RECRUITING

Olanzapine for the Management of Cancer Associated Appetite Loss in Patients With Advanced Esophagogastric, Hepatopancreaticobiliary, Colorectal or Lung Cancer

Conditions

Advanced Malignant Solid Neoplasm Advanced Biliary Tract Carcinoma Advanced Esophageal Carcinoma Metastatic Esophageal Carcinoma Locally Advanced Biliary Tract Carcinoma Locally Advanced Colorectal Carcinoma Locally Advanced Esophageal Carcinoma Locally Advanced Gastric Carcinoma cancer cachexia weight loss loss of appetite

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II trial tests how well olanzapine works in managing cancer cachexia in patients experiencing esophagogastric, hepatopancreaticobiliary, colorectal, 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 drug that targets key neurotransmitters (a type of molecule in the central nervous system that transmits messages to the rest of the body) that may stimulate appetite, restore caloric intake, minimize weight loss, and improve quality of life (QOL).

Official Title

ACTO: A Phase II, Randomized, Placebo-Controlled Study Evaluating Olanzapine in the Management of Cancer Cachexia

Quick Facts

Study Start:2024-07-17

Study Completion:2026-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05705492

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Willingness to provide written informed consent * Individuals \>= 18 years of age * Histologically confirmed advanced local or metastatic esophogastric, hepatopancreaticobiliary, colorectal, or lung cancer diagnosis within 12 weeks of screening * Patients with weight loss as defined by international consensus criteria (documented or patient-reported): * \> 5% weight loss over the past 6 months * \> 2% weight loss with body mass index (BMI) \<20 kg/m\^2 or sarcopenia * Planned or ongoing first-line palliative antineoplastic therapy (cytotoxic chemotherapy, targeted therapy, immunotherapy, combinations) with or without radiation therapy and have not started the second cycle of first-line palliative antineoplastic therapy. Patients may have received adjuvant antineoplastic therapy at least 6 months prior to screening * 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 with recovery from any acute effects of radiation therapy or surgery before 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 principal investigators \[PI's\] 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 (BL) must be obtained for individuals capable of childbearing	* Plan for, or history of (within 30 days of enrollment), 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 * Current use of medications or supplements with the goal of enhancing appetite within ≥14 days, including: * megestrol acetate * cannabinoids (including, but not limited to dronabinol, medical cannabis, over the counter \[OTC\] cannabinoid products), and/or * Corticosteroids (defined as ≥ 5mg of prednisone \[or equivalent per day\]), except for standard-of-care chemotherapy-induced nausea and vomiting prophylaxis * Known history of poorly controlled diabetes, defined as fasting morning blood sugars ≥300 mg/dL or recent hemoglobin A1≥ 8. Individuals with diabetes will undergo hemoglobin A1c (HbA1c) blood testing if they do not have HbA1c results 12 weeks prior to enrollment * Inadequate organ function, which may include, but is not limited to, the following laboratory results within 28 days before signing consent: * Total bilirubin ≥5x upper limit of normal (ULN), aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SPGT\]) ≥5 ULN (unless the participant has documented Gilbert's syndrome, hepatocellular carcinoma, or hepatic metastases) * Primary investigator (PI) discretion will determine continued eligibility after randomization occurs in the event the liver function test results are above the proposed ULN * Renal disease requiring dialysis 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 * 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 at randomization make the individual unsuitable for the study in the judgment of the 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 PI's judgment, makes the participant inappropriate for the study

Inclusion Criteria

Exclusion Criteria

* Willingness to provide written informed consent
* Individuals \>= 18 years of age
* Histologically confirmed advanced local or metastatic esophogastric, hepatopancreaticobiliary, colorectal, or lung cancer diagnosis within 12 weeks of screening
* Patients with weight loss as defined by international consensus criteria (documented or patient-reported):
* \> 5% weight loss over the past 6 months
* \> 2% weight loss with body mass index (BMI) \<20 kg/m\^2 or sarcopenia
* Planned or ongoing first-line palliative antineoplastic therapy (cytotoxic chemotherapy, targeted therapy, immunotherapy, combinations) with or without radiation therapy and have not started the second cycle of first-line palliative antineoplastic therapy. Patients may have received adjuvant antineoplastic therapy at least 6 months prior to screening
* 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 with recovery from any acute effects of radiation therapy or surgery before 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 principal investigators \[PI's\] 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 (BL) must be obtained for individuals capable of childbearing

* Plan for, or history of (within 30 days of enrollment), 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
* Current use of medications or supplements with the goal of enhancing appetite within ≥14 days, including:
* megestrol acetate
* cannabinoids (including, but not limited to dronabinol, medical cannabis, over the counter \[OTC\] cannabinoid products), and/or
* Corticosteroids (defined as ≥ 5mg of prednisone \[or equivalent per day\]), except for standard-of-care chemotherapy-induced nausea and vomiting prophylaxis
* Known history of poorly controlled diabetes, defined as fasting morning blood sugars ≥300 mg/dL or recent hemoglobin A1≥ 8. Individuals with diabetes will undergo hemoglobin A1c (HbA1c) blood testing if they do not have HbA1c results 12 weeks prior to enrollment
* Inadequate organ function, which may include, but is not limited to, the following laboratory results within 28 days before signing consent:
* Total bilirubin ≥5x upper limit of normal (ULN), aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SPGT\]) ≥5 ULN (unless the participant has documented Gilbert's syndrome, hepatocellular carcinoma, or hepatic metastases)
* Primary investigator (PI) discretion will determine continued eligibility after randomization occurs in the event the liver function test results are above the proposed ULN
* Renal disease requiring dialysis 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
* 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 at randomization make the individual unsuitable for the study in the judgment of the 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 PI's judgment, makes the participant inappropriate for the study

Contacts and Locations

Principal Investigator

Eric Roeland, M.D., FAAHPM, FASCO

PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Study Locations (Sites)

OHSU Knight Cancer Institute

Portland, Oregon, 97239

United States

Collaborators and Investigators

Sponsor: OHSU Knight Cancer Institute

Eric Roeland, M.D., FAAHPM, FASCO, PRINCIPAL_INVESTIGATOR, OHSU Knight Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-17

Study Completion Date2026-01-01

Study Record Updates

Study Start Date2024-07-17

Study Completion Date2026-01-01

Terms related to this study

Keywords Provided by Researchers

cancer
cachexia
weight loss
loss of appetite

Additional Relevant MeSH Terms

Advanced Malignant Solid Neoplasm
Advanced Biliary Tract Carcinoma
Advanced Esophageal Carcinoma
Metastatic Esophageal Carcinoma
Locally Advanced Biliary Tract Carcinoma
Locally Advanced Colorectal Carcinoma
Locally Advanced Esophageal Carcinoma
Locally Advanced Gastric Carcinoma