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

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).

Conditions

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

Interventions

DRUG

Olanzapine

Given PO

DRUG

Placebo Administration

Given PO

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

• Oregon Health and Science University

  collaborator OTHER

• National Cancer Institute (NCI)

  collaborator NIH

• OHSU Knight Cancer Institute

  lead OTHER

Principal Investigators

• Eric Roeland, M.D., FAAHPM, FASCO · OHSU Knight Cancer Institute

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-17

Primary Completion

2026-12-31

Completion

2026-12-31

FDA Drug

Yes

Countries

• United States

Study Locations