NauseaNCT00621660
Acupuncture Versus Sham for Radiotherapy-Induced Emesis
A study testing Acupuncture in people with Nausea and Vomiting, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
The aim of this study is to evaluate if acupuncture prevents or reduces nausea or vomiting during radiotherapy Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 237 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2004to Mar 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acupuncture Compared To Sham With a Placebo-Needle in Radiotherapy-Induced Nausea - a Randomised Controlled Study
The aim of this study is to evaluate if acupuncture prevents or reduces nausea or vomiting during radiotherapy
Read the 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.
- Being tested
- Acupuncture, Sham
- Keywords
- Acupuncture therapy, Cancer, Emesis, Expectations, Placebo
- Medical subject headings
- Nausea, Vomiting, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Also called Invasive 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.
ShamProcedure or surgery
Also called Sham acupuncture, Placebo acupuncture
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.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Not described Receives: Procedure: Acupuncture |
| Sham | Placebo comparator | Not described Receives: Procedure: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with at least one episode of nausea during the whole radiotherapy treatment period
Measured: 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
Measured: From acupunture start until 4 weeks after treatment stopped
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startJan 2004
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for NauseaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Cancer Society, Ostergotland County Council, Sweden, Vardalinstitutet The Swedish Institute for Health Sciences, Cancer & Traffic Injury Fund
- Investigators
- Sussanne Börjeson, PhD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00621660
- Sponsor's protocol ID
- 4960-B04-01XAC
- Other IDs
- 02-420, M167-04
- Status last verified
- Nov 2007
- First submitted
- 11 Feb 2008
- Last updated
- 22 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 39300870Blom 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.
PubMed 32371667Enblom 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.
PubMed 21448267
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Compared To Sham With a Placebo-Needle in Radiotherapy-Induced Nausea - a Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT00621660
- Acronym / sponsor ID
- 4960-B04-01XAC
- Keywords
- Acupuncture therapy, Cancer, Emesis, Expectations, Placebo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Collaborators
- Swedish Cancer Society, Ostergotland County Council, Sweden, Vardalinstitutet The Swedish Institute for Health Sciences, Cancer & Traffic Injury Fund
- Study start
- Jan 2004
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 22 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Procedure: Acupuncture |
| Sham | Placebo comparator | Procedure: Sham |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAlso: Invasive acupunctureAcupuncture 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. | Procedure or surgery | Acupuncture |
| ShamAlso: Sham acupuncture, Placebo acupunctureSham 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. | Procedure or surgery | Sham |
Primary outcome
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)
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2008.
- Derived from this study: PubMed 39300870Efverman 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.
- Derived from this study: PubMed 32371667Blom 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.
- Derived from this study: PubMed 21448267Enblom 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.
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Nausea, Vomiting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sussanne Börjeson, PhD principal investigator
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Nausea and Vomiting, run by University Hospital, Linkoeping at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00621660, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2008.