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

ConditionsAdvanced Malignant Solid NeoplasmAdvanced Biliary Tract CarcinomaAdvanced Esophageal CarcinomaMetastatic Esophageal CarcinomaLocally Advanced Colorectal CarcinomaLocally Advanced Esophageal CarcinomaLocally Advanced Gastric CarcinomaMetastatic Colorectal Carcinoma (mCRC)Advanced Lung CarcinomaLocally Advanced Hepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOHSU Knight Cancer Institute

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

≥ 5% weight loss over the past 6 months

Disqualifiers

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

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Olanzapine

    Drug

    Given PO

  • Placebo Administration

    Drug

    Given PO

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

66 Participants
are divided into 3 treatment groups
Group A: Arm I (olanzapine, optional biospecimen collection)Experimental treatment 2 interventions
Group B: Arm IIExperimental treatment 2 interventions
Group C: Arm IIIPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Proportion of patients exhibiting weight gain greater 5%

\>5% weight gain comparing olanzapine 2.5mg (Arm I) vs. placebo (Arm III)

Time frame
Baseline to 12 weeks from baseline

Secondary outcomes

1

Change in Weight

\>5% weight gain comparing olanzapine 2.5 mg (Arm I) vs. olanzapine 5mg (Arm II) \>5% weight gain comparing olanzapine 5 mg (Arm II) vs. placebo (Arm III)

Time frame
Baseline to 12 weeks from baseline
2

Anorexia

Patient reported anorexia comparing olanzapine 2.5 mg (Arm 1) vs. olanzapine 5 mg (Arm 2) vs. placebo (Arm 3) Anorexia will be measured using the Functional Assessment of Anorexia-Cachexia Therapy (FAACT), a 12-item subscale of patients' perceptions of appetite (maximum score of 48, higher scores indicate less anorexia). A FAACT score ≤ 37 indicates anorexia.

Time frame
At 12 weeks from baseline]
3

Appetite

Change in appetite will be measured using the Visual Analog Scale for appetite (VAS), a 10-point scale with a higher score indicating a better appetite. A ≥3-point improvement in appetite at the end of the 12-week placebo-controlled Part A as compared to baseline in each arm will be considered an improvement in appetite.

Time frame
Baseline up to 12 weeks from baseline
4

Nutrition

Nutritional Status will be measured using the Patient- Generated Subjective Assessment Short Form (PG-SGA-SF); scored on a scale of 0-36 with a higher score indicating worse malnutrition.

Time frame
At baseline and at 4, 8, 12 weeks from baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

OHSU Knight Cancer Institute

Lead sponsor

Oregon Health and Science University

Collaborator

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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