Breast Cancer Clinical Trial
Official title:
The Effects of Acupuncture and the Therapist´s Communication on Chemotherapy Induced Nausea and Vomiting: a Randomized, Sham-controlled Trial
NCT number | NCT03232541 |
Other study ID # | Emesis 001 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | September 1, 2017 |
Est. completion date | June 2024 |
Background: Nausea and vomiting (emesis) is a common and burdensome side-effect of emetogenic chemotherapy. Emesis 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 chemotherapy-induced emesis, 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 care, including antiemetics or to B) standard treatment plus sham acupuncture or C) standard treatment plus genuine acupuncture. Within the three groups, the patients are randomized to receive either neutral or positive communication with 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.
Status | Recruiting |
Enrollment | 198 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Sundsvall Hospital | Sundsvall |
Lead Sponsor | Collaborator |
---|---|
Västernorrland County Council, Sweden | Falu Hospital, University of Gavle, Västervik Hospital |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Cost-analyzes. | Costs per patient, in relation to emesis outcomes and in relation to quality of life. | Emesis outcomes are measured every morning day 1-10 (the day of the current chemotherapy session and the 10 following days). | |
Primary | Average nausea intensity day 1-5 (the day of the current chemotherapy session and the four following days). | Visual Analogue Scale (VAS). | In the morning of day 1-5 (the day of chemotherapy and the four following days). | |
Secondary | The patient´s treatment expectations | Visual analogue scale (VAS) | Every morning day 1-10 (the day of the current chemotherapy session and the 10 following days). | |
Secondary | Level of well-being | VAS | 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. | |
Secondary | Level of well-being | Verbal category scales | 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. | |
Secondary | Level of well-being | EQ-5D | 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. | |
Secondary | Level of well-being | FACT-G | 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. | |
Secondary | Level of activity | VAS | 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. | |
Secondary | Level of activity | Verbal category scales | 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. | |
Secondary | Level of activity | EQ-5D | 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. | |
Secondary | Level of activity | FACT-G | 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. | |
Secondary | Quality of life | VAS | 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. | |
Secondary | Quality of life | Verbal category scales | 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. | |
Secondary | Quality of life | EQ-5D | 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. | |
Secondary | Quality of life | FACT-G | 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. |
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