The Effects of Acupuncture and the Therapist´s Communication on Chemotherapy Induced Nausea and Vomiting

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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 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. 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.

Official Title
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The Effects of Acupuncture and the Therapist´s Communication on Chemotherapy Induced Nausea and Vomiting: a Randomized, Sham-controlled Trial

Conditions
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Breast Cancer, Colorectal Cancer, Bladder Cancer, Testicular Cancer, Chemotherapy-induced Nausea and Vomiting

Intervention / Treatment
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* Other: Standard care
* Device: Sham acupuncture
* Device: Genuine acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard care (A)<br>Standard care (A) with neutral communication (A1) or positive communication (A2) | Other: Standard care<br>* A) Ordinary nausea 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.<br>|
| Placebo Comparator: Sham acupuncture (B)<br>Standard nausea treatment plus Sham acupuncture (B) with neutral communication (B1) or positive communication (B2) | Device: Sham acupuncture<br>* B) 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.<br>|
| Experimental: Genuine acupuncture (C)<br>Standard nausea treatment plus Genuine acupuncture (C) with neutral communication (C1) or positive communication (C2) | Device: Genuine acupuncture<br>* C) 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. |