Acupuncture Versus Sham for Radiotherapy-Induced Emesis

Nausea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00621660
• Other study ID #: 4960-B04-01XAC
• Secondary ID: 02-420M167-04
• Status: Completed
• Phase: N/A
• First received: February 11, 2008
• Last updated: February 21, 2008
• Start date: January 2004
• Est. completion date: March 2007

Study information

• Verified date: November 2007
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Nausea
• Vomiting

Intervention

Procedure:
• Acupuncture
Acupuncture was administered bilaterally to the standard antiemetic point2-4 pericardium six (PC6) located between the tendons of palmaris longus and flexor carpii radialis at two body-inches proximal of the wrist crease. Sharp needles, diameter 0.25 x length 40 millimetres, were inserted into a depth of a half body-inch. One body-inch (or a "cun" in traditional Chinese medicine context) is equivalent to the greatest width of the individual patients´ thumb at the distal phalanx, approximately one and a half centimetres or one American thumb. The needles were manipulated three times (at the start, middle and end of the treatment session) by twirling, thrusting and lifting until deqi occurred.
• Sham
Sham acupuncture was administered bilaterally to a non-acupuncture point two body-inches proximal of PC6 with the telescopic Park sham device16, 0.30 x 40 millimetres (fully extended length). That needle looks identical with a real needle but is blunted and glides upwards into its handle instead of penetrating, which gives an illusion of penetration. The marking tubes hold the needles in place. The therapist gave an illusion of manipulation by turning the needle three times, each time for a couple of seconds until the needle touched the skin, but no deqi occurred. Except when placing and manipulating the sham needle, it was not pressed against the skin at all.

Locations

Country	Name	City	State
Sweden	Sussanne Börjeson	Linköping

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Linkoeping	Cancer & Traffic Injury Fund, Ostergotland County Council, Sweden, Swedish Cancer Society, Vardalinstitutet The Swedish Institute for Health Sciences

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with at least one episode of nausea during the whole radiotherapy treatment period		The radiotherapy treatment period (md 5 weeks)	No
Secondary	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		From acupunture start until 4 weeks after treatment stopped	Yes