Background
Standard of care for cancer cachexia
Cancer cachexia in elderly cancer patients
Results from early-phase prospective trial: the NEXTAC-ONE study
Aim of the NEXTAC-TWO study
Translational research of the NEXTAC-TWO study
Methods
Study design and participants
Inclusion Criteria | |
1) Diagnosis of advanced non-small cell lung cancer or inoperable pancreatic cancer | |
2) Scheduled for systemic cancer therapy (i.e. chemotherapy, and/or targeted therapy and/or immunotherapy) | |
i. In pancreatic cancer patients, planned systemic chemotherapy only allows of the combination of gemcitabine with nanoparticle paclitaxel. | |
3) Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 | |
4) Age ≥ 70 years | |
5) Body weight of 6 month ago can be confirmed | |
6) An expected survival of ≥3 months as judged by investigators | |
7) Written informed consent | |
8) Adequate organ function | |
i. Hemoglobin ≥8.0 g/dl | |
ii. Total bilirubin ≤2.0 mg/dl | |
iii. Aspartate aminotransferase ≤150 IU/L | |
iv. Alanine aminotransferase ≤150 IU/L | |
v. Serum creatinine ≤2.0 mg/dl | |
vi. Arterial oxygen saturation (SpO2) ≥ 90% or partial pressure of oxygen in arterial blood (PaO2) ≥ 60 Torr in room air | |
vii. Resting heart rate < 120 beat per minute | |
Exclusion criteria | |
1) Patients received prior chemotherapy except adjuvant chemotherapy | |
2) Active malignancy requiring cancer treatment including chemotherapy, radiotherapy and surgery within 3 months | |
3) Patients who need nursing care at following situation (based on Katz Index) | |
i. Bathing | |
ii. Dressing | |
iii. Transferring | |
iv. Feeding | |
4) Symptomatic brain metastasis or leptomeningeal carcinoma | |
5) Bone metastasis with high risk of fracture | |
6) Patients who are difficult to evaluate or intervene with cardiovascular disease, bone and joint disease, neuromuscular disease etc. | |
7) Patients who are difficult to participant due to psychiatric disorder | |
8) Patients who are difficult to oral intake | |
9) History of acute myocardial infarction, unstable angina, uncontrollable hypertension, and symptomatic sustained arrhythmia within 6 months. Stable atrial fibrillation treated with appropriate anticoagulation therapy is allowed. | |
10) Uncontrollable diabetes mellitus | |
11) Patients whose appropriate period has not passed since prior treatment | |
i. Surgery: 7 days | |
ii. Palliative radiation: 1 day | |
iii. Minor surgery (i.e. biopsy): 1 day | |
12) Screening failure | |
i. Patients who failed to wear the accelerometer for more than 4 days | |
ii. Patients who could not properly handle the accelerometer | |
iii. Patients who failed to initiate first-line therapy within 14 days of enrollment |
Assessments and interventions
Control arm | Intervention arm | |||||||
---|---|---|---|---|---|---|---|---|
Sessions | Time pointa | T1 | T2/T3 | T4 | T1 | T2/T3 | T4 | |
Detail of assessment/intervention | ||||||||
Nutritional sessions 30 min at T1 20 min at T2, T3, and T4 | Assessments | •Food intake | ○ | – | ○ | ○ | ○ | ○ |
• Nutritional status (MNAd) | ○ | – | ○ | ○ | ○ | ○ | ||
• Nutritional checklistb | ○ | – | ○ | ○ | ○ | ○ | ||
•Skeletal muscle analysis | ○ | – | ○ | ○ | – | ○ | ||
•Diet diary collection | – | – | – | – | ○ | ○ | ||
Interventions | • Nutritional advice | – | – | – | ○ | ○ | ○ | |
• Support for NISd management, food environment, and eating-related distress | – | – | – | ○ | ○ | ○ | ||
• ONSd prescriptionc | – | – | – | ○ | ○ | – | ||
Exercise session 30 min at T1 20 min at T2, T3, and T4 each for A and B. | Assessments | • Assessment of physical function (Hand-grip strength, SPPBd) | ○ | – | ○ | ○ | – | ○ |
• Exercise diary collection | – | – | – | – | ○ | ○ | ||
• Assessment of physical activity (Physical activity measurement, Physical activity interview) | ○ | – | – | ○ | ○ | ○ | ||
• EORTC-QLQ-C30 questionnaire | ○ | – | ○ | ○ | – | ○ | ||
Interventions | A. Home-based resistance training | |||||||
• Prescription (T1) and modification (T2, T3, T4) of exercise program | – | – | – | ○ | ○ | ○ | ||
• Instruction of exercise procedures | – | – | – | ○ | ○ | ○ | ||
•Education of self-modification | – | – | – | ○ | ○ | ○ | ||
B. Physical activity promotive counseling | ||||||||
• Prescription of target daily step | – | – | – | ○ | ○ | ○ | ||
• Physical activity counseling | – | – | – | ○ | ○ | ○ | ||
• Education of fall prevention | – | – | – | ○ | ○ | ○ |
Time points of assessments and interventions
Physical and exercise assessment
Nutritional assessment
Exercise and lifestyle interventions
Nutritional interventions
Study objectives
Primary endpoint | |
The disability-free survival | |
Secondary endpoint | |
1) Lean body mass assessed by CT | |
2) Physical function assessed by the hand-grip strength, SPPB score and physical activity measured by accelerometer | |
3) Nutritional status assessed by body weight, MNA score and ingested nutritional quantity | |
4) Quality of Life assessed by EORTC-QLQ-C30 | |
5) The proportion of patients treated with subsequent chemotherapy | |
6) Overall survival, Progression free survival | |
7) The cumulative number of days of hospitalization | |
8) Activity of daily life | |
9) Safety |