Breast CancerNCT03232541
The Effects of Acupuncture and the Therapist´s Communication on Chemotherapy Induced Nausea and Vomiting
A study testing Genuine acupuncture in people with Breast Cancer and Colorectal Cancer, run by Västernorrland County Council, Sweden at 1 site in Sweden.
Trial summary
Background: Chemotherapy-induced nausea and vomiting (CINV) is a common and burdensome side-effect of emetogenic chemotherapy. CINV affects both the patient's quality of life and induces high costs within the health-care system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Bladder Cancer
- What is being tested?
- Genuine acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2017to 15 Aug 2025
- 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
- Breast, colorectal, bladder, or testicular cancer
- Receiving adjuvant or neo-adjuvant intravenous chemotherapy inducing medium or high risk for emesis
- Willing and capable to give their informed consent and to take part of the treatment and data collection procedure
Who cannot join
- Consumption of antiemetics or experiences of persistent nausea, which will persist within 24 hours prior to the start of the chemotherapy session
- Hemophilia
- Former participation in the same study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Acupuncture and the Therapist´s Communication on Chemotherapy Induced Nausea and Vomiting: a Randomized, Sham-controlled Trial
Background: Chemotherapy-induced nausea and vomiting (CINV) is a common and burdensome side-effect of emetogenic chemotherapy. CINV affects both the patient's quality of life and induces high costs within the health-care system. Many patients are interested in acupuncture, despite weak scrientific evidence for its effects beside non-specific effects. Few credibly sham-controlled studies have previously been conducted. The therapist's care and communication during acupuncture as well as during standard care may induce non-specific effects, such as placebo effects, potentially driven by the patient's expectations. It is not known if the type of communication, in terms of how positive the therapist communicates regarding expected effects, affects the effect of antiemetic treatments.
Aims: To investigate if CINV, treatment expectancy and quality of life differ between patients who receive A) standard care including antiemetics, B) standard care plus sham acupuncture or C) standard treatment plus genuine acupuncture by a therapist who emphasizes the positive expected outcomes of the treatment, compared to a therapist who communicates neutral regarding the expected outcomes.
Read more
Procedure: The eligible patients will be randomized to A) standard antiemetic treatment or to B) standard antiemetic treatment plus sham acupuncture or C) standard antiemetic treatment plus genuine acupuncture. Within the three groups, the patients are randomized to receive either neutral or positive communication from the therapist during the treatment.
Outcome measures: The primary outcome is intensity of nausea within the five days after the chemotherapy session in patients receiving positive or neutral communication. Data collection of nausea and vomiting, expectations, and quality of life is performed at baseline the day before the studied chemotherapy session, during 10 days after the studied chemotherapy session, and at a follow-up ten days after the last chemotherapy session.
Read the detailed description
Background: Chemotherapy-induced nausea and vomiting (CINV) is a common and burdensome side-effect of emetogenic chemotherapy. CINV affects both the patient's quality of life and induces high costs within the health-care system. Many patients are interested in acupuncture, despite weak scrientific evidence for its effects beside non-specific effects. Few credibly sham-controlled studies have previously been conducted. The therapist's care and communication during acupuncture as well as during standard antiemetic treatment may induce non-specific effects, such as placebo effects, potentially driven by the patient's expectations. It is not known if the type of communication, in terms of how positive the therapist communicates regarding expected effects, affects the effect of antiemetic treatments.
Aims: To investigate if CINV, treatment expectancy and quality of life differ between patients who receive A) standard antiemetic treatment, B) standard antiemetic treatment plus sham acupuncture or C) standard antiemetic treatment plus genuine acupuncture by a therapist who emphasizes the positive expected outcomes of the treatment, compared to a therapist who communicates neutral regarding the expected outcomes.
Procedure: Patients undergoing chemotherapy for cancer at three Swedish oncology departments will receive written and oral study information and are screened for study criteria. The eligible patients will be randomized to A) standard antiemetic treatment or to B) standard antiemetic treatment plus sham acupuncture or C) standard antiemetic treatment plus genuine acupuncture. Within the three groups, the patients are randomized to receive either neutral or positive communication from the therapist during the treatment.
Outcome measures: The primary outcome is intensity of nausea within the five days after the chemotherapy session in patients receiving positive or neutral communication. Data collection of nausea and vomiting, expectations, and quality of life is performed at baseline the day before the studied chemotherapy session, during 10 days after the studied chemotherapy session, and at a follow-up ten days after the last chemotherapy session.
Qualitative interviews regarding the patients' experiences of the communication with the professionals are conducted with a strategicaly selected group of patients from all randomization combinations. The selection aims to provide heterogenicity.
