Table 2.
Recommended content for the schedule according to the SPIRIT (Standard Protocol Items: Recommendation for Interventional Trials) 2013 guidelines.
| Time point | Enrollment | Allocation | Treatment | Follow-up | |||||||||
|
|
Week 1 | Week 0 | Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 |
|
Visit 6 | Visit 7 | Visit 8 |
|
|
| Enrollment | |||||||||||||
|
|
Eligibility screen | ✓ |
|
|
|
|
|
|
|
|
|
|
|
|
|
Informed consent | ✓ |
|
|
|
|
|
|
|
|
|
|
|
|
|
Allocation |
|
✓ |
|
|
|
|
|
|
|
|
|
|
| Intervention | |||||||||||||
|
|
Control group |
|
|
✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
|
|
CHMa group |
|
|
✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Assessment | |||||||||||||
|
|
ANCb or WBCc |
|
|
✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
|
|
Frequency of G-CSFd injection |
|
|
✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
|
|
Questionnaire |
|
|
✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
|
|
Immune cell profile |
|
|
✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
|
|
Adverse events |
|
|
✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
aCHM: Chinese herbal medicine.
bANC: absolute neutrophil count.
cWBC: white blood cell.
dG-CSF: granulocyte colony-stimulating factor.