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NCT06995508 · ClinicalTrials.gov registry record · Phase 2
Olanzapine for Managing Anorexia in Head and Neck Cancer Patients Undergoing Chemoradiation, MACRO Trial
A Phase 2 study of Head and Neck Squamous Cell Carcinoma and Neck Squamous Cell Carcinoma of Unknown Primary, sponsored by Roswell Park Cancer Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
- 1
- Study location
NCT06995508 is a Phase 2 study of Head and Neck Squamous Cell Carcinoma and Neck Squamous Cell Carcinoma of Unknown Primary that is actively recruiting participants, run by Roswell Park Cancer Institute. The registered enrollment target is 66 participants, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (44% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06995508, a Phase 2 study of Head and Neck Squamous Cell Carcinoma and Neck Squamous Cell Carcinoma of Unknown Primary, is actively recruiting participants, sponsored by Roswell Park Cancer Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial compares the effect of adding olanzapine to standard of care symptom management for nausea to standard of care alone in managing an abnormal loss of the appetite for food (anorexia) in patients treated with chemoradiation therapy (CRT) for head and neck cancer. Patients undergoing CRT may experience treatment-related side effects, including pain, nausea, and a discomfort in the ability to speak, swallow and eat. These side effects have been shown to increase weight loss, opiate use and hospitalization. Olanzapine is a drug used to treat certain mental disorders. It is also being studied in the treatment of nausea and vomiting caused by some cancer treatments. It is a type of anti-psychotic and a type of monoamine antagonist. Adding olanzapine to standard of care symptom management to limit nausea may be more effective than standard of care alone in managing anorexia in head and neck cancer patients during CRT.
Conditions Studied
Interventions
- OTHER Questionnaire Administration
- OTHER Best Practice
- DRUG Olanzapine
Study Locations (1)
New York
- Roswell Park Cancer Institute - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2025-12-24 |
| Est. Completion | 2031-11-15 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06995508
The ClinicalTrials.gov registry entry for NCT06995508 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (44% lower). The listed sponsor is Roswell Park Cancer Institute, which has 365 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Questionnaire Administration is the first listed.
NCT06995508 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT06995508 about?
NCT06995508 is a clinical study titled "Olanzapine for Managing Anorexia in Head and Neck Cancer Patients Undergoing Chemoradiation, MACRO Trial". This phase II trial compares the effect of adding olanzapine to standard of care symptom management for nausea to standard of care alone in managing an abnormal loss of the appetite for food (anorexia) in patients treated with chemoradiation therapy (CRT) for head and neck cancer. Patients undergoin...
What is the current status of trial NCT06995508?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2025-12-24. Estimated completion is 2031-11-15.
What conditions does trial NCT06995508 study?
This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma, Neck Squamous Cell Carcinoma of Unknown Primary, Cancer-Associated Anorexia.
What interventions are being tested in trial NCT06995508?
The interventions under investigation include: Questionnaire Administration (OTHER), Best Practice (OTHER), Olanzapine (DRUG).
Who is sponsoring clinical trial NCT06995508?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06995508 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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