Skip to main content
OpenTrials
Completed

NCT Number: NCT02127255

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xiyuan Hospital, China Academy of Chinese Medical Sciences

Beijing, 100091, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manual acupuncture implemented by acupuncturist 1

Procedure

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

Manual acupuncture implemented by acupuncturist 2

Procedure

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

Primary outcomes

  1. NCI nausea and vomiting rating scale

    Time frame: day1-8 on each study period

Secondary outcomes

  1. Rhodes Scale

    Time frame: day1-5 on each study period

  2. global assessment on effectiveness by patients (VAS)

    Time frame: day 5 on each study period

  3. patients' confidence towards acupuncture treatment(VAS)

    Time frame: day 1,5 on each study period

  4. global satisfaction for acupuncture treatments

    Time frame: day 5 on each study period

  5. Acupuncture Expectancy Scale (AES)

    Time frame: day 1, 3, 5 on each study period

Other outcomes

  1. patient communication satisfaction scale

    Time frame: day 5 on each study period

  2. Acupuncture related adverse events

    Time frame: day 1-5 each study period

    faintng during acupuncture treatment, sticking of needle, bleeding in the needling hole, broken needles

  3. Adverse events (not acupuncture treatment specified)

    Time frame: day 1-5 each study period

  4. Needling manipulation parameters

    Time frame: day 1-5 each study period

    Displacement Frequency (Hz) Displacement Amplitude (pk-pk) Rotation Frequency (Hz) Rotation Amplitude (pk-pk)

Sponsors and collaborators

Lead sponsor

Beijing University of Chinese Medicine

Other

Collaborators

  • Xiyuan Hospital of China Academy of Chinese Medical Sciences

Registry information

Acronym: ACTIN

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 30, 2014
Registry last updated
Apr 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.