Chemotherapy-induced Nausea and Vomiting Clinical Trial
Official title:
Acupuncture for Chemotherapy-Induced Nausea and Vomiting: A Randomized Clinical Trial
NCT number | NCT02195921 |
Other study ID # | 2014CB543201-02 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2015 |
Est. completion date | January 2017 |
Verified date | January 2021 |
Source | Tianjin University of Traditional Chinese Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 .
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 |
Country | Name | City | State |
---|---|---|---|
China | Tianjin University of Traditional Chinese Medicine | Tianjin | Tianjin |
Lead Sponsor | Collaborator |
---|---|
Tianjin University of Traditional Chinese Medicine |
China,
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 |
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