Acupuncture Versus Sham for Radiotherapy-Induced Emesis

NCT00621660 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 237

Last updated 2008-02-22

No results posted yet for this study

Summary

The aim of this study is to evaluate if acupuncture prevents or reduces nausea or vomiting during radiotherapy

Conditions

Interventions

PROCEDURE

Acupuncture

Acupuncture was administered bilaterally to the standard antiemetic point2-4 pericardium six (PC6) located between the tendons of palmaris longus and flexor carpii radialis at two body-inches proximal of the wrist crease. Sharp needles, diameter 0.25 x length 40 millimetres, were inserted into a depth of a half body-inch. One body-inch (or a "cun" in traditional Chinese medicine context) is equivalent to the greatest width of the individual patients´ thumb at the distal phalanx, approximately one and a half centimetres or one American thumb. The needles were manipulated three times (at the start, middle and end of the treatment session) by twirling, thrusting and lifting until deqi occurred.

PROCEDURE

Sham

Sham acupuncture was administered bilaterally to a non-acupuncture point two body-inches proximal of PC6 with the telescopic Park sham device16, 0.30 x 40 millimetres (fully extended length). That needle looks identical with a real needle but is blunted and glides upwards into its handle instead of penetrating, which gives an illusion of penetration. The marking tubes hold the needles in place. The therapist gave an illusion of manipulation by turning the needle three times, each time for a couple of seconds until the needle touched the skin, but no deqi occurred. Except when placing and manipulating the sham needle, it was not pressed against the skin at all.

Sponsors & Collaborators

  • Swedish Cancer Society

    collaborator OTHER
  • Ostergotland County Council, Sweden

    collaborator OTHER
  • Vardalinstitutet The Swedish Institute for Health Sciences

    collaborator OTHER
  • Cancer & Traffic Injury Fund

    collaborator UNKNOWN
  • University Hospital, Linkoeping

    lead OTHER

Principal Investigators

  • Sussanne Börjeson, PhD · Linkoeping University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2007-03-31
Completion
2007-03-31

Countries

  • Sweden

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00621660 on ClinicalTrials.gov