Clinical trial NCT00621660: Acupuncture Versus Sham for Radiotherapy-Induced Emesis
Official title: Acupuncture Compared To Sham With a Placebo-Needle in Radiotherapy-Induced Nausea - a Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nausea
Vomiting
Keywords: Acupuncture therapy
Cancer
Emesis
Expectations
Placebo
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
Collaborators: name: Swedish Cancer Society
name: Ostergotland County Council, Sweden
name: Vardalinstitutet The Swedish Institute for Health Sciences
name: Cancer & Traffic Injury Fund
First posted: 2008-02-22
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients with at least one episode of nausea during the whole radiotherapy treatment period
timeFrame: The radiotherapy treatment period (md 5 weeks)
Secondary outcomes:
measure: 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
timeFrame: From acupunture start until 4 weeks after treatment stopped
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Sussanne Börjeson
Study officials:
affiliation: Linkoeping University
name: Sussanne Börjeson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blom K, Efverman A. Sleep During Pelvic-Abdominal Radiotherapy for Cancer: A Longitudinal Study With Special Attention to Sleep in Relation to Nausea and Quality of Life. Cancer Nurs. 2021 Jul-Aug 01;44(4):333-344. doi: 10.1097/NCC.0000000000000826.
citation: Enblom A, Lekander M, Hammar M, Johnsson A, Onelov E, Ingvar M, Steineck G, Borjeson 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.