- Conditions
- Breast Cancer, Colorectal Cancer, Bladder Cancer, Chemotherapy-induced Nausea and Vomiting, Expectations
- Being tested
- Standard care, Sham acupuncture, Genuine acupuncture
- Keywords
- Chemotherapy-induced nausea and vomiting, Expectations
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Urinary Bladder Neoplasms, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard careOther
- Standard antiemetic treatment means receiving ordinary antiemetic medications. Within the group, the patients will be randomized to two communication types: 1) neutral communication or 2) strengthened positive communication regarding expected antiemetic effects of their treatment, using a standardized communication model.
Sham acupunctureDevice
- Sham acupuncture is administered bilaterally to a non-acupuncture point two body-inches proximal and one body-inch radial from PC6 using the telescopic Park Sham Device. The sham-needle is blunt and glides upward into its handle instead of penetrating. Marking tubes hold the needle in place. The therapist gives an illusion of manipulating the needle by turning it three times until it touches the skin, but no specific needle sensation ("deqi") will occur. Within the group, the patients will be randomized to two communication types: 1) neutral communication or 2) strengthened positive communication regarding expected antiemetic effects of their treatment, using a standardized communication model.
Genuine acupunctureDevice
- Acupuncture will be administered bilaterally to the standard antiemetic point PC6 located two body-inches proximal of the wrist crease, between the tendons of palmaris longus and flexor carpi radialis. Sharp acupuncture needles will be inserted into a depth of a half body-inch. The needles will be manipulated three times (at the start, middle and end of the treatment session) by twirling and lifting until deqi occurres. Within the group, the patients will be randomized to two communication types: 1) neutral communication or 2) strengthened positive communication regarding expected antiemetic effects of their treatment, using a standardized communication model.
| Study group | Role | What they receive |
|---|---|---|
| Standard care (A) | Other | Standard antiemetic treatment (A) with neutral communication (A1) or positive communication (A2) Receives: Other: Standard care |
| Sham acupuncture (B) | Placebo comparator | Standard antiemetic treatment plus Sham acupuncture (B) with neutral communication (B1) or positive communication (B2) Receives: Device: Sham acupuncture |
| Genuine acupuncture (C) | Experimental | Standard antiemetic treatment plus Genuine acupuncture (C) with neutral communication (C1) or positive communication (C2) Receives: Device: Genuine acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average nausea intensity day 1-5 (the day of the current chemotherapy session and the four following days).
Visual Analogue Scale (VAS).
Measured: In the morning of day 1-5 (the day of chemotherapy and the four following days).
Secondary outcomes (9)
The patient´s treatment expectations
Visual analogue scale (VAS)
Measured: Every morning day 1-10 (the day of the current chemotherapy session and the 10 following days).
Level of well-being
Visual analogue scale (VAS)
Measured: Four times: The day before the current chemotherapy session, 5 and 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.
Level of well-being
EQ-5D
Measured: Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.
Level of well-being
FACT-G
Measured: Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.
Level of activity
Verbal category scales
Measured: Four times: The day before the current chemotherapy session, 5 and 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.
Quality of life
Visual analogue scale (VAS)
Measured: Four times: The day before the current chemotherapy session, 5 and10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.
Quality of life
EQ-5D
Measured: Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.
Quality of life
FACT-G
Measured: Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.
Impact of nausea on daily activities
Visual analogue scale (VAS)
Measured: Two times: 5 and 10 days after the current chemotherapy session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start1 Sep 2017
- Primary completion23 Jun 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Västernorrland County Council, Sweden
- Sponsor type
- Other government
- Collaborators
- Falu Hospital, University of Gavle
- Responsible party
- Principal investigator, Ylva Widgren, Västernorrland County Council, Sweden
- Investigators
- Anna E Efverman, PhD, Principal investigator, University of Gavle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232541
- Sponsor's protocol ID
- Emesis 001
- Status last verified
- Aug 2025
- First submitted
- 24 Jul 2017
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sara L F, Ylva W, Marit S, Anna E. The Significance of Communication and Treatment Expectations in Cancer Care: An Interview Study With Cancer Care Practitioners. Integr Cancer Ther. 2025 Jan-Dec;24:15347354251370781. doi: 10.1177/15347354251370781. Epub 2025 Sep 19.
PubMed 40970276Ylva W, Per F, Erling E, Anna E. Design of a Randomized Sham-Controlled Trial: Strengthening Positive Treatment Expectations Using a Communication Model for Maximized Antiemetic Effects of Acupuncture and Antiemetics During Emetogenic Neo-/Adjuvant Chemotherapy. Integr Cancer Ther. 2025 Jan-Dec;24:15347354251361464. doi: 10.1177/15347354251361464. Epub 2025 Aug 22.
