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 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).
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]