Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05705492 | Suspended | Advanced Malignant Solid Neoplasm

Olanzapine for the Management of Cancer Associated Appetite Loss in Patients With Advanced and Incurable Solid Tumors
Sponsor:

OHSU Knight Cancer Institute

Information provided by (Responsible Party):

Eric Roeland, M.D., FAAHPM

Brief Summary:

This phase II trial tests how well olanzapine may work in managing cancer cachexia in patients experiencing advanced solid tumor cancer-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 used by the brain to transmit messages to the rest of the body) that may stimulate appetite, restore caloric intake, minimize weight loss, and improve quality of life.

Condition or disease

Advanced Malignant Solid Neoplasm

Intervention/treatment

Biospecimen Collection

Computed Tomography

Olanzapine

Placebo Administration

Questionnaire Administration

Phase

Phase 2

Detailed Description:

PRIMARY OBJECTIVE: I. To assess the effect of olanzapine versus placebo for decreasing cancer-associated anorexia at 2 weeks for patients with advanced cancer receiving systemic therapy. SECONDARY OBJECTIVE: I. To evaluate the longitudinal impact of olanzapine versus placebo over 6 weeks on food intake, anthropometric measures, physical function, patient-reported symptoms, quality of life, toxicity, and healthcare utilization. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive 5mg of olanzapine orally (PO) nightly for six weeks on study. Patients may also undergo an optional computed tomography (CT) scan and blood sample collection on the study. ARM II: Patients receive placebo PO nightly for six weeks and then receive 5mg of olanzapine PO nightly for 6 weeks (i.e., wait-list control). Patients may also undergo an optional CT scan and collection of blood samples on the study.}}

Study Type : Interventional
Estimated Enrollment : 44 participants
Masking : Double
Primary Purpose : Supportive Care
Official Title : ACTO: A Phase II, Randomized, Placebo-Controlled Study Evaluating Olanzapine in the Management of Cancer Cachexia
Actual Study Start Date : January 31, 2024
Estimated Primary Completion Date : November 1, 2024
Estimated Study Completion Date : November 1, 2024
Arm Intervention/treatment

Experimental: Arm I (olanzapine, optional biospecimen collection)

Patients receive olanzapine PO for six weeks on study. Patients may also undergo an optional CT scan and blood sample collection on the study.

Procedure: Biospecimen Collection

Procedure: Computed Tomography

Drug: Olanzapine

Other: Questionnaire Administration

Placebo Comparator: Arm II (placebo, olanzapine, optional biospecimen collection)

Patients receive placebo PO for six weeks and then receive olanzapine PO for 6 weeks. Patients also undergo an optional CT scan and collection of blood samples on study.

Procedure: Biospecimen Collection

Procedure: Computed Tomography

Drug: Olanzapine

Drug: Placebo Administration
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Willingness to provide written informed consent.
  • Individuals >= 18 years of age of all races, ethnicities, sexual orientations, gender identities, and abilities may be screened for enrollment without bias
  • Histologically confirmed advanced and incurable solid tumor cancer diagnosis within 12 weeks of screening. Cancer diagnoses will include those for which standard curative measures do not exist or are no longer effective
  • Planned or ongoing standard of care (SOC) systemic antineoplastic therapy without curative intent (concurrent to this study)
  • Able to ambulate independently with or without assistive devices (e.g., cane, walker).
  • In the case of brain metastases, the individual must be asymptomatic or previously treated with a full cycle of therapy such that recovery from any acute effects of radiation therapy or surgery has occurred before the screening. Such individuals must have discontinued corticosteroid treatment and be neurologically stable for at least 4 weeks before screening
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Able and willing to discontinue the use of any drug or over-the-counter (OTC) product that may interact with the study drug (within a period sufficient for wash-out per the investigator's discretion) and thereafter while on the study
  • Willingness to comply with restrictions on chest/breastfeeding
  • Individuals capable of childbearing and contributing viable sperm must be willing to comply with contraception requirements and not donate ova or sperm while on the study and for 1 month after that
  • A negative pregnancy test at baseline must be obtained for individuals capable of childbearing
Exclusion Criteria
  • Plan for, or history of (within 30 days of registration), the use of an antipsychotic drug, including, but not limited to risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone. This limitation does not include prochlorperazine and other phenothiazines as antiemetic therapy. The use of antipsychotics concurrent with protocol therapy will not be allowed
  • Previous or current use of megestrol acetate, cannabinoids (including, but not limited to dronabinol, medical cannabis, over the counter [OTC] cannabinoids products), and/or corticosteroids (defined as >= 5mg of prednisone or equivalent per day, except for standard chemotherapy-induced nausea and vomiting [CINV] prophylaxis) during the proceeding >=14 days
  • Known history of poorly controlled diabetes, defined as fasting morning blood sugars > 300 mg/dL or recent hemoglobin A1c >= 8
  • Inadequate organ function, which may include, but is not limited to, the following laboratory results within 28 days before signing consent
    • Total bilirubin > upper limit of normal (ULN), aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SPGT]) > 2.5 ULN (unless the participant has documented Gilbert's syndrome, hepatocellular carcinoma, or hepatic metastases)
    • Serum creatinine > 2.0 mg/dL or calculated glomerular filtration rate (GFR) >= 30 mL/minute/1.73 m^2 as calculated by the modification of diet in renal disease (MDRD) equation
    • NOTE: Investigator discretion will determine continued eligibility after randomization occurs in the event the liver function test results are greater than (>) the proposed upper limit of normal
    • Tube feeding or parenteral nutrition at the time of screening
    • Any condition that may negatively impact oral absorption of the study drug (including, but not limited to dysphagia, mucositis, gastrectomy, colitis, bowel obstruction, high output ileostomy) or any plan to undergo an intervention that will render such a condition
    • Recurrent ascites unresponsive to medical interventions and requires therapeutic paracentesis
    • Uncontrolled symptoms (including, but not limited to, pain and nausea) at randomization make the individual unsuitable for the study in the judgment of the principal investigator (PI). If uncontrolled symptoms can be effectively palliated for >= 1 week prior, enrollment may be considered at the discretion of the PI
    • Uncontrolled infection, including coronavirus disease 2019 (COVID-19), at time of randomization. Individuals with the uncontrolled infection will not be eligible as the symptomology of infection may obscure the outcomes of this study
    • Other medical or psychiatric condition, including recent (within 1 year) or active suicidal ideation/behavior or laboratory abnormality, may increase the risk of study participation or, in the investigator's judgment, makes the participant inappropriate for the study
Olanzapine for the Management of Cancer Associated Appetite Loss in Patients With Advanced and Incurable Solid Tumors

Location Details

Please Choose a site

Olanzapine for the Management of Cancer Associated Appetite Loss in Patients With Advanced and Incurable Solid Tumors

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Oregon

OHSU Knight Cancer Institute

Portland, Oregon, United States, 97239