Olanzapine for Appetite Loss in Cancer
Palo Alto (17 mi)Overseen byEric Roeland, M.D., FAAHPM, FASCO
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: OHSU Knight Cancer Institute
Prior Safety Data
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This phase II trial tests how well olanzapine works in managing cancer cachexia in patients experiencing esophagogastric (EG), hepatopancreaticobiliary (HPB) or lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic) -associated appetite loss while receiving non-curative cancer therapy. Loss of appetite ("anorexia") in the setting of cancer is a key feature of "cachexia," a syndrome associated with loss of weight and muscle as well as weakness and fatigue. Olanzapine is a type of drug that targets key neurotransmitters (a type of molecule that is used by the central nervous system to transmit messages to the rest of the body) that may stimulate appetite, restore caloric intake, minimize weight loss, and improve quality of life.
What safety data exists for olanzapine in treating appetite loss in cancer patients?Olanzapine has been studied for its efficacy in managing symptoms like nausea, vomiting, and anorexia in cancer patients. In several studies, it has shown potential benefits without significant adverse effects. For instance, in a study with five cancer patients, no adverse effects were observed. Another retrospective review of 41 patients also reported no treatment-related adverse events. These findings suggest that olanzapine is generally well-tolerated in cancer patients for symptom management, including appetite loss.15678
Is the drug Olanzapine a promising treatment for appetite loss in cancer?Yes, Olanzapine is a promising treatment for appetite loss in cancer. It has been shown to help improve appetite and manage symptoms like nausea and vomiting in cancer patients, which can lead to better weight gain and quality of life.13478
What data supports the idea that Olanzapine for Appetite Loss in Cancer is an effective drug?The available research shows that Olanzapine can help improve appetite and weight gain in cancer patients undergoing chemotherapy. In one study, it was found to be effective in stimulating appetite in patients with advanced cancers like gastric, liver, and lung cancer. Another study reported that Olanzapine not only helped control vomiting but also improved appetite in some cancer patients. These findings suggest that Olanzapine can be a useful option for managing appetite loss in cancer patients.12578
Do I have to stop taking my current medications for the trial?The trial requires you to stop using any drugs or over-the-counter products that may interact with the study drug. The specific washout period will be determined by the investigator. Additionally, you cannot use certain medications or supplements aimed at enhancing appetite within 14 days before the trial.
Eligibility Criteria
This trial is for adults with advanced, incurable solid tumors like gastric, liver or lung cancer who are experiencing appetite loss. They must be undergoing non-curative cancer therapy and have an ECOG performance status of 0-2. Participants should not be pregnant, must agree to use contraception, and cannot have certain medical conditions or be on conflicting medications.Treatment Details
The trial is testing if olanzapine can help manage appetite loss in patients with advanced cancers. It involves comparing the effects of olanzapine against a placebo while also collecting biospecimens and using questionnaires to assess quality of life.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm IIExperimental Treatment2 Interventions
Patients receive a higher dose (5 mg) of olanzapine PO nightly for 12 weeks in the absence of unacceptable toxicity. Patients may choose to enroll in an additional 12 weeks of treatment. Patients undergo an optional baseline CT scan and collections of monthly blood samples on study.
Group II: Arm I (olanzapine, optional biospecimen collection)Experimental Treatment2 Interventions
Patients receive a lower (2.5mg) dose of olanzapine orally (PO) nightly for 12 weeks in the absence of unacceptable toxicity. Patients may choose to enroll in an additional 12 weeks of treatment. Patients can choose to undergo computed tomography (CT) scan at baseline and monthly blood sample collections on study.
Group III: Arm IIIPlacebo Group2 Interventions
ARM III: Patients receive placebo PO nightly for 12 weeks in the absence of unacceptable toxicity. Patients may choose to enroll in an additional 12 weeks of treatment. Patients undergo CT scan and monthly collection of blood samples on study.
Find a clinic near you
Research locations nearbySelect from list below to view details:
OHSU Knight Cancer InstitutePortland, OR
Loading ...
Who is running the clinical trial?
OHSU Knight Cancer InstituteLead Sponsor
National Cancer Institute (NCI)Collaborator
Oregon Health and Science UniversityCollaborator
References
[Olanzapine use in cancer patients for refractory vomiting]. [2019]Recent investigations suggest the efficacy of olanzapine in cancer patients with intractable vomiting or chemotherapy-induced nausea. Olanzapine,indicated for schizophrenia in Japan, has an affinity for multiple neurotransmitter receptors including dopaminergic, serotonergic, histaminergic, adrenergic and muscarinic receptors. This pharmacological activity thus has a potential role in the treatment of nausea and vomiting. In the present study, olanzapine was given to five cancer patients with refractory vomiting to standard medications. In 3 cases, olanzapine resolved vomiting completely and also improved anorexia, In 2 cases, vomiting was controlled for a limited period. No adverse effect was observed. These results suggest olanzapine is a useful agent for the management of both vomiting and anorexia.
Effectiveness of olanzapine for the treatment of breakthrough chemotherapy induced nausea and vomiting. [2018]To evaluate safety and efficacy of olanzapine for breakthrough emesis in addition to standard antiemetic regimen in cancer patients receiving highly emetogenic chemotherapy.
Olanzapine for the prevention and treatment of cancer-related nausea and vomiting in adults. [2022]Olanzapine as an antiemetic represents a new use of an antipsychotic drug. People with cancer may experience nausea and vomiting whilst receiving chemotherapy or radiotherapy, or whilst in the palliative phase of illness.
Resurgence of Eating Disorders with Olanzapine. [2020]Olanzapine is commonly utilized in palliative care for the treatment of nausea, and a known side effect of olanzapine is increased appetite. Olanzapine is also known to cause re-emergence of eating disorders (EDs) in patients utilizing olanzapine for its antipsychotic effects. It is unclear to what extent this may also occur in patients with serious/life-limiting illness.
Supportive care for the prevention of nausea, vomiting and anorexia in a phase 1B study of selinexor in advanced cancer patients: an exploratory study. [2022]Clinical observations of cancer patients treated with selinexor have reported high incidence of nausea and anorexia. The study objective was to investigate the adoption of prophylactic olanzapine for the prevention of nausea, vomiting and anorexia in cancer patients receiving selinexor and standard chemotherapy.
Efficacy of Olanzapine for Symptom Relief in Cancer Patients. [2023]Olanzapine is an atypical antipsychotic and is widely used for prophylaxis of chemotherapy-induced nausea and vomiting in cancer patients. Previous studies have suggested its potential efficacy for the relief of various symptoms in cancer patients, especially gastrointestinal and psychiatric symptoms. We retrospectively reviewed the prescription of olanzapine to cancer patients at our hospital. Between 2008 and 2020, olanzapine was prescribed to 41 patients for relief of symptoms associated with cancer other than prophylaxis of chemotherapy-induced nausea and vomiting. Of those patients, symptom relief was seen in 53.7%. Notably, olanzapine was effective in 13 of 14 patients with chemotherapy-induced nausea and vomiting refractory to guideline-recommended prophylaxis. Of 16 patients in whom this symptom was not relieved by olanzapine, 13 (81.3%) continued taking olanzapine even after it was judged ineffective. No treatment-related adverse events were seen in this study. Our observation implies good efficacy of olanzapine for refractory chemotherapy-induced nausea and vomiting and a tendency to continue olanzapine even in those for whom it was ineffective.
Randomized Double-Blind Placebo-Controlled Study of Olanzapine for Chemotherapy-Related Anorexia in Patients With Locally Advanced or Metastatic Gastric, Hepatopancreaticobiliary, and Lung Cancer. [2023]Anorexia occurs in 30%-80% of patients with advanced malignancies, which may be worsened with chemotherapy. This trial assessed the efficacy of olanzapine in stimulating appetite and improving weight gain in patients receiving chemotherapy.
Benefits and risks of off-label olanzapine use for symptom management in cancer patients-a case report. [2023]Cancer patients often experience symptoms such as anorexia, anxiety and insomnia, which can impact their quality of life. Randomized placebo-controlled trials support prophylactic use of olanzapine for the prevention of nausea and vomiting due to moderate and high-emetic risk chemotherapy. In the setting of palliative care, olanzapine is increasingly utilized as an off-label treatment of symptoms including anorexia-cachexia, anxiety, and insomnia. The following case reports will highlight the potential benefits and risks of off-label olanzapine use for symptom management in cancer patients.