electrolyte disturbances)
• Patients unable to provide self-care or communication
• Nausea and/or vomiting resulting from mechanical risk factors (i.e., intestinal obstruction)
• Brain metastases
• Women in pregnant and lactating period

Sponsors & Collaborators

• Tianjin University of Traditional Chinese Medicine: lead
• National Basic Research Program, China: collaborator

Study Sites (1)

Tianjin University of TCM

Tianjin, Tianjin Municipality, 300193, China

Location

Related Publications (1)

• 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.

  PMID: 27821107 DERIVED

MeSH Terms

Conditions

Vomiting

Interventions

ramosetron; Tropisetron; Dexamethasone; Antiemetics

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Gastrointestinal Agents

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: the Dean of Acupuncture and Moxibustion College

Study Record Dates

• First Submitted: May 19, 2015
• First Posted: June 23, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: September 1, 2016
• Last Updated: June 23, 2015

Record last verified: 2015-05

Locations

CN (1)