NIPH Clinical Trials Search

JRCT ID: jRCTs041210053

Registered date:17/08/2021

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedElderly Patients with advanced non-small cell lung and pancreatic cancer
Date of first enrollment29/11/2021
Target sample size90
Countries of recruitment
Study typeInterventional
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)


Primary OutcomeThe proportion of patients with a clinically meaningful reduction in 6-minute walking distance or unable to assess
Secondary Outcome1)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 maximumNot applicable
Include criteria1)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 criteria1)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


Public contact
Name Koichi Takayama
Address 465 Kajiicho, kawaramachi- Hirokoji,Kamigyo-ku,Kyoto Kyoto Japan 602-8566
Telephone +81-75-251-5513
Affiliation University Hospital, Kyoto Prefectural University of Medicine
Scientific contact
Name Tateaki Naito
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Shizuoka Japan 411-8777
Telephone +81-55-989-5222
Affiliation Shizuoka Cancer Center