Phase II Study of Anamorelin with Nutritional and Exercise Treatment for Cancer Cachexia (NEXTAC-III)
- Conditions
- Elderly Patients with advanced non-small cell lung and pancreatic cancer
- Registration Number
- JPRN-jRCTs041210053
- Lead Sponsor
- aito Tateaki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
1)Age >= 65years and ECOG-PS 0 or 1
2)Histologically or cytologically proven advanced (locally advanced or metastatic) non-small cell lung or pancreatic cancer
3)Cancer cachexia with an indication of anamorelin hydrochloride
4)Scheduled new systemic chemotherapy (first-line in non-small cell lung cancer and second-line in pancreatic cancer)
5)More than three months of expected survival time
6)Written informed consent was obtained
1)Having an indication for curative radiotherapy or surgery
2)Having a severe psychiatric disorder, an active infectious disease, unstable cardiopulmonary disease, uncontrolled diabetes mellitus, or severe liver dysfunction
3)Inability to ingest, digest, or absorb food or oral medications
4)Having symptomatic brain or bone metastases that prevented safe assessments or interventions
5)Contraindicated for anamorelin hydrochloride
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of patients with a clinically meaningful reduction in 6-minute walking distance or unable to assess
- Secondary Outcome Measures
Name Time Method 1)Participation rate<br>2)Change in 6-minute walking distance<br>3)Change in global QOL score in EORTC-QLQ-C30<br>4)Change in FAACT anorexia score<br>5)Change in bodyweight<br>6)Change in skeletal muscle index<br>7)Disability-free survival<br>8)Overall survival<br>9)Safty<br>10)Compliance for anamorelin hydrochloride<br>11)The proportion of patients with a clinically meaningful reduction in 6-minute walking distance orunable to assess (whole registered population)