Characteristic

Cancer Patients (N=45)

Healthy Controls (N=20)

p-value

Stage 4, Grade G3 Tumors

45 (100%)

-

-

Age (years)

18-75

18-77

-

Sex

19 men
26 women

7 men
13 women

-

BMI

24.4

22.8

-

Nocturnal Plasma Melatonin (pg/mL)

12.3 ± 3.5

38.7 ± 6.4

<0.001

Urinary Melatonin Sulfate (level)

Lower than controls

-

-

Outcome

Cancer Patients

Patients on Placebo

p-value

Tumor Size Reduction (%)

-28.3 ± 12.2

-2.4 ± 8.3

<0.001

Time-Treatment Interaction

F(1,43) = 62.3

-

<0.0001

Urinary Melatonin Sulfate Increase

Fold increase 4.1 ± 1.5

-

<0.001

IC50 Value Decrease (%)

38

-

<0.01

Complete Response Rate (%)

22.2

4.5

0.029

Subgroup Characteristic

Measure

Statistical Significance

Baseline Melatonin Sulfate Excretion

Higher antitumor effects

p=0.037

Dose of Melatonin

Significant tumor size reduction

R² = 0.33, p<0.001 for trend