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

Not Applicable

Completed

• Conditions: Chemotherapy-induced Nausea and Vomiting
• Interventions: Procedure: Manual acupuncture implemented by acupuncturist 2; Procedure: Manual acupuncture implemented by acupuncturist 1

• Registration Number: NCT02127255
• Lead Sponsor: Beijing University of Chinese Medicine

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-29
• Study First Submitted QC: 2014-04-29
• Study First Posted: 2014-04-30
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-14
• Last Update Posted: 2016-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
B (Acupuncturist 2)	Manual acupuncture implemented by acupuncturist 2	Manual acupuncture implemented by acupuncturist 2 (clinical experience \< 5 years)
A (Acupuncturist 1)	Manual acupuncture implemented by acupuncturist 1	Manual acupuncture implemented by acupuncturist 1 (clinical experience \>15 years)

Primary Outcome Measures

Name	Time	Method
NCI nausea and vomiting rating scale	day1-8 on each study period

Secondary Outcome Measures

Name	Time	Method
global assessment on effectiveness by patients (VAS)	day 5 on each study period
Rhodes Scale	day1-5 on each study period
Acupuncture Expectancy Scale (AES)	day 1, 3, 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

Trial Locations

Locations (1)

Xiyuan Hospital, China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, China