Acupuncture Versus Sham for Radiotherapy-Induced Emesis

NCT ID: NCT00621660

Last Updated: 2008-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 237 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2007-03-31

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.

Conditions

Nausea; Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Acupuncture

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: PROCEDURE

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

Group Type: PLACEBO_COMPARATOR

Sham

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Invasive acupuncture; Sham acupuncture; Placebo acupuncture

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swedish Cancer Society

OTHER

Sponsor Role: collaborator

Ostergotland County Council, Sweden

OTHER

Sponsor Role: collaborator

Vardalinstitutet The Swedish Institute for Health Sciences

OTHER

Sponsor Role: collaborator

Cancer & Traffic Injury Fund

UNKNOWN

Sponsor Role: collaborator

University Hospital, Linkoeping

OTHER

Sponsor Role: lead

Responsible Party

Linkoeping University

Principal Investigators

Sussanne Börjeson, PhD

Role: PRINCIPAL_INVESTIGATOR

Linkoeping University

Locations

Sussanne Börjeson

Linköping, , Sweden

Countries

Sweden

References

Efverman A, Kristofferzon ML. A Basis for Strengthening Coping Strategies and Treatment Expectations in Patients Undergoing Emetogenic Pelvic-Abdominal Radiotherapy: A Longitudinal Study. Integr Cancer Ther. 2024 Jan-Dec;23:15347354241281329. doi: 10.1177/15347354241281329.

Reference Type: DERIVED

PMID: 39300870 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32371667 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21448267 (View on PubMed)

Other Identifiers

02-420

Identifier Type: -

Identifier Source: secondary_id

M167-04

Identifier Type: -

Identifier Source: secondary_id

4960-B04-01XAC

Identifier Type: -

Identifier Source: org_study_id