JPRN-jRCT1071210053
Recruiting
N/A
A prospective observational study of the effect of ANamorelin Administration on combined immunochemotherapy in patients with non-small cell lung cancer - SPIRAL-ANA study
chino Junji0 sites127 target enrollmentAugust 24, 2021
Conditionsnon-small cell lung cancer
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- non-small cell lung cancer
- Sponsor
- chino Junji
- Enrollment
- 127
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Patients aged 20 or older at the time of informed consent).
- •2\) Patients who are to receive combined immunochemotherapy and who are to receive anamorelin 7 days prior to and on the same day as the first dose.
- •3\) Patients with histologically or cytologically confirmed non\-small cell lung cancer.
- •4\) Patients with Stage III/IV or postoperative recurrence who are not eligible for radical radiation therapy or resection.
- •5\) Patients with positive driver gene should be treated with kinase inhibitors.
- •6\) Patients who have not been treated with cell\-killing anticancer agents for advanced stage or postoperative recurrence lung cancer. However, preoperative and postoperative adjuvant chemotherapy is acceptable.
- •7\) Patients who meet the criteria for administration of anamorelin.
- •Patients with weight loss of 5% or more and anorexia within 6 months, and at least 2 of the following (1\) to (3\)
- •(1\) Fatigue or malaise
- •(2\) General muscle weakness
Exclusion Criteria
- •1\) Patients with contraindications to anamorelin administration.
- •(1\) Patients with congestive heart failure
- •(2\) Patients with myocardial infarction or angina pectoris
- •(3\) Patients with severe stimulation conduction system disorder (e.g. complete atrioventricular block)
- •(4\) Patients receiving the following drugs: clarithromycin, indinavir, itraconazole, nelfinavir, saquinavir, telaprevir, voriconazole, ritonavir\-containing products, cobicistat\-containing products.
- •(5\) Patients with moderate or severe hepatic dysfunction (Child\-Pugh classification B and C)
- •(6\) Patients with a history of hypersensitivity to any component of anamorelin.
- •(7\) Patients with difficulty in oral intake of food due to organic abnormalities of the gastrointestinal tract such as gastrointestinal obstruction.
- •2\) Patients with poorly controlled diabetes mellitus.
- •3\) Patients with intractable nausea and vomiting, chronic gastrointestinal disorders, inability to swallow preparations, or a history of gastrectomy or other procedures that may significantly affect the absorption of anamorelin.
Outcomes
Primary Outcomes
Not specified
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