Integrative Medicine > Melatonin  

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Ghielmini M, et al. Double-blind randomized study on the myeloprotective effect of melatonin in combination with carboplatin and etoposide in advanced lung cancer. Br J Cancer 1999;80:1058-61.
A prospective, randomized, double-blind, cross-over design study evaluating the effect of 40 mg oral melatonin supplementation on hematologic indices. Twenty previously untreated patients with inoperable lung cancer (16 non-small-cell and 4 small-cell) received two cycles of carboplatin (AUC = 5, Calvert formula) on day 1 and 150mg/m² IV etoposide on days 1-3 every 4 weeks. Melatonin or placebo was given once daily, initiated 2 days before chemotherapy and continued for 21 days. Patients were randomized to receive melatonin with either the first or the second cycle. Median age of the cohort was 60 years. Multivariate analysis including age, sex, diagnosis, stage, performance status, doses of carboplatin and etoposide, and concomitant treatment of melatonin or placebo, indicate no difference in hematological indices between treatment arms. No significant adverse effects related to melatonin were reported. Ghielmini et al. conclude that 40 mg oral melatonin does not improve hematologic status in lung cancer patients receiving carboplatin and etoposide.

Lissoni P, et al. A phase II study of tamoxifen plus melatonin in metastatic solid tumour patients. Br J Cancer 1996:74:1466-8.
A prospective, open-label evaluation of 20 mg melatonin and 20 mg tamoxifen in patients with metastatic solid tumors other than breast or prostate. Subjects were refractory to previous treatment, had poor performance status, or had no alternate treatment option. Twenty-five patients (M:F 10:15, aged 38-81, 6 unknown primary, 4 melanoma, 4 uterine cervical, 5 pancreatic, 3 hepatocarcinoma, 2 ovarian, 1 non-small cell lung) were administered melatonin at bedtime and tamoxifen at noon, regardless of estrogen receptor status until progression of disease or death. Patients received CT or MRI scan every 3 months and routine labs every 14 days. No complete response was documented. Three partial responses (12%) ranging from 5-8 months were recorded (melanoma, uterine cervical, and unknown primary). Stable disease, average duration 6 months, was noted in 13 patients (52%) while remaining 9 patients (36%) had progressive disease. No toxicity related to melatonin was reported. Lissoni et al. suggest that neuroendocrine treatment with 20 mg of melatonin and tamoxifen may be feasible for refractory solid tumors other than breast or prostate, but additional research is necessary.

Lissoni P, et al. A randomized study with the pineal hormone melatonin versus supportive care alone in patients with brain metastases due to solid neoplasms. Cancer 1994;73:699-701.
A prospective, randomized, open-label evaluation of patients with brain metastases from solid tumors refractory to radiation and nitrosourea-based chemotherapy. Patients were randomized to supportive care (n=26) or supportive care plus 20 mg melatonin once daily (n=24). Primary outcome was time to progression of disease and survival. Baseline characteristics and demographics did not differ significantly between groups. One year survival, progression of brain disease, and mean survival were significantly better in patients receiving melatonin as compared to placebo, 37% versus 12%, 5.9 versus 2.7 months, and 9.2 versus 5.5 months, respectively (p < 0.05). No adverse events related to melatonin were noted. Lissoni et al. suggest that melatonin reduces the frequency of hyperglycemia and steroid-related infective complications, and improves performance status. Additional research in controlled patient populations must be conducted to determine optimal dose for melatonin.