Chemotherapy-induced Nausea and Vomiting
Conditions
Keywords
Acupuncture, Expertise-based randomized controlled trial, Nausea, Vomiting, Cancer
Brief summary
This is an expertise-based randomized controlled trial. The hypothesis of this study is that the differences in expertise of acupuncturist may impact clinical effect. In this study, patients will be randomized to 4 group, receiving the treatment from senior acupuncturist, junior acupuncturist, junior acupuncturist by only acupuncture Neiguan(P6), or not receive the acupuncture. All patients receive the basic cisplatin chemotherapy. The duration of treatment is from the first day receiving cisplatin until two days after cisplatin on each group. NCI and Rhode scale will be used to measure the control of nausea and vomiting.
Detailed description
This is an expertise-based randomized controlled trial. The hypothesis of this study is that the differences in expertise of acupuncturist may impact clinical effect. In this study, 102 patients will be randomly divided into 4 groups which separately receiving the treatment from senior acupuncturist(clinical experience\> 15 years, considered in this trial as highly expertised), junior acupuncturist(clinical experience\< 5 years, considered in this trial as lower expertised), junior acupuncturist only acupuncture Neiguan(P6), or not receiving the acupuncture. All participants receive the cisplatin-based chemotherapy and 5-HT3 as antiemetic treatment will be included. Acupuncture treatments are given once daily, the duration of treatment is from the first day receiving cisplatin until two days after cisplatin. NCI and Rhode scale will be used to measure the control of nausea and vomiting. only outcome assessors are blinded. Generalized estimating equations will be used to compare the effects among groups.
Interventions
PROCEDUREManual acupuncture implemented by senior acupuncturists
Manual acupuncture once per day. No limitation on points, manipulations and time per session. Senior acupuncturists have to have more than 15 years of acupuncture clinical practice experience.
PROCEDUREManual acupuncture implemented by junior acupuncturists
Manual acupuncture once per day. No limitation on points, manipulations and time per session. Junior acupuncturists have to have less than 5 years of acupuncture clinical practice experience.
PROCEDUREManual acupuncture on P6 point
Manual acupuncture implemented by junior acupuncturists once per day. P6 point, bilaterally, should achieve deqi sensation by even manipulations. Junior acupuncturists have to have less than 5 years of acupuncture clinical practice experience.
Sponsors
Dongzhimen Hospital, Beijing
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing University of Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of cancer * Must receive cancer chemotherapy containing cisplatin * Use 5-TH receptor antagonists as an antiemetic drug in the chemotherapy duration
Exclusion criteria
* Concurrent neoplasms or illness that induces nausea independent of chemotherapy * Received acupuncture treatments for other conditions less than 4 weeks before chemotherapy treatment * Severe infection * Severe heart, liver, kidney and brain diseases * Cardiac pacemaker * Radiotherapy or hormone therapy during chemotherapy treatments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NCI nausea and vomiting rating scale | From the first day receiving cisplatin until two days after cisplatin in each group |
| Rhodes Scale | From the first day receiving cisplatin until two days after cisplatin in each group |
Secondary
| Measure | Time frame |
|---|---|
| Consumption of additional antiemetic | From the first day receiving cisplatin until two days after cisplatin |
| Patients' confidence towards acupuncture treatment (a single direct question with five levels of alternatives) | The first day receiving cisplatin and the second day after cisplatin |
| Global assessment on effectiveness by patients (a single direct question with five levels of alternatives) | The second day after cisplatin |
Other
| Measure | Time frame |
|---|---|
| Acupuncture related adverse events | From the first day receiving cisplatin until two days after cisplatin |
| Adverse events | From the first day receiving cisplatin until two days after cisplatin |
Countries
China
Outcome results
None listed