Chemotherapy-induced Nausea and Vomiting
Conditions
Keywords
chemotherapy, nausea, vomiting, cancer
Brief summary
This is a randomized, controlled cross-over trial. The hypothesis of this study is that the differences in manual acupuncture manipulation can impact clinical effect though the acupuncturists follow the same needling regimen. In this study, acupuncturist 1 (clinical experience \>15 years) and acupuncturist 2 (\<5 years) will give treatments to cancer patients receiving cisplatin chemotherapy (n=36) for at least two continuous cycles, once per day, 5 days per cycle. Acupuncturist 1 determines all the treatment regimens (selection of acupoints and methods of needling manipulation, needle retention time). Randomly, half of the patients will receive treatments from acupuncturist 1 in the first treatment cycle and from acupuncturist 2 in the second cycle; while the other half will be treated in other way round. There is a washout period (21 days) between two cycles. The needling manipulation of two acupuncturists will be measured objectively during treatments. The clinical effect will be measured by the control of vomiting and nausea during and after chemotherapy treatments.
Detailed description
This is a randomized, controlled cross-over trial. The hypothesis of this study is that the differences in manual acupuncture manipulation can impact clinical effect though the acupuncturists follow the same needling regimen. In this study, acupuncturist 1 (clinical experience \>15 years) and acupuncturist 2 (\<5 years) will give treatments to cancer patients receiving cisplatin chemotherapy (n=36) for at least two continuous cycles, once per day, 5 days per cycle. Acupuncturist 1 determines all the treatment regimens (selection of acupoints and methods of needling manipulation, needle retention time). Randomly, half of the patients will receive treatments from acupuncturist 1 in the first treatment cycle and from acupuncturist 2 in the second cycle; while the other half will be treated in other way round. There is a washout period (21 days) between two cycles. The needling manipulation of two acupuncturists will be measured objectively during treatments. The clinical effect will be measured by the control of vomiting and nausea during and after chemotherapy treatments. The manual manipulation of two acupuncturists will be recorded by device Acusensor.
Interventions
PROCEDUREManual acupuncture implemented by acupuncturist 1
Manual acupuncture once per day. Acupuncture treatment regimens (acupoints, needling methods, needle retention time) were decided by acupuncturist 1 according to the syndrome differentiation of patients. Acupuncturist 1 has to have more than 15 years of acupuncture clinical practice experience.
PROCEDUREManual acupuncture implemented by acupuncturist 2
Manual acupuncture given by acupuncturist 2 once per day. Acupuncture treatment regimens (acupoints, needling methods, needle retention time) were decided by acupuncturist 1 according to the syndrome differentiation of patients. Acupuncturist 2 has to have less than 5 years of acupuncture clinical practice experience.
Sponsors
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing University of Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of cancer * Must receive cancer chemotherapy containing cisplatin * Able to complete at least two continuous chemotherapy treatment cycles * Karnofsky performance status grade ≥60 * Must 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 * Receiving radiotherapy * Received acupuncture treatments for other conditions less than 4 weeks before chemotherapy treatment * Severe infection * Severe heart, liver, kidney and brain diseases * Unconsciousness * Psychosis * Language barriers * Cardiac pacemaker * Radiotherapy or hormone therapy during chemotherapy treatments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NCI nausea and vomiting rating scale | day1-8 on each study period |
Secondary
| Measure | Time frame |
|---|---|
| global assessment on effectiveness by patients (VAS) | day 5 on each study period |
| Rhodes Scale | day1-5 on each study period |
| patients' confidence towards acupuncture treatment(VAS) | day 1,5 on each study period |
| global satisfaction for acupuncture treatments | day 5 on each study period |
| Acupuncture Expectancy Scale (AES) | day 1, 3, 5 on each study period |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (not acupuncture treatment specified) | day 1-5 each study period | — |
| Needling manipulation parameters | day 1-5 each study period | Displacement Frequency (Hz) Displacement Amplitude (pk-pk) Rotation Frequency (Hz) Rotation Amplitude (pk-pk) |
| Acupuncture related adverse events | day 1-5 each study period | faintng during acupuncture treatment, sticking of needle, bleeding in the needling hole, broken needles |
| patient communication satisfaction scale | day 5 on each study period | — |
Countries
China
Outcome results
None listed