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

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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Bladder Cancer
• Breast Cancer
• Chemotherapy-induced Nausea and Vomiting
• Colorectal Cancer
• Nausea
• Testicular Cancer
• Testicular Neoplasms
• Vomiting

• NCT number: NCT03232541
• Study type: Interventional
• Source: Västernorrland County Council, Sweden
• Contact: Ylva Widgren, MSP
• Phone: +46 70 173 10 74
• Email: ylva.widgren@hig.se
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2017
• Completion date: June 2024