- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06769165
EMDR Treatment of Conditioned Nausea and Vomiting in Cancer Survivors (EMESIS)
December 4, 2025 updated by: University Medical Center Groningen
EMDR Treatment of Conditioned Nausea and Vomiting in Cancer Survivors - a Pilot Study
To explore the effectiveness of EMDR therapy treatment in reducing symptoms of chemotherapy-induced conditioned nausea and vomiting in (former) patients with cancer.
Study Overview
Detailed Description
Conditioned nausea and vomiting is a common side effect of anti-cancer treatment, and while strategies like antiemetics exist, their effectiveness is limited.
Conditioned nausea and vomiting can possibly be addressed through Eye Movement Desensitization and Reprocessing (EMDR) therapy.
EMDR therapy is a therapeutic intervention, proven to be effective in the treatment of post-traumatic stress disorder (PTSD), and promising in treating a range of other conditions.
At the UMCG, EMDR therapy is used on a small scale to treat conditioned nausea with positive results, although more rigorous research is needed to fully establish its efficacy.
This study aims to explore the effectiveness of EMDR therapy treatment in reducing symptoms of chemotherapy-induced conditioned nausea and vomiting in (former) patients with cancer.
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jacco J de Haan, MD, PhD
- Phone Number: +31503616161
- Email: j.j.de.haan@umcg.nl
Study Locations
-
-
Provincie Groningen
-
Groningen, Provincie Groningen, Netherlands, 9713 GZ
- Recruiting
- University Medical Center Groningen
-
Principal Investigator:
- Jacco J de Haan, MD, PhD
-
Contact:
- Jacco J de Haan, MD, PhD
- Phone Number: +31 50 361 61 61
- Email: j.j.de.haan@umcg.nl
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Previously pathologically confirmed diagnosis of cancer
- Previously treated with systemic cancer therapy
- Persistent complaints (more than 2 months) of conditioned nausea and/or vomiting
- Able to understand spoken and written Dutch
- 18 years or older
Exclusion Criteria:
- Ongoing psychiatric treatment
- EMDR therapy contraindications (dissociative disorders, personality disorders or severe somatic disorders (e.g. cardiac arrhythmias))
- Complex type 2 trauma
- Known with recent conditions / non-anti-cancer medication which can elicit nausea (e.g. pregnancy or alcohol abuses)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: EMDR Therapy
EMDR therapy sessions with a trained psychologist.
|
In this study, EMDR therapy will be performed by psychologists of the UMCG who are trained in EMDR therapy and who have experience with patients with somatic diseases.
In the EMDR therapy protocol, the patient is guided through eight phases which incorporate dual focus of attention and alternating bilateral visual, auditory, and/or tactile stimulation (see supplement for protocol).
The number of sessions varies per patient (1-3 sessions), depending on the desensitization of the conditioned stimuli.
The sessions will last 60-90 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Degree of conditioned nausea and vomiting
Time Frame: Before intake EMDR therapy session and three weeks after last EMDR therapy session
|
Degree of conditioned nausea and vomiting after exposure to conditioned stimuli using the nausea profile questionnaire measured using the nausea profile questionnaire (9-point Likert scale, higher scores = worse outcome)
|
Before intake EMDR therapy session and three weeks after last EMDR therapy session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Impact on QoL of conditioned nausea and vomiting
Time Frame: Before EMDR therapy
|
Impact on QoL of conditioned nausea and vomiting using Functional Living Index- Emesis (FLIE) questionnaire (7-point Likert scale, higher scores = better/worse outcome, depending on the question)
|
Before EMDR therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jacco J de Haan, MD, PhD, University Medical Center Groningen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 2, 2025
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Study Registration Dates
First Submitted
December 9, 2024
First Submitted That Met QC Criteria
January 8, 2025
First Posted (Actual)
January 10, 2025
Study Record Updates
Last Update Posted (Actual)
December 11, 2025
Last Update Submitted That Met QC Criteria
December 4, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19946
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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