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

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ClinicalTrials.gov Identifier: NCT05705492
Recruitment Status : Recruiting
First Posted : January 30, 2023
Last Update Posted : May 2, 2024
Sponsor:
Collaborators:
Oregon Health and Science University
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eric Roeland, M.D., FAAHPM, FASCO, OHSU Knight Cancer Institute

Study Description
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Brief Summary:
This phase II trial tests how well olanzapine may work in managing cancer cachexia in patients living with gastric, hepatopancreaticobiliary 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) 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 (QOL).

Condition or disease Intervention/treatment Phase
Advanced Malignant Solid Neoplasm Procedure: Biospecimen Collection Procedure: Computed Tomography Drug: Olanzapine Drug: Placebo Administration Other: Questionnaire Administration Phase 2

Detailed Description:

PRIMARY OBJECTIVE:

I. To assess the impact of olanzapine 2.5 mg verses placebo on the proportion of patients with locally advanced or metastatic cancers receiving first-line systemic therapy with > 5% weight gain over 12 weeks. (Part A)

SECONDARY OBJECTIVE:

I. To evaluate the impact of olanzapine 2.5 mg and placebo versus (vs) olanzapine 5 mg on the proportion of patients with > 5% weight gain over 12 weeks. (Part A)

II. To evaluate the impact of olanzapine 2.5 mg vs olanzapine 5 mg vs placebo on additional cancer cachexia-associated endpoints over 12 weeks (anorexia, nutritional status, physical function, patient-reported symptoms and QOL, safety and toxicity, and healthcare utilization) over 12 weeks. (Part A)

OUTLINE:

PART A: Patients are randomized to 1 of 3 arms. All three arms have an optional baseline computed tomography (CT) scan (timed with standard-of-care imaging) at baseline and monthly blood sample collections.

ARM I: Patients receive a lower (2.5 mg) 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 (PART B).

ARM II: Patients receive a higher (5 mg)dose 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 CT scan and collection of blood samples on study.

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 collection of blood samples on study.

PART B: All patients receive a lower (2.5mg) dose of olanzapine PO nightly for 12 additional weeks in the absence of unacceptable toxicity. Patients may choose to participate in additional blood sample collections.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: ACTO: A Phase II, Randomized, Placebo-Controlled Study Evaluating Olanzapine in the Management of Cancer Cachexia
Estimated Study Start Date : May 1, 2024
Estimated Primary Completion Date : June 1, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I (olanzapine, optional biospecimen collection)
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.
 Procedure: Biospecimen Collection
Undergo blood specimen collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection

Procedure: Computed Tomography
Undergo a CT scan
Other Names:
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT Scan
  • tomography

Drug: Olanzapine
Given PO
Other Names:
  • LY 170053
  • Zyprexa
  • Zyprexa Zydis

Other: Questionnaire Administration
Ancillary studies
Experimental: Arm II
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.
 Procedure: Biospecimen Collection
Undergo blood specimen collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection

Procedure: Computed Tomography
Undergo a CT scan
Other Names:
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT Scan
  • tomography

Drug: Olanzapine
Given PO
Other Names:
  • LY 170053
  • Zyprexa
  • Zyprexa Zydis

Other: Questionnaire Administration
Ancillary studies
Placebo Comparator: Arm III
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.
 Procedure: Biospecimen Collection
Undergo blood specimen collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection

Procedure: Computed Tomography
Undergo a CT scan
Other Names:
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT Scan
  • tomography

Drug: Placebo Administration
Given PO

Other: Questionnaire Administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. Change in weight [ Time Frame: Baseline to 12 weeks from baseline ]
    >5% weight gain comparing olanzapine 2.5mg (Arm 1) vs. placebo (Arm 3)


Secondary Outcome Measures :
  1. >5% weight gain comparing olanzapine 2.5mg vs. olanzapine 5mg vs. placebo [ Time Frame: At baseline, 12 weeks from baseline ]
    Weight

  2. Patient-reported anorexia comparing olanzapine 2.5mg vs. olanzapine 5mg vs. placebo [ Time Frame: At baseline and 4, 8, 12 and 12 weeks from baseline ]
    Functional Assessment of Anorexia-Cachexia Therapy (FAACT) ≥37 Visual analog scale

  3. Nutrition [ Time Frame: At baseline and 12 weeks from baseline ]
    Patient-Generated Subjective Global Assessment Short Form (PG-SGA-SF)

  4. Physical function: performance status [ Time Frame: At baseline, 4, 8, and 12 weeks from baseline ]
    Eastern Cooperative Oncology Group (ECOG) performance status

  5. Patient-reported quality of life [ Time Frame: At baseline and at 4, 8, and12 weeks from baseline ]
    Functional Assessment of Cancer Therapy - General (FACT-G)

  6. Patient-reported symptoms and quality of life [ Time Frame: At 2, 4, and 6 weeks from baseline ]
    Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

  7. Incidence of adverse events [ Time Frame: At baseline, 4, 8, and 12 weeks from baseline ]
    National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.

  8. Health Care Utilization [ Time Frame: At 4, 8, and 12 weeks from baseline ]
    Emergency department visits and unplanned hospitalizations

  9. CT scan (optional) [ Time Frame: At baseline, if available per standard of care ]
    Body composition analysis

  10. Serum Biomarkers (optional) [ Time Frame: At baseline and at 4, 8, and 12 weeks from baseline ]
    C-reactive protein (CRP), interleukin-6 (IL-6), lpocalin-2 (LCN2), growth differentiation factor 15 (GDF-15)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 locally advanced or metastatic gastric, hepatopancreaticobiliary (HPB), and lung cancers 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), first-line systemic antineoplastic therapy without curative intent (concurrent to this study)
  • Able to ambulate independently with or without assistive devices (e.g., cane, walker).
  • 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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05705492


Locations
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United States, Oregon
OHSU Knight Cancer Institute Recruiting
Portland, Oregon, United States, 97239
Contact: Eric Roeland, M.D., FAAHPM, FASCO    503-494-8534    roeland@ohsu.edu   
Principal Investigator: Eric Roeland, M.D., FAAHPM, FASCO         
Sponsors and Collaborators
OHSU Knight Cancer Institute
Oregon Health and Science University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Eric Roeland, M.D., FAAHPM, FASCO OHSU Knight Cancer Institute
More Information
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Responsible Party: Eric Roeland, M.D., FAAHPM, FASCO, Principal Investigator, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT05705492    
Other Study ID Numbers: STUDY00024724
NCI-2022-10209 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
STUDY00024724 ( Other Identifier: OHSU Knight Cancer Institute )
P30CA069533 ( U.S. NIH Grant/Contract )
First Posted: January 30, 2023    Key Record Dates
Last Update Posted: May 2, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eric Roeland, M.D., FAAHPM, FASCO, OHSU Knight Cancer Institute:
cancer
cachexia
weight loss
loss of appetite
Additional relevant MeSH terms:
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Cachexia
Weight Loss
Body Weight Changes
Body Weight
Thinness
Olanzapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
 Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Selective Serotonin Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents