Know Cancer

forgot password

Acupuncture Compared To Sham With a Placebo-Needle in Radiotherapy-Induced Nausea - a Randomised Controlled Study

18 Years
Not Enrolling
Nausea, Vomiting

Thank you

Trial Information

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.

Inclusion Criteria:

- patients of at least 18 years of age

- with gynaecologic-, anal-, rectal-, colon-, ventricle-, pancreatic- or testicular

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Number of patients with at least one episode of nausea during the whole radiotherapy treatment period

Outcome Time Frame:

The radiotherapy treatment period (md 5 weeks)

Safety Issue:


Principal Investigator

Sussanne Börjeson, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Linköping University


Sweden: Regional Ethical Review Board

Study ID:




Start Date:

January 2004

Completion Date:

March 2007

Related Keywords:

  • Nausea
  • Vomiting
  • Acupuncture therapy
  • Cancer
  • Emesis
  • Expectations
  • Placebo
  • Nausea
  • Vomiting