Synergy of de-walled Ganoderma Lucidum spore powder (GLSP) on targeted therapy in advanced non-squamous non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutant: protocol for a randomized, double-blind, placebo-controlled study

Table 1 Trial visit schedule

Study stage		Baseline	Therapeutic period				Follow-up period
Point of visit			1	2	3	4	5	6
Follow-up time points^a		7 days before treatment	Day 14 of treatment	Day 28 of treatment	Day 42 of treatment	Day 56 of treatment	Day 14 after treatment	Day 28 after treatment
Time point (days)		-7 to 0	14	28	42	56	70	84
Visit windows (days)		± 3	± 3	± 3	± 3	± 3	± 7	± 7
Informed Consent		×
Inclusion and exclusion criteria		×
Demographic data		×
History of diagnosis and treatment		×
Blood and stool samples collected		×				×
Laboratory and aided examination	Liver/ Renal/ Blood/ Urine/ Stoolfunction test	×				×
	Twelve items of cytokines	×				×
	Imageological examination	×			×			×
	ECG	×				×
QLQ-C30/ PFS-CV/ EQ-5D		×	×	×	×	×		×
Evaluation of adverse reactions		×	×	×	×	×		×
AE&SAE		×	×	×	×	×		×
Compliance evaluation		×	×	×	×	×		×
Combination drug		×	×	×	×	×		×

Abbreviations ECG electrocardiograph, QLQ-C30 Quality of Life Questionnaire for Cancer Patients, PFS-CV Chinese version of the Piper Fatigue Scale, EQ-5D European Five Dimensional Health Scale, AE adverse events, SAE serious adverse event
^aPatients will be followed up every two weeks

ISSN: 2662-7671