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Acupuncture Versus Sham for Radiotherapy-Induced Emesis

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ClinicalTrials.gov Identifier: NCT00621660
Recruitment Status : Completed
First Posted : February 22, 2008
Last Update Posted : February 22, 2008
Sponsor:
Collaborators:
Swedish Cancer Society
Ostergotland County Council, Sweden
Vardalinstitutet The Swedish Institute for Health Sciences
Cancer & Traffic Injury Fund
Information provided by:
University Hospital, Linkoeping

February 11, 2008
February 22, 2008
February 22, 2008
January 2004
March 2007   (Final data collection date for primary outcome measure)
Number of patients with at least one episode of nausea during the whole radiotherapy treatment period [ Time Frame: The radiotherapy treatment period (md 5 weeks) ]
Same as current
No Changes Posted
Secondary outcome measures are the summed number of days with nausea, intensity of nausea, number of patients and summed number of days with vomiting, belief in the antiemetic effects and interest in receiving needling in the future [ Time Frame: From acupunture start until 4 weeks after treatment stopped ]
Same as current
Not Provided
Not Provided
 
Acupuncture Versus Sham for Radiotherapy-Induced Emesis
Acupuncture Compared To Sham With a Placebo-Needle in Radiotherapy-Induced Nausea - a Randomised Controlled Study
The aim of this study is to evaluate if acupuncture prevents or reduces nausea or vomiting during radiotherapy
Treatment with acupuncture is, despite sometimes unclear evidence, increasing in cancer care. Acupuncture is used for indications such as pain and nausea, but for radiotherapy (RT) induced nausea it is still an unexplored treatment. For evaluation of the method, the use of sham acupuncture as a control treatment provides a tool resembling placebo for drugs. The aim of the studt is therefore to investigate whether acupuncture reduces nausea caused by radiotherapy in a patient group with a >50% risk of experiencing the symptoms (abdominal or pelvic region). Patients are randomised to invasive acupuncture (IA) or placebo acupuncture (PA) 30 min, 2-3 times/week during the whole RT period. IA is administered bilaterally to the point PC6 using an invasive needle and PA with a needle, which looks identical but is not pointed and is not fixed in its handle. When this comes into contact with the surface of the skin and gives a feeling of penetration it glides upwards in its handle and is therefore shortened, which gives an illusion that the needle has entered the tissue. Nausea and vomiting is documented in diaries and questionnaires under the entire treatment period as well as two and four weeks after radiotherapy.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Nausea
  • Vomiting
  • 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.
    Other Name: Invasive acupuncture
  • 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.
    Other Names:
    • Sham acupuncture
    • Placebo acupuncture
  • Experimental: Acupuncture
    Intervention: Procedure: Acupuncture
  • Placebo Comparator: Sham
    Intervention: Procedure: Sham
Enblom A, Lekander M, Hammar M, Johnsson A, Onelöv E, Ingvar M, Steineck G, Börjeson S. Getting the grip on nonspecific treatment effects: emesis in patients randomized to acupuncture or sham compared to patients receiving standard care. PLoS One. 2011 Mar 23;6(3):e14766. doi: 10.1371/journal.pone.0014766.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
237
Same as current
March 2007
March 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients of at least 18 years of age
  • with gynaecologic-, anal-, rectal-, colon-, ventricle-, pancreatic- or testicular tumours
  • willing to give their informed consent
  • able to take part in the entire treatment and data collection procedure
  • had planned radiation over an abdominal and/or pelvic field (with or without concomitant chemotherapy) with the volume of at least 800 cm3 and a dose of at least 25 Gy.

Exclusion Criteria:

  • use of antiemetic treatment or persistent nausea within 24 hours prior to the start of radiotherapy
  • ever received acupuncture against nausea, or during the last year received acupuncture for any indication.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT00621660
4960-B04-01XAC
02-420
M167-04
Yes
Not Provided
Not Provided
Senior Lecturer Sussanne Börjeson, Linkoeping University
University Hospital, Linkoeping
  • Swedish Cancer Society
  • Ostergotland County Council, Sweden
  • Vardalinstitutet The Swedish Institute for Health Sciences
  • Cancer & Traffic Injury Fund
Principal Investigator: Sussanne Börjeson, PhD Linkoeping University
University Hospital, Linkoeping
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP