Bladder Cancer, Breast Cancer, Chemotherapy-induced Nausea and Vomiting, Colorectal Cancer, Expectations
Conditions
Keywords
Chemotherapy-induced nausea and vomiting, Expectations
Brief 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. 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.
Interventions
OTHERStandard care
A) 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.
DEVICESham acupuncture
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.
DEVICEGenuine acupuncture
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.
Sponsors
Falu Hospital
University of Gavle
Västernorrland County Council, Sweden
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
All other care providers beside the acupuncture/sham providing therapists are blinded to randomization group. For example, care providers providing the standard antiemetic treatment and the chemotherapy per se are blinded regarding randomization group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average nausea intensity day 1-5 (the day of the current chemotherapy session and the four following days). | In the morning of day 1-5 (the day of chemotherapy and the four following days). | Visual Analogue Scale (VAS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 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. | Visual analogue scale (VAS) |
| Impact of nausea on daily activities | Two times: 5 and 10 days after the current chemotherapy session. | Visual analogue scale (VAS) |
| The patient´s treatment expectations | Every morning day 1-10 (the day of the current chemotherapy session and the 10 following days). | Visual analogue scale (VAS) |
| Level of well-being | 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. | Visual analogue scale (VAS) |
| Level of activity | 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. | Verbal category scales |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cost-analyzes. | Emesis outcomes are measured every morning day 1-10 (the day of the current chemotherapy session and the 10 following days). | Costs per patient, in relation to emesis outcomes and in relation to quality of life. |
| Cortisol concentration | Two times: directly before and after the acupuncture or control intervention. | Saliva sample |
Countries
Sweden
Outcome results
None listed