A randomised study with subcutaneous low-dose interleukin 2 alone vs interleukin 2 plus the pineal neurohormone melatonin in advanced solid neoplasms other than renal cancer and melanoma
1994

IL-2 and Melatonin in Advanced Solid Tumors

Sample size: 80 publication Evidence: moderate

Author Information

Author(s): P. Lissonil, S. Barnil, G. Tancinil, A. Ardizzoial, G. Ricci, R. Aldeghi, F. Brivio, E. Tisi, F. Rovelli, R. Rescaldani, G. Quadro, G. Maestroni

Primary Institution: San Gerardo Hospital, Monza, Milan, Italy

Hypothesis

Can the combination of interleukin 2 and melatonin improve treatment outcomes in advanced solid tumors?

Conclusion

The study shows that combining melatonin with low-dose interleukin 2 significantly increases tumor regression rates and overall survival in patients with advanced solid tumors.

Supporting Evidence

  • 3 out of 41 patients treated with IL-2 plus melatonin achieved a complete response.
  • 8 out of 41 patients treated with IL-2 plus melatonin achieved a partial response.
  • The objective tumor regression rate was significantly higher in patients treated with IL-2 and melatonin compared to those receiving IL-2 alone.
  • Survival at 1 year was significantly higher in patients treated with IL-2 and melatonin than in the IL-2 group.

Takeaway

This study found that giving a hormone called melatonin along with a treatment called interleukin 2 helps more people with serious tumors get better.

Methodology

80 patients with advanced solid tumors were randomized to receive either low-dose IL-2 alone or IL-2 plus melatonin, with responses evaluated after treatment.

Limitations

The study did not include patients with brain metastases or those receiving long-term steroid therapy.

Participant Demographics

{"gender_ratio":"M/F 43/37","median_age":55,"performance_status":"60 (Karnofsky's score)"}

Statistical Information

P-Value

p<0.001

Statistical Significance

p<0.05

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