NCT06769165

Brief Summary

To explore the effectiveness of EMDR therapy treatment in reducing symptoms of chemotherapy-induced conditioned nausea and vomiting in (former) patients with cancer.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress78%
Jul 2025Aug 2026

First Submitted

Initial submission to the registry

December 9, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 10, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

July 2, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

December 11, 2025

Status Verified

December 1, 2025

Enrollment Period

1.1 years

First QC Date

December 9, 2024

Last Update Submit

December 4, 2025

Conditions

Keywords

EMDRNauseaVomiting

Outcome Measures

Primary Outcomes (1)

  • Degree of conditioned nausea and vomiting

    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 Outcomes (1)

  • Impact on QoL of conditioned nausea and vomiting

    Before EMDR therapy

Study Arms (1)

EMDR Therapy

EXPERIMENTAL

EMDR therapy sessions with a trained psychologist.

Other: EMDR therapy

Interventions

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.

EMDR Therapy

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years or older

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9713 GZ, Netherlands

RECRUITING

MeSH Terms

Conditions

NauseaVomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jacco J de Haan, MD, PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacco J de Haan, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2024

First Posted

January 10, 2025

Study Start

July 2, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

December 11, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations