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

Conditions

• Advanced Biliary Tract Carcinoma
• Advanced Esophageal Carcinoma
• Advanced Lung Carcinoma
• Advanced Malignant Solid Neoplasm
• Locally Advanced Colorectal Carcinoma
• Locally Advanced Esophageal Carcinoma
• Locally Advanced Gastric Carcinoma
• Locally Advanced Hepatocellular Carcinoma
• Metastatic Colorectal Carcinoma (mCRC)
• Metastatic Esophageal Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Olanzapine — DRUG
  Given PO
• Placebo Administration — DRUG
  Given PO
• Questionnaire Administration — OTHER
  Ancillary studies

Study Details

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).

Key Dates

Start date

Jul 17, 2024

Status verified

Jan 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

66 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Arm I (olanzapine, optional biospecimen collection)
  Patients receive a lower (2.5mg) dose of olanzapine orally (PO) nightly for 12 weeks in the absence of unacceptable toxicity. Patients may choose to enroll in an additional 12 weeks of treatment. Patients can choose to undergo computed tomography (CT) scan at baseline and monthly blood sample collections on study.
• Experimental: Arm II
  Patients receive a higher dose (5 mg) of olanzapine PO nightly for 12 weeks in the absence of unacceptable toxicity. Patients may choose to enroll in an additional 12 weeks of treatment. Patients undergo an optional baseline CT scan and collections of monthly blood samples on study.
• Placebo Comparator: Arm III
  ARM III: Patients receive placebo PO nightly for 12 weeks in the absence of unacceptable toxicity. Patients may choose to enroll in an additional 12 weeks of treatment. Patients undergo CT scan and monthly collection of blood samples on study.

Primary Outcome Measure

Proportion of patients exhibiting weight gain greater 5% [ Time Frame: Baseline to 12 weeks from baseline ]

Locations (1)

Find similar trials in Portland, OR

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