Acupuncture for Chemical Therapy Induced Nausea and Vomiting: a Cross-over Trail

Study Overview
=================
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.

Official Title
-----------------
Acupuncture for Chemical Therapy Induced Nausea and Vomiting: a Cross-over Trail

Conditions
-----------------
Chemotherapy-induced Nausea and Vomiting

Intervention / Treatment
-----------------
* Procedure: Manual acupuncture implemented by acupuncturist 1
* Procedure: Manual acupuncture implemented by acupuncturist 2


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A (Acupuncturist 1)<br>Manual acupuncture implemented by acupuncturist 1 (clinical experience >15 years) | Procedure: Manual acupuncture implemented by acupuncturist 1<br>* 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.<br>* Other names: Traditional acupuncture;|
| Active Comparator: B (Acupuncturist 2)<br>Manual acupuncture implemented by acupuncturist 2 (clinical experience < 5 years) | Procedure: Manual acupuncture implemented by acupuncturist 2<br>* 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.<br>* Other names: Traditional acupuncture;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NCI nausea and vomiting rating scale |  | day1-8 on each study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rhodes Scale |  | day1-5 on each study period | 
| global assessment on effectiveness by patients (VAS) |  | day 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chemotherapy, nausea, vomiting, cancer