Acupuncture Versus Sham for Radiotherapy-Induced Emesis

NCT00621660 | Completed DMC

• 3 other identifiers: 4960-B04-01XAC02-420M167-04
• Study Type: interventional
• Target: 237
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nausea; Vomiting

Keywords

Acupuncture therapy; Cancer; Emesis; Expectations; Placebo

Outcome Measures

Primary Outcomes (1)

• Number of patients with at least one episode of nausea during the whole radiotherapy treatment period

  The radiotherapy treatment period (md 5 weeks)

Secondary Outcomes (1)

• 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

Study Arms (2)

Acupuncture

EXPERIMENTAL

Procedure: Acupuncture

Sham

PLACEBO COMPARATOR

Procedure: Sham

Interventions

Acupuncture 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.

Also known as: Invasive acupuncture

Acupuncture

Sham 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.

Also known as: Sham acupuncture, Placebo acupuncture

Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Linkoeping: lead
• Swedish Cancer Society: collaborator
• Ostergotland County Council, Sweden: collaborator
• Vardalinstitutet The Swedish Institute for Health Sciences: collaborator
• Cancer & Traffic Injury Fund: collaborator

Study Sites (1)

Sussanne Börjeson

Linköping, 58185, Sweden

Location

Related Publications (3)

• 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.

  PMID: 39300870 DERIVED

• 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.

  PMID: 32371667 DERIVED

• 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.

  PMID: 21448267 DERIVED

MeSH Terms

Conditions

Nausea; Vomiting; Neoplasms

Interventions

Acupuncture Therapy; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Sussanne Börjeson, PhD

  Linkoeping University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 11, 2008
• First Posted: February 22, 2008
• Study Start: January 1, 2004
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: February 22, 2008

Record last verified: 2007-11

Locations

SE (1)