Prospective observational study on gut microbiome as a novel biomarker for patients with cancer cachexia treated with anamorelin

Prospective observational study on gut microbiome as a novel biomarker for patients with cancer cachexia treated with anamorelin - Exploratory analysis of gut microbiome in patients with cancer cachexia

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000044137

Enrollment

120

Registered

2021-05-10

Start date

2021-05-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer cachexia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Unresectable advanced/recurrent non-small cell lung cancer, gastric cancer, pancreatic cancer, or colorectal cancer. 2. Subjects who is going to receive anamorelin in clinical practice for cancer cachexia (Cohort A). As a control, patients without cancer cachexia and patients with cancer cachexia who do not receive anamorelin are also included (Cohort B). 3. 20 years of age or older. 4. Signed informed consent form.

Exclusion criteria

Exclusion criteria: 1. Subjects who could not give their consent. 2. Subjects with illnesses or conditions that interfere with their capacity to understand, follow and/or comply with study procedures.

Design outcomes

Primary

Measure	Time frame
Changes in the composition of gut microbiome 3 weeks after the start of anamorelin	—

Secondary

Measure	Time frame
1. Association between the composition of gut microbiome at the start of anamorelin and its clinical effects 2. Clinical effects 3, 6 and 12 weeks after the start of anamorelin administration	—

Countries

Japan

Contacts

Public ContactTaiki Hakozaki

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Department of Thoracic Oncology and Respiratory Medicine

t-hakozaki@akane.waseda.jp03-3823-2101

Outcome results