Acupuncture Versus Sham for Radiotherapy-Induced Emesis

This study has been completed.
Sponsor:
Collaborators:
Swedish Cancer Society
Ostergotland County Council, Sweden
Vardalinstitutet The Swedish Institute for Health Sciences
Cancer & Traffic Injury Fund
Information provided by:
University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT00621660
First received: February 11, 2008
Last updated: February 21, 2008
Last verified: November 2007
  Purpose

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


Condition Intervention
Nausea
Vomiting
Procedure: Acupuncture
Procedure: Sham

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture Compared To Sham With a Placebo-Needle in Radiotherapy-Induced Nausea - a Randomised Controlled Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 237
Study Start Date: January 2004
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture 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.
Other Name: Invasive acupuncture
Placebo Comparator: Sham Procedure: 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.
Other Names:
  • Sham acupuncture
  • Placebo acupuncture

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621660

Locations
Sweden
Sussanne Börjeson
Linköping, Sweden, 58185
Sponsors and Collaborators
University Hospital, Linkoeping
Swedish Cancer Society
Ostergotland County Council, Sweden
Vardalinstitutet The Swedish Institute for Health Sciences
Cancer & Traffic Injury Fund
Investigators
Principal Investigator: Sussanne Börjeson, PhD Linköping university
  More Information

No publications provided by University Hospital, Linkoeping

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Senior Lecturer Sussanne Börjeson, Linkoeping University
ClinicalTrials.gov Identifier: NCT00621660     History of Changes
Other Study ID Numbers: 4960-B04-01XAC, 02-420, M167-04
Study First Received: February 11, 2008
Last Updated: February 21, 2008
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by University Hospital, Linkoeping:
Acupuncture therapy
Cancer
Emesis
Expectations
Placebo

Additional relevant MeSH terms:
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on October 16, 2014