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

Primary Purpose

Chemotherapy-induced Nausea and Vomiting

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Manual acupuncture implemented by acupuncturist 1
Manual acupuncture implemented by acupuncturist 2
Sponsored by
Beijing University of Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemotherapy-induced Nausea and Vomiting focused on measuring chemotherapy, nausea, vomiting, cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Xiyuan Hospital, China Academy of Chinese Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A (Acupuncturist 1)

B (Acupuncturist 2)

Arm Description

Manual acupuncture implemented by acupuncturist 1 (clinical experience >15 years)

Manual acupuncture implemented by acupuncturist 2 (clinical experience < 5 years)

Outcomes

Primary Outcome Measures

NCI nausea and vomiting rating scale

Secondary Outcome Measures

Rhodes Scale
global assessment on effectiveness by patients (VAS)
patients' confidence towards acupuncture treatment(VAS)
global satisfaction for acupuncture treatments
Acupuncture Expectancy Scale (AES)

Full Information

First Posted
April 29, 2014
Last Updated
April 14, 2016
Sponsor
Beijing University of Chinese Medicine
Collaborators
Xiyuan Hospital of China Academy of Chinese Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02127255
Brief Title
Acupuncture for Chemical Therapy Induced Nausea and Vomiting: a Cross-over Trail
Acronym
ACTIN
Official Title
Acupuncture for Chemical Therapy Induced Nausea and Vomiting: a Cross-over Trail
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing University of Chinese Medicine
Collaborators
Xiyuan Hospital of China Academy of Chinese Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Nausea and Vomiting
Keywords
chemotherapy, nausea, vomiting, cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A (Acupuncturist 1)
Arm Type
Active Comparator
Arm Description
Manual acupuncture implemented by acupuncturist 1 (clinical experience >15 years)
Arm Title
B (Acupuncturist 2)
Arm Type
Active Comparator
Arm Description
Manual acupuncture implemented by acupuncturist 2 (clinical experience < 5 years)
Intervention Type
Procedure
Intervention Name(s)
Manual acupuncture implemented by acupuncturist 1
Other Intervention Name(s)
Traditional manual acupuncture, Traditional acupuncture
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Manual acupuncture implemented by acupuncturist 2
Other Intervention Name(s)
Traditional manual acupuncture, Traditional acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
NCI nausea and vomiting rating scale
Time Frame
day1-8 on each study period
Secondary Outcome Measure Information:
Title
Rhodes Scale
Time Frame
day1-5 on each study period
Title
global assessment on effectiveness by patients (VAS)
Time Frame
day 5 on each study period
Title
patients' confidence towards acupuncture treatment(VAS)
Time Frame
day 1,5 on each study period
Title
global satisfaction for acupuncture treatments
Time Frame
day 5 on each study period
Title
Acupuncture Expectancy Scale (AES)
Time Frame
day 1, 3, 5 on each study period
Other Pre-specified Outcome Measures:
Title
patient communication satisfaction scale
Time Frame
day 5 on each study period
Title
Acupuncture related adverse events
Description
faintng during acupuncture treatment, sticking of needle, bleeding in the needling hole, broken needles
Time Frame
day 1-5 each study period
Title
Adverse events (not acupuncture treatment specified)
Time Frame
day 1-5 each study period
Title
Needling manipulation parameters
Description
Displacement Frequency (Hz) Displacement Amplitude (pk-pk) Rotation Frequency (Hz) Rotation Amplitude (pk-pk)
Time Frame
day 1-5 each study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yutong Fei, MD
Organizational Affiliation
Beijing University of Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xiyuan Hospital, China Academy of Chinese Medical Sciences
City
Beijing
ZIP/Postal Code
100091
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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