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

Västernorrland County Council, Sweden

Status: Enrolling

Conditions: Breast Cancer; Bladder Cancer; Expectations; Chemotherapy-induced Nausea and Vomiting; Colorectal Cancer

Treatments: Device: Genuine acupuncture; Other: Standard care; Device: Sham acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03232541

Emesis 001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 198 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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198 participants in 3 patient groups, including a placebo group

Standard care (A)

Other group

Description:

Standard antiemetic treatment (A) with neutral communication (A1) or positive communication (A2)

Treatment:

Other: Standard care

Sham acupuncture (B)

Placebo Comparator group

Description:

Standard antiemetic treatment plus Sham acupuncture (B) with neutral communication (B1) or positive communication (B2)

Treatment:

Device: Sham acupuncture

Genuine acupuncture (C)

Experimental group

Description:

Standard antiemetic treatment plus Genuine acupuncture (C) with neutral communication (C1) or positive communication (C2)

Treatment:

Device: Genuine acupuncture