Olanzapine vs Megestrol Acetate for Cancer-Related Anorexia
Recruiting in Palo Alto (17 mi)
+263 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Alliance for Clinical Trials in Oncology
Must not be taking: Antipsychotics, Appetite stimulants
Disqualifiers: Uncontrolled infection, Diabetes, Cardiac disease, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot use certain medications like systemic adrenal steroids, androgens, progesterone analogs, or other appetite stimulants within the past month. You also cannot be on other antipsychotic medications like risperidone or quetiapine within 30 days of enrollment.
What data supports the effectiveness of the drugs olanzapine and megestrol acetate for cancer-related anorexia?
Research shows that megestrol acetate can improve appetite and lead to weight gain in patients with cancer-related anorexia. Additionally, olanzapine has been found to stimulate appetite and improve weight gain in patients undergoing chemotherapy.
12345Is the combination of Olanzapine and Megestrol Acetate safe for treating cancer-related anorexia?
Megestrol Acetate is generally well-tolerated but has a clear risk of blood clots, especially at higher doses. Olanzapine is not specifically mentioned in the safety data provided, but it is commonly used for other conditions and generally considered safe with known side effects like weight gain and drowsiness.
23567How does the drug olanzapine differ from other treatments for cancer-related anorexia?
Olanzapine is unique in treating cancer-related anorexia because it is primarily an antipsychotic medication, which may help improve appetite by affecting brain chemicals differently than traditional treatments like megestrol acetate, a hormone derivative. This novel approach could offer an alternative for patients who do not respond well to existing options.
23578Eligibility Criteria
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.Inclusion Criteria
I can speak and/or read English or Spanish.
I am not pregnant or nursing and, if capable of becoming pregnant, I have a recent negative pregnancy test.
I do not have brain metastases or leptomeningeal disease.
+22 more
Exclusion Criteria
I am capable of making my own health decisions.
Psychiatric illness which would prevent the patient from giving informed consent
Medical condition such as uncontrolled infection (including human immunodeficiency virus [HIV]), uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either olanzapine or megestrol acetate orally once daily for up to 4 weeks
4 weeks
Weekly assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
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.
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.
Olanzapine is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Zyprexa for:
- Schizophrenia
- Bipolar disorder
- Depression
- Nausea and vomiting associated with chemotherapy
- Off-label use for cancer cachexia and anorexia
🇪🇺 Approved in European Union as Zyprexa for:
- Schizophrenia
- Bipolar disorder
- Depression
- Nausea and vomiting associated with chemotherapy
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Kapiolani Medical Center for Women and ChildrenHonolulu, HI
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusYpsilanti, MI
Essentia Health - Deer River ClinicDeer River, MN
Carle Cancer CenterUrbana, IL
More Trial Locations
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Who Is Running the Clinical Trial?
Alliance for Clinical Trials in OncologyLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Randomized Double-Blind Placebo-Controlled Study of Olanzapine for Chemotherapy-Related Anorexia in Patients With Locally Advanced or Metastatic Gastric, Hepatopancreaticobiliary, and Lung Cancer. [2023]Anorexia occurs in 30%-80% of patients with advanced malignancies, which may be worsened with chemotherapy. This trial assessed the efficacy of olanzapine in stimulating appetite and improving weight gain in patients receiving chemotherapy.
Treatment of cancer-related anorexia with olanzapine and megestrol acetate: a randomized trial. [2022]The purpose of the study was to determine the effectiveness of megestrol acetate (MA) and olanzapine (OLN) for the treatment of cancer-related anorexia (CRA).
High-dose megestrol acetate. A possible treatment for cachexia. [2016]Weight loss and anorexia are significant complications of a variety of disorders and add morbidity to the underlying process. We observed marked weight gain (median, 5.1 kg; range, 0.9 to 20.1 kg) and appetite enhancement in 27 of the 28 patients with breast cancer receiving treatment consisting of high doses of oral megestrol acetate (480 to 1600 mg/d). Weight gain occurred regardless of pretreatment weight, extent of metastases, or response to therapy. Our results suggest a possible role for megestrol acetate in reversing anorexia and weight loss, thereby improving the quality of life of patients with cachexia. Further research is needed to establish the mechanism of weight gain and potential clinical applications.
