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

Официальное название

Managing Anorexia During Chemoradiation With Olanzapine (MACRO)

Обзор

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.

Подробное описание

PRIMARY OBJECTIVE:

I. To assess the effect of adding olanzapine to standard symptom management on preventing weight loss during chemoradiation.

SECONDARY OBJECTIVES:

I. To assess the effect of olanzapine on:

* Preventing severe weight loss; * The rate of toxicities-unrelated, possibly- or probably- related to the symptom management regimen (regardless of causality)

II, Quality of Life (QOL) scores:

* With particular attention to nausea, vomiting, appetite, loss, swallowing, pain; and Special attention to sleep; * Opiate use, hospitalization rate, feeding tube use, chemotherapy delays, and additional olanzapine prescriptions.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive standard of care symptom management on study per the discretion of the treating institution.

ARM II: Starting day 1 of CRT, patients receive olanzapine PO QD for up to 10 weeks after completion of CRT in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care symptom management on study per the discretion of the treating institution.

After completion of study treatment, patients are followed up at 5 weeks.

Вмешательства

• Другое Best Practice
  Given standard of care symptom management
• Препарат Olanzapine
  Given PO
• Другое Questionnaire Administration
  Ancillary studies

Первичные конечные точки

• Average change in weight [Срок оценки: From baseline to patient lowest weight during chemoradiation therapy (CRT) treatment, assessed up to 5 weeks after last dose of study treatment]

Вторичные конечные точки (10)

• Proportion of patients with severe weight loss [Срок оценки: At baseline up to any time point during CRT treatment, assessed up to 5 weeks after last dose of study treatment]
• Incidence of adverse events [Срок оценки: Up to 5 weeks after last dose of study treatment]
• Change in quality of life (QOL) scores [Срок оценки: Baseline up to 5 weeks after last dose of study treatment]
• Change in Quality of Life [Срок оценки: Up to 5 weeks after last dose of study treatment]
• Changes in sleep [Срок оценки: Baseline up to 5 weeks after last dose of study treatment]
• Opiate use [Срок оценки: Up to 5 weeks after last dose of study treatment]
• Hospitalization rate [Срок оценки: Up to 5 weeks after last dose of study treatment]
• Feeding tube use [Срок оценки: Up to 5 weeks after last dose of study treatment]
• Chemotherapy delays [Срок оценки: Up to 5 weeks after last dose of study treatment]
• Additional olanzapine prescriptions [Срок оценки: Up to 5 weeks after last dose of study treatment]

Критерии участия

Критерии включения

• Age ≥ 18 years old
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
• Diagnosed with biopsy-proven, squamous cell carcinoma of the head and neck, including squamous cell carcinoma of the neck with unknown primary site
• Eligible for curative-intent chemoradiation therapy of the head and neck
• Patients must be eligible for concurrent systemic therapy (preferably platinum based) as determined by the treating medical oncologist to undergo platinum-based chemotherapy
• Ability to swallow and retain oral medication
• Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
• Participants must agree to avoid the following while taking Olanzapine while they are on study:

• Taking the drug Symbyax (which already contains olanzapine)
• Consuming alcohol
• Operating hazardous machinery, including automobiles, until you are reasonably certain that the study drug therapy does not have any bad effects on your mental and physical health
• Participant must understand the investigational nature of this study and sign an institutional review board approved written informed consent form prior to receiving any study related procedure

Критерии исключения

• Eligible for palliative-intent radiation therapy only
• Patients with a feeding tube
• Regular systemic steroid use
• Atypical antipsychotic use

• Other dopamine receptor blockers routinely used as anti-emetics (eg. prochlorperazine/compazine and metoclopramide) are allowed to be prescribed as usual care on this study
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes or psychiatric illness/social situations that would limit compliance with study requirements
• Known hypersensitivity to olanzapine
• Pregnant or nursing female participants
• Known history of seizures
• Unwilling or unable to follow protocol requirements
• Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Roswell Park Cancer Institute — Buffalo

Идентификаторы

NCT: NCT06995508 · I 3757323 · NCI-2025-03335 · I 3757323

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