Efficacy and mechanisms of cannabis oil for alleviating side effects of breast cancer chemotherapy (CBC2): protocol for randomized controlled trial

Table 1 SPIRIT schedule of enrolment and assessments

#	Timepoint	Week-0 baseline	Week-1 follow-up	Week-6 follow-up	Week-12 follow-up
#	Timepoint	T1	T2	T3	T4
1	Enrolment
	Eligibility screening	x
	Informed consent	x
	Allocation	x
2	Assessment
	CRF01 Case Record Form^a	x
	CRF02 FW & ADR^b	x	x	x	x
	CRF03 ESAS	x		x	x
	CRF04 EQ-5D-5 L	x		x	x
	CRF05 Food Frequency Questionnaire	x		x	x
3	Blood Samples, Serum
	Blood Chemistry^c	x			x
	Cytokines^d	x			x
	Bacterial Metabolites^e	x			x
	Pharmacokinetics parameters	x		x
	Pharmacogenetics parameters	x		x
4	Feces Samples
	Fecal Microbiome Profile	x			x
	Fecal Bile Acid Profile^f	x			x
	Fecal SCFAs^g and BCFAs^h	x			x
5	Skin Samples
	Skin Microbiome Profile	x			x
6	Saliva Samples
	Oral Microbiome Profile	x			x

^aDemographic and Epidemiological Factors: age, weight, height, waist circumference, hip circumference, neck circumference, alcohol consumption, smoking status, occupation, monthly income, method of health payment, and highest education
^bFollow up and adverse drug reaction: vital signs, physical examination, lab results to assess liver, kidney and heart function, pharmacokinetic record form, drug tolerance assessment form, and adverse event assessment form
^cBlood Chemistry: lipid profile, liver function test (LFT)
^dCytokines: interleukin-17, interferon-gamma, Interleukin-10, tumor growth factor-beta
^eBacterial Metabolites: lipopolysaccharide binding protein, sCD14 levels, equol, cadaverine
^fFecal Bile Acid Profile: chenodeoxycholic acid, deoxycholic acid, lithocholic acid
^gSCFAs: butyric acid, propionic acid, acetic acid
^hBCFAs: iso-butyric acid

ISSN: 2662-7671