Investigating acupuncture and therapist communication effects 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
This study is testing if acupuncture and how well therapists communicate can help reduce nausea and vomiting in cancer patients undergoing chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 198 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Västernorrland County Council, Sweden Government |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Sundsvall) |
| Trial ID | NCT03232541 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the impact of acupuncture and therapist communication on chemotherapy-induced nausea and vomiting (CINV) among patients with breast, colorectal, and bladder cancers. Participants will be randomized into three groups: standard antiemetic treatment, standard treatment plus sham acupuncture, and standard treatment plus genuine acupuncture with varying levels of positive communication from the therapist. The study will assess differences in CINV, treatment expectancy, and quality of life. Conducted in three oncology departments in Sweden, the research seeks to provide insights into the potential benefits of acupuncture and the role of therapist communication in managing CINV.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with breast, colorectal, or bladder cancer undergoing chemotherapy with a medium to high risk of nausea.
Not a fit: Patients with persistent nausea prior to chemotherapy or those with hemophilia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the management of chemotherapy-induced nausea and vomiting, improving patients' quality of life.
How similar studies have performed: While acupuncture has been explored in other studies for CINV, this study's specific focus on therapist communication and its effects is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Sundsvall
- Sundsvall Hospital — Sundsvall, Sweden (Recruiting)
Study contacts
- Principal investigator: Anna E Efverman, PhD — University of Gavle
- Study coordinator: Ylva Widgren, MSP
- Email: ylva.widgren@hig.se
- Phone: +46 70 173 10 74
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.