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Pilot study to determine the effects of dronabinol on hot flash relief in breast cancer patients.

By July 15, 2004 No Comments
J Clin Oncol. 2004 Jul 15;22(14_suppl):8189.

Abstract

pm-2-site-2078189 Background: Hot flashes are a menacing problem, affecting 50-85% of menopausal women, with the incidence in breast cancer (BC) patients greater, due to antiestrogen therapy. Currently, the most effective treatment, hormone replacement therapy (HRT), is not recommended in BC patients and alternative therapies are sought. These include certain antidepressants and natural supplements showing a 55% and 30% reduction from baseline, respectively. This study sought to determine the efficacy of dronabinol (Marinol®) on hot flash relief. Marinol® has never been evaluated in this clinical setting.

METHODS:

Currently sixteen patients have been enrolled in this pilot study. Women diagnosed with BC and suffering from hot flashes were screened for enrollment and eligible if inclusion/exclusion criteria were met. The European Organization for Research and Treatment of Cancer Quality of Life (QoL) (EORTC QLQ-C30) questionnaire was completed, along with a daily hot flash log for five weeks. Hot flash scores were calculated based on frequency and severity as previously published by Loprinzi et al (J Clin. Oncol. 2001;19:4280-4290). A baseline week was recorded prior to a four week regimen of 5.0 mg of Marinol® a day, orally. All adverse events and toxicities were monitored.

RESULTS:

Results are currently available for eleven patients (n=11). Average hot flash scores at baseline ranged from 4.6 to 76.9, with a mean baseline of 26.1 [Formula: see text] 22.9 (mean and sd) to 15.4 [Formula: see text] 17.4 after four weeks of treatment. There was a 59% average greatest reduction from baseline. A significant statistical difference in QoL scores from Marinol® administration was not observed. Common side effects included headache (n=3) and insomnia (n=3).

CONCLUSIONS:

Marinol® administration resulted in a significant decrease in hot flash scores, due to decrease in frequency and severity. The percentage of reduction is comparable to standard treatments and provides a viable alternative therapy. No significant financial relationships to disclose.

PMID: 28015454
[PubMed – in process]
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