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Table 1 Patient characteristics by treatment arm

From: Methylene blue for intractable pain from oral mucositis related to cancer treatment: a randomized phase 2 clinical trial

Covariate

Treatment arm, no. (%)

Pa

CT alone, n = 16

CT+MB 0.025%, n = 15

CT+MB 0.05%, n = 14

CT+MB 0.1%, n = 15

 

Sex

    

0.9847

 Male

10 (63)

10 (67)

9 (64)

9 (60)

 

 Female

6 (38)

5 (33)

5 (36)

6 (40)

 

Age (in years), median (range)

48 (26–65)

45 (26–76)

43 (21–70)

32 (19–75)

0.5413

Race

    

0.8039

 White

15 (94)

11 (73)

11 (79)

11 (73)

 

 Black

1 (6)

1 (7)

0 (0)

1 (7)

 

 Asian

0 (0)

1 (7)

1 (7)

1 (7)

 

 Other

0 (0)

2 (13)

2 (14)

2 (13)

 

Therapy

    

0.2740

 CAR-T

0 (0)

0 (0)

1 (7)

1 (7)

 

 Chemotherapy

3 (19)

2 (13)

6 (43)

4 (27)

 

 SCT

13 (81)

13 (87)

7 (50)

10 (67)

 

Mucositis severity

    

0.1090

 Grade 2

1 (6)

0 (0)

1 (7)

4 (27)

 

 Grade 3

15 (94)

15 (100)

13 (93)

11 (73)

 

Mucositis location

    

0.8758

 Oral mucosa

8 (50)

9 (60)

8 (57)

7 (47)

 

 Esophageal

8 (50)

6 (40)

6 (43)

8 (53)

 

Baseline pain NRS score

    

0.9453

 0–5

4 (25)

2 (13)

3 (21)

3 (20)

 

 6–10

12 (75)

13 (87)

11 (79)

12 (80)

 

Baseline OFB score

    

0.6811

 0–3

2 (13)

2 (13)

3 (21)

1 (7)

 

 4–6

14 (88)

13 (87)

11 (79)

14 (93)

 

Pain duration (in days), median (range)

5.5 (3–8)

8 (2–90)

6 (1–43)

5 (2–30)

0.1046

OFB scoreb

 Baseline, median (range)

5 (2–6)

5 (2–6)

4.5 (2–6)

5 (2–6)

0.8428

 Day 1, median (range)

4.5 (1–6)

3 (0–5)

2 (0–5)

2 (0–6)

0.0210

 Day 2, median (range)

4 (0–6)

2 (0–5)

1 (0–5)

2 (0–5)

0.0008

 Reduction at day 2, mean ± SD

0.81 ± 1.11

2.47 ± 1.55

2.79 ± 1.72

2.87 ± 1.60

0.0008

MEDD baseline, median (range)

117.5 (16.4–825)

115 (12.5–535)

107 (15–648)

120 (5–3153)

0.9182

Pain NRS scorec

 Baseline, median (range)

6.5 (4–10)

8 (3–10)

7.5 (4–10)

8 (3–10)

0.1884

 Day 1, median (range)

6 (2–9)

4 (0–8)

3 (0–7)

3 (0–8)

0.0052

 Day 2, median (range)

5.5 (0–8)

3 (0–8)

2 (0–7)

2 (0–8)

0.0316

 Reduction at day 2, mean ± SD

1.69 ± 3.09

5.2 ± 2.81

4.54 ± 2.93

5.15 ± 2.64

0.0034

  1. Abbreviations: CTx conventional therapy, MB methylene blue, CAR-T chimeric antigen receptor T cell therapy, SCT stem cell transplantation, NRS numeric rating scale, OFB oral functioning burden, MEDD morphine equivalent daily dose
  2. aReductions in pain NRS and OFB scores from baseline to day 2 among four treatment arms were compared using ANOVA
  3. bScores ranged from 0 to 6
  4. cScores ranged from 0 to 10