Last updated on February 2019

Anamorelin Hydrochloride in Reducing Anorexia in Participants With Advanced Non-small Cell Lung Cancer


Brief description of study

Anorexia (loss of appetite) and weight loss are symptoms that are commonly associated with cancer. The goal of this clinical research study is to learn if the study drug (anamorelin) can help to control these symptoms in patients with advanced non-small-cell lung cancer.

Some participants will receive the study drug and some will receive a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

This is an investigational study. Anamorelin is not FDA approved or commercially available. It is investigational to give it to patients with non-small-cell lung cancer with loss of appetite and significant weight loss.

The study doctor can explain how the study drug is designed to work.

Up to 40 participants will be enrolled in this study. All will take part at MD Anderson.

Detailed Study Description

Objectives

Primary Objective:

  1. To qualitatively examine experiences related to anorexia in advanced lung cancer patients with anorexia-cachexia and the impact of nine weeks of treatment of oral Anamorelin (100 mg) and placebo. The primary outcome is to reach thematic saturation in the Anamorelin and placebo arms.

Secondary Objective:

  1. To explore changes in anorexia-cachexia (measured by the Functional Assessment of Anorexia/Cachexia Treatment [FAACT] anorexia/cachexia subscale [A/CS]) in patients with advanced non-small cell cancer after 9 weeks of oral Anamorelin (100 mg) or Placebo.
  2. To explore changes in anorexia as measured by the 5-item Anorexia Symptom score (derived from the FAACT A/CS) after 9 weeks of oral Anamorelin (100 mg) or Placebo.
  3. To explore any associations between changes in anorexia with body weight, body composition (as assessed by InBody, weight scale, and L3 vertebrae CT scan), quality of life (Functional Assessment of Cancer Illness Therapy (FACT-G), Patient Global Impression of Severity (PGIS), Patient Global Impression of Change (PGIC), nutritional markers (pre-albumin, IGF-1 and IGFBP-3), inflammatory biomarkers [C-Reactive Protein (CRP), monocyte IL-6&R, TNF-&R, IL-10,IL-8, IL-1&RA], and food intake after 9 weeks of oral Anamorelin (100 mg) or Placebo.

Clinical Study Identifier: NCT03637816

Contact Investigators or Research Sites near you

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M D Anderson Cancer Center

Houston, TX United States
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Recruitment Status: Open


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