Clinical trial NCT03232541: The Effects of Acupuncture and the Therapist´s Communication on Chemotherapy Induced Nausea and Vomiting
Official title: The Effects of Acupuncture and the Therapist´s Communication on Chemotherapy Induced Nausea and Vomiting: a Randomized, Sham-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Colorectal Cancer
Bladder Cancer
Chemotherapy-induced Nausea and Vomiting
Expectations
Keywords: Chemotherapy-induced nausea and vomiting
Expectations
Lead sponsor: Västernorrland County Council, Sweden
Sponsor class: OTHER_GOV
Collaborators: name: Falu Hospital
name: University of Gavle
First posted: 2017-07-28
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Average nausea intensity day 1-5 (the day of the current chemotherapy session and the four following days).
timeFrame: In the morning of day 1-5 (the day of chemotherapy and the four following days).
Secondary outcomes:
measure: The patient´s treatment expectations
timeFrame: Every morning day 1-10 (the day of the current chemotherapy session and the 10 following days).
measure: Level of well-being
timeFrame: 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.
measure: Level of well-being
timeFrame: 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.
measure: Level of well-being
timeFrame: 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.
measure: Level of activity
timeFrame: 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.
measure: Quality of life
timeFrame: 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.
measure: Quality of life
timeFrame: 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.
measure: Quality of life
timeFrame: 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.
measure: Impact of nausea on daily activities
timeFrame: Two times: 5 and 10 days after the current chemotherapy session.
Other outcomes:
measure: Cost-analyzes.
timeFrame: Emesis outcomes are measured every morning day 1-10 (the day of the current chemotherapy session and the 10 following days).
measure: Cortisol concentration
timeFrame: Two times: directly before and after the acupuncture or control intervention.
Locations:
city: Sundsvall
country: Sweden
facility: Sundsvall Hospital
Study officials:
affiliation: University of Gavle
name: Anna E Efverman, PhD
role: PRINCIPAL_INVESTIGATOR
References: