Olanzapine for the Management of Cancer Associated Appetite Loss in Patients With Advanced Esopha… (NCT05705492) | Clinical Trial Compass
RecruitingPhase 2
Olanzapine for the Management of Cancer Associated Appetite Loss in Patients With Advanced Esophagogastric, Hepatopancreaticobiliary, Colorectal or Lung Cancer
United States66 participantsStarted 2024-07-17
Plain-language summary
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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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 suffic…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing olanzapine, which is an antipsychotic medication, to help with cancer-related appetite loss and weight gain — can you explain why an antipsychotic drug is being used for this purpose, and what that means for the kinds of side effects I might experience?
2Since this is a Phase 2 trial, the researchers are still figuring out how well olanzapine works for appetite loss in my type of cancer — does that mean there's less certainty about whether it will actually help me compared to options that are already standard of care?
3The trial is measuring whether patients gain more than 5% of their body weight — given where I am in my treatment right now, is that a realistic and meaningful goal for my situation, or would my doctor recommend a different approach to managing my appetite and weight loss first?
4My cancer type is listed as one of the eligible conditions, but can you help me understand whether my specific stage, current treatment plan, or other health factors might affect whether this trial would be a good fit to even discuss further with the research team?
5If I were to join this trial, what would the day-to-day or visit demands look like, and how might taking olanzapine on top of my current cancer treatment affect my quality of life during that time?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients exhibiting weight gain greater 5%