Acupuncture Compared To Sham With a Placebo-Needle in Radiotherapy-Induced Nausea - a Randomised Controlled Study
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
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Number of patients with at least one episode of nausea during the whole radiotherapy treatment period
The radiotherapy treatment period (md 5 weeks)
No
Sussanne Börjeson, PhD
Principal Investigator
Linköping University
Sweden: Regional Ethical Review Board
4960-B04-01XAC
NCT00621660
January 2004
March 2007
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