Phase II Study of Anamorelin with Nutritional and Exercise Treatment for Cancer Cachexia (NEXTAC-III)

JRCT ID: jRCTs041210053

Registered date:17/08/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Elderly Patients with advanced non-small cell lung and pancreatic cancer
• Date of first enrollment: 29/11/2021
• Target sample size: 90
• Study type: Interventional

Intervention(s)

1)Standard chemotherapy:
Lung cancer: carboplatin + pemetrexed +-pembrolizumab,
carboplatin + nab-paclitaxel +- pembrolizumab, pembrolizumab, or docetaxel
Pancreatic cancer: Nanoliposomal irinotecan + 5-fluorouracil + leucovorin
2)Anamorelin hydrochloride: 100mg once daily p.o. (12 weeks)
3)Nutrition & Exercise program: A combination of nutritional counseling, home-based resistance training, and physical activity promotional counseling. (12 weeks)

Outcome(s)

• Primary Outcome: The proportion of patients with a clinically meaningful reduction in 6-minute walking distance or unable to assess

Secondary Outcome

1)Participation rate
2)Change in 6-minute walking distance
3)Change in global QOL score in EORTC-QLQ-C30
4)Change in FAACT anorexia score
5)Change in bodyweight
6)Change in skeletal muscle index
7)Disability-free survival
8)Overall survival
9)Safty
10)Compliance for anamorelin hydrochloride
11)The proportion of patients with a clinically meaningful reduction in 6-minute walking distance orunable to assess (whole registered population)

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Naito Tateaki
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development