PubMed 40844814
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Acupuncture and the Therapist´s Communication on Chemotherapy Induced Nausea and Vomiting: a Randomized, Sham-controlled Trial
- ClinicalTrials.gov ID
- NCT03232541
- Acronym / sponsor ID
- Emesis 001
- Conditions
- Breast Cancer, Colorectal Cancer, Bladder Cancer, Chemotherapy-induced Nausea and Vomiting, Expectations
- Keywords
- Chemotherapy-induced nausea and vomiting, Expectations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Västernorrland County Council, SwedenOther government
- Collaborators
- Falu Hospital, University of Gavle
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 23 Jun 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 28 Jul 2017 (actual)
- 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.
Background: Chemotherapy-induced nausea and vomiting (CINV) is a common and burdensome side-effect of emetogenic chemotherapy. CINV affects both the patient's quality of life and induces high costs within the health-care system. Many patients are interested in acupuncture, despite weak scrientific evidence for its effects beside non-specific effects. Few credibly sham-controlled studies have previously been conducted. The therapist's care and communication during acupuncture as well as during standard care may induce non-specific effects, such as placebo effects, potentially driven by the patient's expectations. It is not known if the type of communication, in terms of how positive the therapist communicates regarding expected effects, affects the effect of antiemetic treatments.
Aims: To investigate if CINV, treatment expectancy and quality of life differ between patients who receive A) standard care including antiemetics, B) standard care plus sham acupuncture or C) standard treatment plus genuine acupuncture by a therapist who emphasizes the positive expected outcomes of the treatment, compared to a therapist who communicates neutral regarding the expected outcomes.
Procedure: The eligible patients will be randomized to A) standard antiemetic treatment or to B) standard antiemetic treatment plus sham acupuncture or C) standard antiemetic treatment plus genuine acupuncture. Within the three groups, the patients are randomized to receive either neutral or positive communication from the therapist during the treatment.
Outcome measures: The primary outcome is intensity of nausea within the five days after the chemotherapy session in patients receiving positive or neutral communication. Data collection of nausea and vomiting, expectations, and quality of life is performed at baseline the day before the studied chemotherapy session, during 10 days after the studied chemotherapy session, and at a follow-up ten days after the last chemotherapy session.
Detailed description
Background: Chemotherapy-induced nausea and vomiting (CINV) is a common and burdensome side-effect of emetogenic chemotherapy. CINV affects both the patient's quality of life and induces high costs within the health-care system. Many patients are interested in acupuncture, despite weak scrientific evidence for its effects beside non-specific effects. Few credibly sham-controlled studies have previously been conducted. The therapist's care and communication during acupuncture as well as during standard antiemetic treatment may induce non-specific effects, such as placebo effects, potentially driven by the patient's expectations. It is not known if the type of communication, in terms of how positive the therapist communicates regarding expected effects, affects the effect of antiemetic treatments.
Aims: To investigate if CINV, treatment expectancy and quality of life differ between patients who receive A) standard antiemetic treatment, B) standard antiemetic treatment plus sham acupuncture or C) standard antiemetic treatment plus genuine acupuncture by a therapist who emphasizes the positive expected outcomes of the treatment, compared to a therapist who communicates neutral regarding the expected outcomes.
Procedure: Patients undergoing chemotherapy for cancer at three Swedish oncology departments will receive written and oral study information and are screened for study criteria. The eligible patients will be randomized to A) standard antiemetic treatment or to B) standard antiemetic treatment plus sham acupuncture or C) standard antiemetic treatment plus genuine acupuncture. Within the three groups, the patients are randomized to receive either neutral or positive communication from the therapist during the treatment.
Outcome measures: The primary outcome is intensity of nausea within the five days after the chemotherapy session in patients receiving positive or neutral communication. Data collection of nausea and vomiting, expectations, and quality of life is performed at baseline the day before the studied chemotherapy session, during 10 days after the studied chemotherapy session, and at a follow-up ten days after the last chemotherapy session.