Treatment of anorexia and weight loss with megestrol acetate in patients with cancer or acquired immunodeficiency syndrome. [2018]Anorexia is a symptom of cancer and a cause of decreased caloric intake and weight loss. Successful treatment for anorexia can improve the patient's well-being and prevent or reverse the effects of anorexia on nutrition. Following reports of appetite enhancement and weight gain in uncontrolled studies of high-dose (320 to 1,600 mg/d) megestrol acetate in patients with cancer or AIDS (acquired immunodeficiency syndrome), several randomized, placebo-controlled trials have been completed. These trials demonstrate that megestrol acetate therapy improves appetite and food intake in patients with anorexia and advanced cancer, leading to weight gain in a subset of patients. The mechanisms of action of megestrol acetate (a progesterone derivative) probably include both behavioral and metabolic effects. Several carefully designed randomized trials are under way to establish the optimal dose and to determine the mechanism of weight gain. Patients with cancer or AIDS who complain of anorexia and whose nutritional status is compromised may benefit from megestrol acetate therapy.
Megestrol acetate for the palliation of anorexia in advanced, incurable cancer patients. [2013]Anorexia, or loss of appetite, is a troubling symptom for many patients with advanced cancer. The early observation that breast cancer patients, who were prescribed megestrol acetate as a cancer treatment, went on to increase their appetite and gain weight has given rise to a large number of clinical trials that have tested this progestational drug as a palliative agent for the cancer anorexia/weight loss syndrome. This review focuses on these trials, summarizing their findings and providing a practical approach for prescribing megestrol acetate to advanced cancer patients who suffer from the cancer anorexia/weight loss syndrome.
A Systematic Review and Meta-Analysis of the Clinical Use of Megestrol Acetate for Cancer-Related Anorexia/Cachexia. [2023]Cancer-related anorexia/cachexia is known to be associated with worsened quality of life and survival; however, limited treatment options exist. Although megestrol acetate (MA) is often used off-label to stimulate appetite and improve anorexia/cachexia in patients with advanced cancers, the benefits are controversial. The present meta-analysis aimed to better elucidate the clinical benefits of MA in patients with cancer-related anorexia/cachexia. A systematic search of PubMed, EMBASE, OVID Medline, Clinicaltrials.gov, and Google Scholar databases found 23 clinical trials examining the use of MA in cancer-related anorexia. The available randomized, controlled trials were appraised using Version 2 of the Cochrane risk-of-bias tool (RoB 2) and they had moderate-to-high risk of bias. A total of eight studies provided sufficient data on weight change for meta-analysis. The studies were divided into high-dose treatment (>320 mg/day) and low-dose treatment (≤320 mg/day). The overall pooled mean change in weight among cancer patients treated with MA, regardless of dosage was 0.75 kg (95% CI = −1.64 to 3.15, τ2 = 9.35, I2 = 96%). Patients who received high-dose MA tended to have weight loss rather than weight gain. There were insufficient studies to perform a meta-analysis for the change in tricep skinfold, midarm circumference, or quality of life measures. MA was generally well-tolerated, except for a clear thromboembolic risk, especially with higher doses. On balance, MA did not appear to be effective in providing the symptomatic improvement of anorexia/cachexia in patients with advanced cancer.
Megestrol acetate for the treatment of anorexia-cachexia syndrome. [2018]Megestrol acetate (MA) is currently used to improve appetite and to increase weight in cancer-associated anorexia. In 1993 MA was approved by the USA's Federal Drug Administration for the treatment of anorexia, cachexia, or unexplained weight loss in patients with AIDS. The mechanism by which MA increases appetite is unknown, and its effectiveness for anorexia and cachexia in neoplastic and AIDS patients is under investigation.
Treatment of anorexia with megestrol acetate. [2017]Anorexia and involuntary weight loss are prevalent problems in oncology and AIDS patients. Cytokines are suspected but not proven causes of cachexia. Megestrol acetate has been found to increase appetite, food intake, and weight in randomized, placebo-controlled trials in patients with advanced malignancies and in patients with AIDS. This hormone derivative probably has both central nervous system and peripheral metabolic effects. No significant effect on survival has been demonstrated in these trials. The optimal dose for appetite enhancement is unknown; we have chosen 320 mg/d as our initial dose. Megestrol acetate is usually well tolerated, and it may be helpful in the symptomatic and palliative therapy of patients with anorexia and weight loss.