| February 11, 2008 |
| February 21, 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) ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00621660 on ClinicalTrials.gov Archive Site |
| 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 ] [ Designated as safety issue: Yes ] |
| Same as current |
| |
| 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 |
| Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
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- Procedure: Acupuncture
- Procedure: Sham
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| |
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| Completed |
| 237 |
| 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.
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| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Sweden |
| |
| NCT00621660 |
| Senior Lecturer Sussanne Börjeson, Linkoeping University |
| 4960-B04-01XAC, 02-420, M167-04 |
| University Hospital, Linkoeping |
- The Swedish Cancer Society
- The County Council of Östergötland
- The Vardal Institute
- Cancer & Traffic Injury Fund
|
| Principal Investigator: |
Sussanne Börjeson, PhD |
Linköping University |
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| University Hospital, Linkoeping |
| November 2007 |
