Table 1.
Summary of scheduled assessments.
| Procedures and assessments | Visit 1 Baseline |
Visit 2 Month 1 |
Visit 3 Month 2 |
Visit 4 Month 3 |
Visit 5 Month 4 |
Visit 6 Month 6 |
Visit 7 Month 9 |
Visit 8 Month 12 |
|---|---|---|---|---|---|---|---|---|
| Informed consent form | X | |||||||
| Demographic and general clinic data collection | X | |||||||
| Cancer staging | X | |||||||
| CT scheduling | X | |||||||
| Inclusion/exclusion criteria | X | |||||||
| Randomization | X | |||||||
| Anthropometry | X | X | X | X | X | X | X | X |
| Calorie and protein requirements | X | X | X | X | X | X | X | X |
| Calorie and protein intake | X | X | X | X | X | X | X | X |
| Symptoms | X | X | X | X | X | X | X | X |
| Biochemistry | X | X | X | X | X | X | X | X |
| Immunologic profile* | X | X | ||||||
| Body composition by bioelectric impedance | X | X | X | X | ||||
| Muscle mass by computed tomography | X | X | X | |||||
| Muscle strength | X | X | X | X | ||||
| Total CT received | X | |||||||
| CT toxicity | X | X | X | X | X | X | X | |
| Quality of life (EORTC QLQ-C30) | X | X | X | |||||
| Adverse event (safety) | X | X | X | X | X | X | X | |
| Unplanned hospitalization | X | X | ||||||
| HPN compliance* | X | X | X | X | X | X | X | |
| Survival status | X | X | X | X | X | X | X |
CT, chemotherapy; EORTC QLQ-C30, European Organization for Research and Treatment of Cancer core quality of life questionnaire version 3.0; HPN, home parenteral nutrition.
*
To be assessed only in patients randomized to early HPN.