Acupuncture Versus Sham for Radiotherapy-Induced Emesis

University Hospital, Linkoeping

Status

Completed

Conditions

Vomiting

Nausea

Treatments

Procedure: Sham

Procedure: Acupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT00621660

M167-04

4960-B04-01XAC

02-420

Details and patient eligibility

About

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

Full description

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.

Enrollment

237 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.