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

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.

Study Overview

• Status: Completed
• Conditions: Chemotherapy-induced Nausea and Vomiting
• Intervention / Treatment: Procedure: Manual acupuncture implemented by acupuncturist 1; Procedure: Manual acupuncture implemented by acupuncturist 2

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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100091
    • Xiyuan Hospital, China Academy of Chinese Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient communication satisfaction scale		day 5 on each study period
Acupuncture related adverse events	faintng during acupuncture treatment, sticking of needle, bleeding in the needling hole, broken needles	day 1-5 each study period
Adverse events (not acupuncture treatment specified)		day 1-5 each study period
Needling manipulation parameters	Displacement Frequency (Hz) Displacement Amplitude (pk-pk) Rotation Frequency (Hz) Rotation Amplitude (pk-pk)	day 1-5 each study period

Collaborators and Investigators

• Sponsor: Beijing University of Chinese Medicine
• Collaborators: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Investigators: Principal Investigator: Yutong Fei, MD, Beijing University of Chinese Medicine

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: April 29, 2014
• First Submitted That Met QC Criteria: April 29, 2014
• First Posted (Estimate): April 30, 2014

Study Record Updates

• Last Update Posted (Estimate): April 15, 2016
• Last Update Submitted That Met QC Criteria: April 14, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: chemotherapy; cancer; nausea; vomiting
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting
• Other Study ID Numbers: EBM@BUCM-1; Z111107054511086 (Other Grant/Funding Number: Beijing Nova Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED