The prophylactic and therapeutic effects of moxibustion combined with traditional Chinese medicine decoction for treating chemotherapy-induced myelosuppression in early-stage breast cancer: study protocol for a randomized controlled trial

Table 3 Schedule of enrolment and assessment

	Baseline	During chemotherapy (every cycle)	Follow-up after chemotherapy (month)
	0	1–8	6	12	18	24	36
Enrolment
Informed consent	√
Eligibility	√
General assessment
Age	√
Sex	√
Height	√
Weight	√	√
Body surface area	√
Surgical approach	√
Chemotherapy regimen	√
Chemotherapy strategy	√
Pathological stage	√
Molecular subtype	√
ECOG PS	√	√	√	√	√	√	√
EORTC QLQ-C30	√	√
EORTC QLQ-BR23	√	√
TCM constitution	√	√
Chest CT	√			√		√	√
*Breast MRI	√			√		√	√
Serum tumour biomarkers	√	√	√	√	√	√	√
Key evaluation
Blood routine test	√	At least once per week	√	√	√	√	√
Safety examination
Urine routine test	√	√	√	√	√	√	√
Liver function (ALT, AST, ALP, TBIL, GGT, etc.)	√	√	√	√	√	√	√
Kidney function (CR, BUN, SCR, UA, etc.)	√	√	√	√	√	√	√
Electrocardiogram	√	√	√	√	√	√	√
Adverse events		√	√	√	√	√	√
Data evaluation
Audit medical records		√	√	√	√	√	√
Ombudsman reviews medical records		√	√	√	√	√	√
Outcome measures		√	√	√	√	√	√

*MRI assessments were conditionally performed according to the patient’s disease status

ISSN: 1745-6215