Clinical trial · Interventional
The Effects of Acupuncture and the Therapist´s Communication on Chemotherapy Induced Nausea and Vomiting
The Effects of Acupuncture and the Therapist´s Communication on Chemotherapy Induced Nausea and Vomiting: a Randomized, Sham-controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapy-induced Nausea and Vomiting | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Expectations | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Genuine acupuncture | Device | — | UNRESOLVED |
| Sham acupuncture | Device | — | UNRESOLVED |
| Standard care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- Standard care (A)
- description
- Standard antiemetic treatment (A) with neutral communication (A1) or positive communication (A2)
- interventionNames
- Other: Standard care
- type
- PLACEBO_COMPARATOR
- label
- Sham acupuncture (B)
- description
- Standard antiemetic treatment plus Sham acupuncture (B) with neutral communication (B1) or positive communication (B2)
- interventionNames
- Device: Sham acupuncture
- type
- EXPERIMENTAL
- label
- Genuine acupuncture (C)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (2)
- DERIVEDSara 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. PMID 40970276
- DERIVEDYlva 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. PMID 40844814