People with cancer can be very tired, because of the cancer itself or as a side effect of cancer chemotherapy. In addition, many cancer patients suffer from depression. Appetite is often affected by advanced cancer. Medications that stimulate attention and increase endurance are often used to control these symptoms. Provigil (modafinil) is a psychostimulant that was not designed for cancer patients and it is used mainly to treat people with narcolepsy. It has some troublesome side effects. In a clinical trial for narcolepsy, 74 of the 934 patients (8%) who received PROVIGIL dropped out compared to 3% of patients that received placebo. The most frequent reasons for stopping Provigil were headache, nausea, anxiety, dizziness, difficulty sleeping, chest pain and nervousness. NCCN publishes (National Cancer Centers Network) well accepted guidelines and it recommends psychostimulants for some cases of severe cancer related fatigue. Provigil is not an amphetamine and it is of a different class than other psychostimulants. Medical literature supports it for cancer fatigue and especially for the fatigue of brain cancer.
There were two prospective open-label studies of modafinil (Provigil). One study showed positive effects on fatigue that had persisted for an average of 2 years following breast cancer treatment. For these patients, fatigue severity and other measures of quality of life were significantly improved following 1 month of treatment with modafinil. Another recent study of 30 patients with malignant and benign brain tumors who were treated with surgery, radiotherapy, and/or chemotherapy found that modafinil was associated with significant improvements in fatigue scores. The most commonly reported adverse effects of modafinil treatment were headache, infection, nausea, nervousness, anxiety, and insomnia, all of which were generally mild. Randomized clinical trials of modafinil are under way to investigate its effect on cancer related fatigue in patients receiving chemotherapy and those who have completed chemotherapy or radiation therapy.
A phase III trial was presented at the 2008 meeting of the American Society of Clinical Oncology in Chicago, May 30-June 2. It included 642 patients with cancer-related fatigue who were undergoing chemotherapy for a variety of cancers. Patients were randomized to receive Provigil (n=320) or placebo (n=322) and were evaluated for fatigue, sleepiness, and depression at two different time points. Patients with severe baseline fatigue had significant improvement on Provigil compared with placebo (p=0.017). However, patients with mild to moderate fatigue did not show improvement. All patients in the study appeared to have less “sleepiness” than in the control group (p=0.002). Provigil had no effect on depression. The authors concluded that Provigil could be of benefit in treating severe cancer-related fatigue.
The subject was discussed at ASCO educational meeting in 2010.
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