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

NCT03232541 | Completed

• 1 other identifier: Emesis 001
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Chemotherapy-induced nausea and vomiting; Expectations

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• The patient´s treatment expectations

  Every morning day 1-10 (the day of the current chemotherapy session and the 10 following days).

• 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.

• Level of well-being

  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

  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

  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.

Other Outcomes (2)

• Cost-analyzes.

  Emesis outcomes are measured every morning day 1-10 (the day of the current chemotherapy session and the 10 following days).

• Cortisol concentration

  Two times: directly before and after the acupuncture or control intervention.

Study Arms (3)

Standard care (A)

OTHER

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

Other: Standard care

Sham acupuncture (B)

PLACEBO COMPARATOR

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

Device: Sham acupuncture

Genuine acupuncture (C)

EXPERIMENTAL

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

Device: Genuine acupuncture

Interventions

Genuine acupuncture DEVICE

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.

Genuine acupuncture (C)

Standard care OTHER

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.

Standard care (A)

Sham acupuncture DEVICE

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.

Sham acupuncture (B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Västernorrland County Council, Sweden: lead
• Falu Hospital: collaborator
• University of Gavle: collaborator

Study Sites (1)

Sundsvall Hospital

Sundsvall, SE-85186, Sweden

Location

Related Publications (1)

• Ylva W, Per F, Erling E, Anna E. Design of a Randomized Sham-Controlled Trial: Strengthening Positive Treatment Expectations Using a Communication Model for Maximized Antiemetic Effects of Acupuncture and Antiemetics During Emetogenic Neo-/Adjuvant Chemotherapy. Integr Cancer Ther. 2025 Jan-Dec;24:15347354251361464. doi: 10.1177/15347354251361464. Epub 2025 Aug 22.

  PMID: 40844814 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Urinary Bladder Neoplasms; Vomiting

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Anna E Efverman, PhD

  University of Gavle

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study coordinator

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: July 28, 2017
• Study Start: September 1, 2017
• Primary Completion: June 23, 2025
• Study Completion: August 15, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)