What side effects are associated with this type of intervention?

Common treatments for blood cancers, such as chemotherapy and targeted therapies, often result in side effects like fatigue, nausea, anemia, and infections. Specific treatments like Olanzapine, used for appetite stimulation in advanced cancer patients, may also cause side effects such as weight gain, drowsiness, and metabolic changes. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

FDA-approved treatments for blood cancers include a variety of chemotherapeutic agents, targeted therapies, and immunotherapies. For example, romiplostim and eltrombopag are approved for managing thrombocytopenia in patients with conditions like myelodysplastic syndromes and chemotherapy-induced thrombocytopenia. These treatments help improve platelet counts, allowing patients to continue their chemotherapy regimens. While these drugs are not directly related to appetite stimulation like Olanzapine, they play a crucial role in the supportive care of blood cancer patients by managing hematologic complications.

What other types of research exist?

Megestrol acetate is a well-established alternative for appetite stimulation in cancer patients. Additionally, cannabis extract and delta-9-tetrahydrocannabinol (THC) have shown promise in treating cancer-related anorexia-cachexia syndrome. Nabilone, a synthetic cannabinoid, has also demonstrated positive effects on appetite and nutritional status in cancer patients.

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Antipsychotic

Olanzapine vs Megestrol Acetate for Cancer-Related Anorexia

Phase 3

Recruiting

Research Sponsored by Alliance for Clinical Trials in Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done =< 14 days prior to registration is required

No symptomatic leptomeningeal disease or known brain metastases as these patients may have difficulty taking oral medications

Must not have

Patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study

Patients who cannot swallow oral formulations of the agents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 4 weeks

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial tests whether olanzapine or megestrol acetate is better at increasing appetite in patients with advanced cancer. These patients often struggle with eating and weight loss. Both medications aim to make them feel hungrier, helping them eat more and gain weight. Megestrol acetate is known for its effectiveness in increasing appetite in patients with cancer.

Who is the study for?

Adults with advanced cancer experiencing loss of appetite or weight loss, who haven't used olanzapine for other conditions or certain appetite stimulants recently. Participants must not have severe diabetes, heart failure, hypertension, a history of blood clots, brain metastases causing symptoms, digestive obstructions or persistent vomiting. They should be able to swallow pills and not have infections like HIV that could complicate the trial.

What is being tested?

This phase III trial is testing whether olanzapine is more effective than megestrol acetate in increasing appetite and preventing weight loss in patients with advanced cancer. Patients will either receive olanzapine or megestrol acetate and their appetites will be monitored through questionnaires.

What are the potential side effects?

Olanzapine may cause drowsiness, increased appetite leading to weight gain, dry mouth, constipation, restlessness and potential metabolic changes. Megestrol acetate can lead to increased fat accumulation at various body sites (lipodystrophy), blood clots risk increase (thromboembolic phenomena), fluid retention and possible effects on hormone levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not pregnant or nursing and, if capable of becoming pregnant, I have a recent negative pregnancy test.

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I do not have brain metastases or leptomeningeal disease.

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I am not currently taking olanzapine for any condition.

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My blood pressure and heart failure are well-managed.

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I am 18 years old or older.

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I have never had a blood clot.

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My diabetes is well-managed.

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My cancer is in an advanced stage.

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I have lost at least 5 pounds in the last 2 months or eat less than 20 calories/kg of body weight daily.

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I can take care of myself and am up and about more than half of my waking hours.

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I do not have blockages in my digestive tract, issues absorbing food, or severe vomiting.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am capable of making my own health decisions.

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I cannot swallow pills.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in appetite

Secondary study objectives

Change in well-being status and cachexia/anorexia symptoms

Proportion of patients who report a 5% or greater weight gain

Side effects data

From 2008 Phase 4 trial • 25 Patients • NCT00001656

70%

tachycardia >100 beats/min (supine)

67%

Hypersalivation

64%

Hypertension

42%

Enuresis

33%

Increased appetite

33%

Difficulty concentrating

25%

Insomnia

17%

Abnormal white blood count

17%

Somnolence

17%

Constipation

10%

Tachycardia >120 beats/min (supine)

100%

80%

60%

40%

20%

Study treatment Arm

Clozapine Group

Olanzapine Group

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (olanzapine)Experimental Treatment2 Interventions

Patients receive olanzapine PO QD for up to 4 weeks in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (megestrol acetate)Active Control2 Interventions

Patients receive megestrol acetate PO QD for up to 4 weeks in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Olanzapine

2005

Completed Phase 4

~5480

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for blood cancers, such as chemotherapy, targeted therapy, and immunotherapy, work through various mechanisms to eliminate cancer cells. Chemotherapy uses cytotoxic agents to kill rapidly dividing cells, including cancer cells. Targeted therapies, like tyrosine kinase inhibitors, block specific molecules involved in cancer cell growth and survival. Immunotherapy harnesses the body's immune system to recognize and destroy cancer cells. These treatments are crucial for blood cancer patients as they directly target the malignancy, aiming to achieve remission or cure. Additionally, supportive care treatments, such as olanzapine for appetite stimulation, are essential to manage symptoms and improve the quality of life during treatment.

Stress Granules in the Anti-Cancer Medications Mechanism of Action: A Systematic Scoping Review.