Acupuncture for Chemotherapy-Induced Nausea and Vomiting

Chemotherapy-induced Nausea and Vomiting Clinical Trial

Official title:

Acupuncture for Chemotherapy-Induced Nausea and Vomiting: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02195921
• Other study ID #: 2014CB543201-02
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: January 2017

Study information

• Verified date: January 2021
• Source: Tianjin University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to clarify whether the matching acupoints is more effective than a single point by electroacupuncture in the management of chemotherapy-induced nausea and vomiting .

Description:

Patients were assigned to Four sessions of electroacupuncture(EA) at the CV12, ST36, CV12+ST36 acupoints or antiemetic therapy over 5 days. primary and secondary outcomes and Adverse Eventswill be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 he 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

Related Conditions & MeSH terms

• Chemotherapy-induced Nausea and Vomiting
• Nausea
• Vomiting

Intervention

Other:
• single point Zhongwan(CV12) plus antiemetic drug
All participants were supine in the hospital bed. A disposable sterile acupuncture needle (ø 0.30 × 40 mm, Hwato) was inserted vertically at approximately 20-30 mm until "De Qi" (sensation of soreness, numbness, distension, etc. around the acupoint) was reported by the participants. Then, the needle handle was clamped via a metal clip to connect to the positive electrode of the electric acupuncture apparatus (Huatuo, SDZ-V model, Suzhou Medical Appliance). Another reference electrode was placed 1 cm above the CV12 acupoints of the stimulation point, where no acupoints or meridians passed through. A dilatational wave at a frequency of 2/10 Hz and a current intensity at the highest level tolerated by the patient, with a maximum intensity no more than 10 mA, were used to deliver the EA stimulation. People in the intervention groups were offered a standardized 30-minute EA session once daily from the 1st day of the four-day chemotherapy cycle.
• single point Zusanli(ST36) plus antiemetic drug
A disposable sterile acupuncture needle (ø 0.30 × 40 mm, Hwato) was inserted vertically at approximately 20-30 mm until "De Qi" (sensation of soreness, numbness, distension, etc. around the acupoint) was reported by the participants. Then, the needle handle was clamped via a metal clip to connect to the positive electrode of the electric acupuncture apparatus (Huatuo, SDZ-V model, Suzhou Medical Appliance). Another reference electrode was placed 1cm below ST36 acupoints of the stimulation point, respectively, where no acupoints or meridians passed through. A dilatational wave at a frequency of 2/10 Hz and a current intensity at the highest level tolerated by the patient, with a maximum intensity no more than 10 mA, were used to deliver the EA stimulation. People in the intervention groups were offered a standardized 30-minute EA session once daily from the 1st day of the four-day chemotherapy cycle.
• Zusanli(ST36)and Zhongwan(CV12) plus antiemetic drug
Stimulating both Zusanli(ST36)and Zhongwan(CV12)

Drug:
• only antiemetic drug
received routine antiemetic treatment

Locations

Country	Name	City	State
China	Tianjin University of Traditional Chinese Medicine	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood Routine Examination	We deleted this evaluation method due to weak correlation.	5 days
Other	Electrocardiogram	We deleted this evaluation method due to weak correlation.	5 days
Other	Hepatic and Renal Function	We deleted this evaluation method due to weak correlation.	5 days
Other	Other Adverse Effect During the Chemotherapy		5 days
Primary	Percentage of Participants With Nausea	Percentage of participants with nausea was assessed by visual analog scale (VAS) ranging from 0 (no nausea) to 10 (worst nausea). A score of 0 means no nausea for a portion of the patient's assessment.	5 days
Primary	Number of Times Vomiting Occurs After Chemotherapy	The number of times vomiting occurs after chemotherapy for each participant during 0-120 hours. The evaluator completed daily diaries for each time point.	5 days
Primary	Rhodes Index of Nausea, Vomiting and Retching	The RINVR scale has 8 items . The scale divides the occurrence of nausea , vomiting , and retching within 12 hours of tumor chemotherapy patients into 5 grades , which are scored from 0 to 4 points . The lower the score , the better . The RINVR scale can be divided into three dimensions : symptom experience time , symptom frequency and symptom severity .	5 days
Primary	Percentage of Participants With Nausea and Number of Times of Vomiting Occurs After Chemotherapy	Rhodes Index of Nausea, Vomiting and Retching was replaced by percentage of participants with nausea (assessed by VAS) and number of times of vomiting occurs which were recorded in the first and second primary outcome.	5 days
Secondary	Grading of Constipation and Diarrhea	The grading of constipation and diarrhea.We deleted this evaluation method due to weak correlation.	5 days
Secondary	Electrogastrogram	We deleted this evaluation method due to weak correlation.	5 days
Secondary	the Assessment of Quality of Life	Assessed by the Functional Assessment of Cancer Treatment-General (FACT-G) .The FACT-G includes 27 items and is divided among 4 subscales: physical well-being (PWB), functional well-being (FWB), social/family well-being (SWB), and emotional well-being (EWB). The total FACT-G score ranges from 0 to 108 and is calculated by the sum of the subscales, with higher scores indicating greater functional status	5 days
Secondary	the Assessment of Anxiety and Depression	Assessed by Hospital Anxiety and Depression Scale (HADS scale). It includes fourteen items, seven of which assess anxiety and the other seven assess depression (30). The total scores range from 0 to 21 for depression and anxiety, respectively, with higher scores indicating more depression and anxiety.	5 days