Examination of the efficacy of anamorelin in chemotherapy for gastric cancer patients with cachexia

Examination of the efficacy of anamorelin in chemotherapy for gastric cancer patients with cachexia - Examination of the efficacy of anamorelin in chemotherapy for gastric cancer patients with cachexia

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000046056

Enrollment

Registered

2021-11-15

Start date

2021-11-15

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

gastric cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who are scheduled or undergoing chemotherapy containing S-1 for unresectable advanced gastric cancer or postoperative recurrent gastric cancer 2. Patients with cachexia who are covered by anamorelin insurance: Within 6 months, 5% or more weight loss and loss of appetite are observed, and two or more of the following A to C are observed. (A) Fatigue or fatigue (B) Weakness of the whole body (C) One or more of CRP> 0.5mg / dL, Hb <12g / dL, Alb <3.2g / dL 3. Patients scheduled to receive anamorelin 4. Patients who have received sufficient explanation before participating in this study, and who have obtained the patient's free will to consent to the document after sufficient understanding.

Exclusion criteria

Exclusion criteria: 1. Patients with gastrointestinal disorders who have difficulty in taking food orally or who require gastrointestinal rest 2. Patients with congestive heart failure, underlying heart disease (valvular disease, cardiomyopathy, etc.), history of myocardial infarction or angina, conduction system disorder, risk of QT interval prolongation or a history thereof 3. Patients with a history of administration of anthracyclines 4. Patients receiving strong CYP3A4 inhibitors (drugs containing clarislomycin, indinavir, itraconazole, nelfinavir, saquinavir, telaprevir, voriconazole, ritonavir, cobicistat) 5. Patients who have confirmed ascites in an amount exceeding the physiological range 6. Patients with confirmed pleural effusion 7. Patients with moderate or higher liver dysfunction (Child-Pugh classifications B and C) 8. Patients judged by the attending physician to be inappropriate for participation in the study

Design outcomes

Primary

Measure	Time frame
Body weight change rate 12 weeks after anamorelin administration	—

Countries

Japan

Contacts

Public ContactFumihiko Hatao

Tokyo Metropolitan Tama Medical Center Department of Surgery

fchobi@gmail.com0423235111

Outcome results