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Olanzapine for Managing Anorexia in Head and Neck Cancer Patients Undergoing Chemoradiation, MACRO Trial

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv7
  2. Eligibility criteria expanded, about 1 word
    • Study description shortened, about 2 words
    v6
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 15, 2026 to Dec 24, 2025
    • Site details revised
    v5
  4. Start date: Nov 15, 2025 to Jan 15, 2026v4
  5. Start date: Sep 13, 2025 to Nov 15, 2025
    • Primary completion date: Jun 13, 2030 to Nov 15, 2030
    • Study completion date: Jun 13, 2031 to Nov 15, 2031
    v3
  6. Start date: Jun 13, 2025 to Sep 13, 2025v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06995508
Lead Sponsor Roswell Park Cancer Institute
Conditions
(from sponsor)		 Cancer-Associated Anorexia, Head and Neck Squamous Cell Carcinoma, Neck Squamous Cell Carcinoma of Unknown Primary
Related terms Squamous Cell Carcinoma of Head and Neck
Enrollment 66 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov