Chemotherapy-induced Nausea and Vomiting
Conditions
Brief 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 .
Detailed 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.
Interventions
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.
OTHERsingle 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.
OTHERZusanli(ST36)and Zhongwan(CV12) plus antiemetic drug
Stimulating both Zusanli(ST36)and Zhongwan(CV12)
received routine antiemetic treatment
Sponsors
Tianjin University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Nausea and Number of Times of Vomiting Occurs After Chemotherapy | 5 days | 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. |
| Rhodes Index of Nausea, Vomiting and Retching | 5 days | 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 . |
| Percentage of Participants With Nausea | 5 days | 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. |
| Number of Times Vomiting Occurs After Chemotherapy | 5 days | The number of times vomiting occurs after chemotherapy for each participant during 0-120 hours. The evaluator completed daily diaries for each time point. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the Assessment of Quality of Life | 5 days | 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 |
| Grading of Constipation and Diarrhea | 5 days | The grading of constipation and diarrhea.We deleted this evaluation method due to weak correlation. |
| Electrogastrogram | 5 days | We deleted this evaluation method due to weak correlation. |
| the Assessment of Anxiety and Depression | 5 days | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood Routine Examination | 5 days | We deleted this evaluation method due to weak correlation. |
| Other Adverse Effect During the Chemotherapy | 5 days | — |
| Hepatic and Renal Function | 5 days | We deleted this evaluation method due to weak correlation. |
| Electrocardiogram | 5 days | We deleted this evaluation method due to weak correlation. |
Countries
China
Participant flow
Pre-assignment details
160 patients were enrolled randomly assigned to the CV12 (n = 40), ST36 (n = 40), DA (n = 40) and control (n = 40) groups. One participant in each of the CV12 and control groups was further excluded due to missing sessions, and one was excluded in the DA group because of repeated enrollment during the study period.
Participants by arm
| Arm | Count |
|---|---|
| Single Point CV12 choose single point:Zhongwan(CV12).Zhongwan(CV12):On the upper abdomen, 4 B-cun superior to the centre of the umbilicus, on the anterior median line.Manipulating until achieving a de Qi sensation,then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is 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 treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.
single point Neiguan(CV12) plus antiemetic drug | 40 |
| Single Point ST36 choose another single point Zusanli（ST36）.Zusanli(ST36):On the anterior aspect of the leg, on the line connecting ST35 with ST41, 3 B-cun inferior to ST35，located on the tibialis anterior muscle..Manipulating until achieving a de Qi sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is 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 treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.
single point Zusanli(ST36) plus antiemetic drug | 40 |
| Matching Points ST36+CV12 Choose both Zusanli(ST36) and Zhongwan（CV12）.Manipulating until achieving a de Qi sensation, then the needle is connected through a electro-acupuncture apparatus,the positive pole is linked to the needle, and the reference pole is 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 treatmeat is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.
matching points Zusanli(ST36)and Neiguan(CV12) plus antiemetic drug | 39 |
| Only Antiemetics The control group will receive standard antiemetics alone. Standard antiemetics for all groups are 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 chemtherapy,and lasting for 3-5days. If nausea and/or vomiting is persistent and failed to respond to the antiemetic treatment , based on the experience of each clinician, the other advanced 5-HT3 antagonist or a neurokinin 1 antagonist(NK-1) will be chosen.
only antiemetic drug | 40 |
| Total | 159 |
Baseline characteristics
| Characteristic | Single Point CV12 | Single Point ST36 | Matching Points ST36+CV12 | Only Antiemetics | Total |
|---|---|---|---|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 7.23 | 55.4 years STANDARD_DEVIATION 9.03 | 51.7 years STANDARD_DEVIATION 11.37 | 53.7 years STANDARD_DEVIATION 7.16 | 53 years STANDARD_DEVIATION 8.954 |
| Region of Enrollment China | 40 participants | 40 participants | 39 participants | 40 participants | 159 participants |
| Sex: Female, Male Female | 29 Participants | 26 Participants | 30 Participants | 29 Participants | 114 Participants |
| Sex: Female, Male Male | 11 Participants | 14 Participants | 9 Participants | 11 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 39 | 0 / 39 | 0 / 40 |
| other Total, other adverse events | 0 / 39 | 1 / 39 | 2 / 39 | 1 / 40 |
| serious Total, serious adverse events | 0 / 39 | 0 / 39 | 0 / 39 | 0 / 40 |
Outcome results
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.
Time frame: 5 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Single Point CV12 | Number of Times Vomiting Occurs After Chemotherapy | 0.44 number of times for patients |
| Single Point ST36 | Number of Times Vomiting Occurs After Chemotherapy | 0.54 number of times for patients |
| ST36+CV12 | Number of Times Vomiting Occurs After Chemotherapy | 0.78 number of times for patients |
| Only Antiemetics | Number of Times Vomiting Occurs After Chemotherapy | 0.53 number of times for patients |
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.
Time frame: 5 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Point CV12 | Percentage of Participants With Nausea | 31 percentage of participants |
| Single Point ST36 | Percentage of Participants With Nausea | 47 percentage of participants |
| ST36+CV12 | Percentage of Participants With Nausea | 54 percentage of participants |
| Only Antiemetics | Percentage of Participants With Nausea | 53 percentage of participants |
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.
Time frame: 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 .
Time frame: 5 days
Population: Data were not collected.Due to its relatively weak specificity, the data was not collected. we replaced it with (visual analog scale) VAS and number of times of vomiting occurs which were recorded in the first and second primary outcome.
Secondary
Electrogastrogram
We deleted this evaluation method due to weak correlation.
Time frame: 5 days
Population: Data were not collected
Secondary
Grading of Constipation and Diarrhea
The grading of constipation and diarrhea.We deleted this evaluation method due to weak correlation.
Time frame: 5 days
Population: Data were not collected
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.
Time frame: 5 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Single Point CV12 | the Assessment of Anxiety and Depression | 8 score on a scale |
| Single Point ST36 | the Assessment of Anxiety and Depression | 7 score on a scale |
| ST36+CV12 | the Assessment of Anxiety and Depression | 8 score on a scale |
| Only Antiemetics | the Assessment of Anxiety and Depression | 7 score on a scale |
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
Time frame: 5 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Single Point CV12 | the Assessment of Quality of Life | 47 score on a scale |
| Single Point ST36 | the Assessment of Quality of Life | 47 score on a scale |
| ST36+CV12 | the Assessment of Quality of Life | 45 score on a scale |
| Only Antiemetics | the Assessment of Quality of Life | 45 score on a scale |
Other Pre-specified
Blood Routine Examination
We deleted this evaluation method due to weak correlation.
Time frame: 5 days
Population: Data were not collected
Other Pre-specified
Electrocardiogram
We deleted this evaluation method due to weak correlation.
Time frame: 5 days
Population: Data were not collected
Other Pre-specified
Hepatic and Renal Function
We deleted this evaluation method due to weak correlation.
Time frame: 5 days
Population: Data were not collected
Other Pre-specified
Other Adverse Effect During the Chemotherapy
Time frame: 5 days
Population: Recorded in Adverse Events