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Clinical study of melatonin in untreatable advanced cancer patients
P Lissoni1, S Barni, G Tancini
1Divisione di Radioterapia Oncologica, Ospedale San Gerardo, Monza, Milano, Italia.
Abstract:
It is known that the pineal gland has some antitumor activity. Melatonin, its most important hormone, has been shown to inhibit tumor growth in vivo and in vitro. Moreover, some investigations have demonstrated an altered melatonin secretion in cancer patients. Despite these interesting data, clinical trials have never been carried out to evaluate the effects of melatonin on human neoplasms. The aim of this study was to draw some preliminary conclusions on melatonin therapy in advanced human neoplasms. Nineteen patients suffering from advanced solid tumors, which did not respond to standard therapies, entered the study. Performance status (PS) was 20 or less in 9 cases, and more than 20 in the other 10. Melatonin was given intramuscularly at a daily dose of 20 mg at 3.00 p.m., followed by a maintenance period with lower doses in patients who had a remission, a stabilization of disease or an improvement in PS. Among patients with a PS higher than 20, a partial response was achieved in one case with cancer of the pancreas; moreover, 5 of 10 had stable disease, but the other 4 cases had a progression; an evident improvement of PS was obtained in 6 of the 10 cases. In contrast, among patients with a very poor PS, 7 of 9 died within the first 2 months of therapy. This preliminary study would suggest that melatonin may be of some value in treating cancer patients in whom standard antitumor therapies have failed, particularly in improving their PS and quality of life.
Insights
Melatonin, a pineal gland hormone, shows potential in treating advanced cancers unresponsive to standard therapies. It may improve performance status and quality of life, especially in patients with better initial health.
Area of Science:
- Oncology
- Endocrinology
- Pharmacology
Background:
- The pineal gland hormone melatonin exhibits known antitumor properties in preclinical studies.
- Altered melatonin secretion is observed in cancer patients, suggesting a role in neoplastic disease.
- Limited clinical data exists on melatonin's efficacy in human neoplasms.
Purpose of the Study:
- To conduct a preliminary evaluation of melatonin therapy in patients with advanced solid tumors.
- To assess melatonin's impact on tumor response, disease stabilization, and performance status.
Main Methods:
- Nineteen patients with advanced solid tumors refractory to standard treatments were enrolled.
- Melatonin was administered intramuscularly at 20 mg daily, with dose adjustments for responders.
- Patients were stratified based on Performance Status (PS > 20 vs. PS ≤ 20).
Main Results:
- In patients with PS > 20, one partial response (pancreatic cancer) and stable disease in 50% were observed; 60% showed improved PS.
- Patients with very poor PS (≤ 20) experienced high mortality, with 7 of 9 dying within two months.
- Melatonin therapy demonstrated potential for improving PS and quality of life in select advanced cancer patients.
Conclusions:
- Melatonin may offer therapeutic benefits for advanced cancer patients who have exhausted standard treatments.
- Efficacy appears linked to baseline patient performance status, with better outcomes in those with higher PS.
- Further clinical trials are warranted to confirm melatonin's role in cancer therapy and supportive care.