Oral Tetrahydrocannabinol (THC):Cannabinoid (CBD) Cannabis Extract Adjuvant for Reducing Chemotherapy-Induced Nausea and Vomiting (CINV): A Randomized, Double-Blinded, Placebo-Controlled, Crossover Trial

Figures & data

Table 1 Baseline Characteristic (n)

	Group A	Group B	p-value
Age (years)
18–29	–	–	0.518
30–49	9	7
50–69	15	18
≥ 70	3	2
BMI (kg/m^2)	25.1	27.9	0.116
Anticipatory CINV
No	9	8	0.311
Yes	18	19
ECOG Performance Status
0	6	7	1.000
1	20	19
2	1	1
Gynecologic malignancy
Ovarian cancer	10	12	0.623
Endometrial cancer	5	7
Cervical cancer	9	7
Others	3	1
Stages of cancer
Early stage	9	13	0.268
Advanced stage	18	14
Chemotherapy regimen
Carboplatin	18	20	0.551
Cisplatin	9	7

Abbreviations: BMI, body mass index; CINV, chemotherapy-induced nausea and vomiting; ECOG, Eastern cooperative oncology group.

Figure 1 Consort flow diagram.

Notes: CONSORT figure adapted from Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials. PLoS Med. 2010;7(3): e1000251. Copyright: © 2010 Schulz et al. Creative Commons Attribution License.¹²

Table 2 Mean Nausea Score Between THC:CBD and Placebo Groups

Time	THC:CBD* (95% CI)	Placebo* (95% CI)	p-value
Day 1	2.019 (1.646, 2.391)	3.113 (2.581, 3.644)	0.001
Day 2	2.189 (1.746, 2.631)	3.038 (2.605, 3.470)	0.007
Day 3	2.434 (1.931, 2.936)	2.962 (2.576, 3.348)	0.097
Day 4	2.094 (1.681, 2.507)	2.717 (2.333, 3.100)	0.029
Day 5	1.830 (1.481, 2.179)	3.151 (2.612, 3.689)	< 0.001
Total	2.113 (1.940, 2.315)	2.996 (2.795, 3.197)	0.001

Note: *Mean, THC: delta-9-tetrahydrocannabinol,

Abbreviation: CBD, cannabidiol.

Figure 2 Mean nausea score between group A and B.

Table 3 Side-Effects Between THC:CBD 1:1 and Placebo (N = 54)

Side-Effects	THC:CBD, n (%)	Placebo, n (%)	p-value
Sedation and dizziness	12 (22.2)	5 (9.3)	0.064
Sedation	16 (29.6)	10 (18.5)	0.176
Dizziness	20 (37)	20 (37)	1.000
Anxiety	5 (9.3)	4 (7.4)	0.727
Dry mouth	14 (25.9)	19 (35.2)	0.294
Confusion	6 (11.1)	4 (7.4)	0.506
Palpitations	1 (1.9)	0 (0)	0.315
Hallucination	1 (1.9)	0 (0)	0.315
Rash	4 (7.4)	5 (9.3)	0.727
Mood or behavior change	4 (3.7)	2 (3.7)	0.401
Anorexia	3.76*	4.057*	0.47

Note: *Mean, THC: delta-9-tetrahydrocannabinol.

Abbreviation: CBD, cannabidiol.

Table 4 Summarized Data from Previous Literature of Cannabinoid Extract and Chemotherapy in Chemotherapy-Induced Nausea and Vomiting (CINV) Aspects

Author	Duran	Turcott	Polito	Grimison	Present
Years	2010	2018	2018	2020	2022
Country	Spain	Mexico	Canada	Australia	Thailand
Study	R	R	RT	RC	RC
Cases	16	47	110	80	54
Age (years)	50	61.1	14	50–69	54.4
ECOG 0–2	–	100	–	100%	100%
Female	94	78	45	78	100
Intervention	THC:CBD	Nabilone	Nabilone	THC:CBD	THC:CBD
Doses (mg)	13:12	0.5–1	0.25	Self-0.5	0.25–0.4
Cancer	Multiple	NSCLC	Multiple	Multiple	Gyn
Stages III, IV (%)	–	100	–	–	59.3
HEC (%)	No	Yes	75.5	45	100
MEC (%)	Yes	Yes	24.5	55	–
NS (VAS)(mean)		16.6	–	3.2	3.7
CR (%)	71.4	–	52.3	25
Sedation (%)	66.6	–	20	19	29.6
Dizziness (%)	50	–	10	10	37
Dry mouth (%)	33.3	–	–	–	25.9
Anorexia (VAS)(mean)	–	51.8	–	–	3.76

Schulz KF, Altman DG, Moher D. CONSORT Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials. PLoS Med. 2010;7(3):e1000251.

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