Qualitative interviews regarding the patients' experiences of the communication with the professionals are conducted with a strategicaly selected group of patients from all randomization combinations. The selection aims to provide heterogenicity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard care (A) | Other | Other: Standard careStandard antiemetic treatment (A) with neutral communication (A1) or positive communication (A2) |
| Sham acupuncture (B) | Placebo comparator | Device: Sham acupunctureStandard antiemetic treatment plus Sham acupuncture (B) with neutral communication (B1) or positive communication (B2) |
| Genuine acupuncture (C) | Experimental | Device: Genuine acupunctureStandard antiemetic treatment plus Genuine acupuncture (C) with neutral communication (C1) or positive communication (C2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of at least 18 years of age
- Breast, colorectal, bladder, or testicular cancer
- Receiving adjuvant or neo-adjuvant intravenous chemotherapy inducing medium or high risk for emesis
- Willing and capable to give their informed consent and to take part of the treatment and data collection procedure
Key exclusion criteria (3 listed)
- Consumption of antiemetics or experiences of persistent nausea, which will persist within 24 hours prior to the start of the chemotherapy session
- Hemophilia
- Former participation in the same study
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 |
|---|---|---|
| Standard careA) Standard antiemetic treatment means receiving ordinary antiemetic medications. Within the group, the patients will be randomized to two communication types: 1) neutral communication or 2) strengthened positive communication regarding expected antiemetic effects of their treatment, using a standardized communication model. | Other | Standard care (A) |
| Sham acupunctureB) Sham acupuncture is administered bilaterally to a non-acupuncture point two body-inches proximal and one body-inch radial from PC6 using the telescopic Park Sham Device. The sham-needle is blunt and glides upward into its handle instead of penetrating. Marking tubes hold the needle in place. The therapist gives an illusion of manipulating the needle by turning it three times until it touches the skin, but no specific needle sensation ("deqi") will occur. Within the group, the patients will be randomized to two communication types: 1) neutral communication or 2) strengthened positive communication regarding expected antiemetic effects of their treatment, using a standardized communication model. | Device | Sham acupuncture (B) |
| Genuine acupunctureC) Acupuncture will be administered bilaterally to the standard antiemetic point PC6 located two body-inches proximal of the wrist crease, between the tendons of palmaris longus and flexor carpi radialis. Sharp acupuncture needles will be inserted into a depth of a half body-inch. The needles will be manipulated three times (at the start, middle and end of the treatment session) by twirling and lifting until deqi occurres. Within the group, the patients will be randomized to two communication types: 1) neutral communication or 2) strengthened positive communication regarding expected antiemetic effects of their treatment, using a standardized communication model. | Device | Genuine acupuncture (C) |
Primary outcome
Average nausea intensity day 1-5 (the day of the current chemotherapy session and the four following days).
Time frame: In the morning of day 1-5 (the day of chemotherapy and the four following days).
Visual Analogue Scale (VAS).
9 secondary outcomes
The patient´s treatment expectations
Time frame: Every morning day 1-10 (the day of the current chemotherapy session and the 10 following days).
Level of well-being
Time frame: Four times: The day before the current chemotherapy session, 5 and 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.
Level of well-being
Time frame: Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.
Level of well-being
Time frame: Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.
Level of activity
Time frame: Four times: The day before the current chemotherapy session, 5 and 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.
Quality of life
Time frame: Four times: The day before the current chemotherapy session, 5 and10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.
Quality of life
Time frame: Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.
Quality of life
Time frame: Three times: The day before the current chemotherapy session, 10 days after the current chemotherapy session, and 10 days after the very last chemotherapy session.
Impact of nausea on daily activities
Time frame: Two times: 5 and 10 days after the current chemotherapy session.
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 24 Aug 2025.
- Derived from this study: PubMed 40970276Sara L F, Ylva W, Marit S, Anna E. The Significance of Communication and Treatment Expectations in Cancer Care: An Interview Study With Cancer Care Practitioners. Integr Cancer Ther. 2025 Jan-Dec;24:15347354251370781. doi: 10.1177/15347354251370781. Epub 2025 Sep 19.
- Derived from this study: PubMed 40844814Ylva W, Per F, Erling E, Anna E. Design of a Randomized Sham-Controlled Trial: Strengthening Positive Treatment Expectations Using a Communication Model for Maximized Antiemetic Effects of Acupuncture and Antiemetics During Emetogenic Neo-/Adjuvant Chemotherapy. Integr Cancer Ther. 2025 Jan-Dec;24:15347354251361464. doi: 10.1177/15347354251361464. Epub 2025 Aug 22.
- Individual participant dataSharing planned: No
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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.
Anna E Efverman, PhD principal investigator
University of Gavle
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genuine acupuncture in people with Breast Cancer and Colorectal Cancer, run by Västernorrland County Council, Sweden 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 4 inclusion and 3 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 24 Aug 2025. 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?
Average nausea intensity day 1-5 (the day of the current chemotherapy session and the four following days). (time frame: In the morning of day 1-5 (the day of chemotherapy and the four following days).). 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 NCT03232541, which also lists 2 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 24 Aug 2025.