Acupuncture Versus Sham for Radiotherapy-Induced Emesis - Full Text View

Sponsors and Collaborators:	University Hospital, Linkoeping The Swedish Cancer Society The County Council of Östergötland The Vardal Institute The University Hospital of Linköping Cancer & Traffic Injury Fund
Information provided by:	University Hospital, Linkoeping
ClinicalTrials.gov Identifier:	NCT00621660

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

MedlinePlus related topics: Acupuncture Nausea and Vomiting

U.S. FDA Resources

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

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
Acupuncture: Experimental	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: Placebo Comparator	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.

Arms

Assigned Interventions

Acupuncture: Experimental

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: Placebo Comparator

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.

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

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

Locations

Sweden
Sussanne Börjeson
Linköping, Sweden, 58185

Sponsors and Collaborators

University Hospital, Linkoeping

The Swedish Cancer Society

The County Council of Östergötland

The Vardal Institute

The University Hospital of Linköping

Cancer & Traffic Injury Fund

Investigators

Principal Investigator:

Sussanne Börjeson, PhD

Linköping University

More Information

Responsible Party:	Linkoeping University ( Senior Lecturer Sussanne Börjeson )
Study ID Numbers:	4960-B04-01XAC, 02-420, M167-04
Study First Received:	February 11, 2008
Last Updated:	February 21, 2008
ClinicalTrials.gov Identifier:	NCT00621660
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by University Hospital, Linkoeping:

Acupuncture therapy
Cancer
Emesis
Expectations
Placebo

Study placed in the following topic categories:

Signs and Symptoms
Vomiting
Signs and Symptoms, Digestive
Clotrimazole

Miconazole
Tioconazole
Salicylhydroxamic acid
Nausea

Additional relevant MeSH terms:

Trypanocidal Agents
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents

Therapeutic Uses
Antifungal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009