DRUG_REHAB

Morrow: Its not really known. There are a number of theories and people are going after a number of different things. Fortunately, for the majority of people it does get better, but for maybe a third of the people it can persist after treatment.

Q: So chemobrain does not just happen during treatment?

Morrow: No, it can persist. The people in the study that you mentioned were on average two years out from their treatment and still suffered memory problems, problems with executive functioning, problems with attention.

Q: There is nothing to prove why it happens with chemotherapy?

Morrow: It just seems to occur with chemotherapy more so than with radiation, or with other types of treatments. Hence, the term chemobrain, which seems to go along with chemotherapy treatment for cancer

Q: What types of treatment is being offered to these patients?

Morrow: A number of things, as you might suspect, have been tried. Nothing has been proven either before or since. We need to be clear on that. People have tried stimulant types of drugs -- phetamine based drugs. The street name would be speed, but there are medically appropriate uses for it. There are types of agents sometimes given to children who have difficulties with attention deficit disorder -- the sort of things that lots of college people use when they are staying up for exams and paper. They are basically stimulants that jazz up your system. They increase your attention. They increase everything including, unfortunately, your heart rate and a variety of things you dont want to increases. They also have difficulties in that with them come things like trouble sleeping, which doesnt make anything better if youre so jazzed up you cant get to sleep. So theyve been tried, but they have a variety of side effects that make them not terribly useful to take on a regular basis.

Q: You are now testing the drug modafinil (Provigil) on patients with chemobrain. Why did you decide to try that drug?

Morrow: Why that was tried is basically multifold. It is a stimulant type of drug, but its whats called a non-amphetamine based stimulant. In other words, it doesnt jazz up the entire system. Rather, it helps you maintain a particular level. Chemobrain difficulties with memory and so forth tend to be more pronounced at the end of the day when you are fatigued. We can talk of fatigue later if you like, but the point is, the drug tends to level things out and tends to sharpen the focus a bit. These are some things that were noticed. It is developed and approved by the FDA for a condition called narcolepsy, where people tend to have difficulties concentrating and fall asleep inappropriately. Its not an allied condition, but its one in which there were a number of things like memory and like attention that we thought might make this a reasonable thing to do.

Q: What is the typical dose for a patient with chemobrain?

Morrow: We used basically the approved 200 mg dose once a day. There are other doses that people use for other things. We thought as a start that made some sense for the open labeled study we did

Q: What are the results of your study?

Morrow: It involved about 70 people, who had been on average two years passed their cancer treatments and were still suffering from fatigue and from what was called chemobrain, in terms of troubles with attention, memory, concentration and those types of things. They were given the drug for essentially a two month period, open label. It was not a control. There was no placebo given to compare it with. We measured some of their cognitive function and memory attention and so forth when they first started taking the drug and then we measured it at the end. The changes we found were positive changes. In other words, it was useful for the people; they had better memory, better ability, for example, to remember words. One of the tests we performed on patients involved giving them a certain amount of words. Then you talk to the person for a while and then you have them remember what the words were. It's the same kind of thing if you have to remember a phone number, where you are remembering digits. They were practically oriented almost daily of activity sorts of things, and there were improvements not in everything, but in some things, like memory and the ability to put things together and the ability to concentrate, pay attention -- those types of issues.

Q: What do you think that means for a patient to be offered that kind of improvement, especially when they finished chemotherapy two years ago and are still dealing with the effects?

Morrow: The patients were very positive about it as well. As a matter of fact, one of the difficulties was when the study was over and we could no longer provide them with the free drug or could no longer provide the drug because it was not licensed for this use.

Q: Are there any side effects of modafinil?

Morrow: Everything has side effects. One of the side effects that some people pointed out was that every now and then it would interfere with their sleeping a little bit, which is interesting because one of its approved uses is for excessive daytime sleepiness. Other than that it was really well tolerated. Again, every drug has side effects of some type or another. The benefits seem to be greater than whatever those side effects were.

Q: What did your study on fatigue and cancer patients reveal?

Morrow: One of the things that is becoming more recognized now is that among the most prominent side effects of virtually any cancer treatment is fatigue. About nine out of 10 radiotherapy patients -- patients under going radiation treatment for cancer, will have fatigue some time during their treatment, which is typically a six week process. About eight out of 10 under going chemotherapy drug therapy for cancer will also report fatigue at some point during their treatment, so its extremely prevalent. It happens a lot. Not everyone is severely fatigued, but the average person is at least moderately fatigued during treatment, and there are a number of folks who are severely fatigued. Again, unfortunately about a third of the people have that fatigue persist once the treatment has ended, so we have two studies that we�ve done on that -- the same study that looked at the chemobrain will also measure fatigue, open label, no comparison. They were just given the drug and there was a very positive effect on fatigue in addition to the chemobrain. The people were very happy that they were now able to get out, feel better, able to engage in life and family activities and so forth. That led to a large scale trial funded by the National Cancer Institute where we studied over 600 people. What we did there was, half of them got modafinil and half of them got something that looked exactly like modafinil. Both were provided by the company. The National Cancer Institute provided the resources for the rest of it and it was done in 23 different medical groups throughout the country. What we found was basically the same thing we found in a pilot study, which is it was first of all very safe, well tolerated, few side effects that people had troubles with. More importantly, it had an effect when compared to the placebo and that effect was greater in people who were severely fatigued than in people who had mild or moderate fatigue, so the more fatigue you have, the better it seems to work

Q: Do you know the percentage of patients who responded well to the medication?

Morrow: We didnt measure it that way. It was basically a randomized clinical trial so that the metric is whether it was statistically significant versus not, and it was.

Q: Is this drug something a person could have a conversation with their doctor about?

Morrow: It is in fact a drug that is on the market. I believe there may also be generic forms of it around, but again, it�s not an indication that�s it�s approved for, which means there are issues in terms of insurance. There are issues in terms of the FDA. There are issues in terms of a variety of things that an individual is much better to take up with their physician and their individual healthcare system.

Q: What could this drug mean for treating cancer patients or helping them even more?

Morrow: It doesnt treat cancer. What it does is helps with some of the things that the disease and its treatment bring about. What it means is that the people may suffer a bit less. The people may be able to engage in activities of daily living and theyd be able to engage with their family and with their friends. For some people, either fatigue or chemobrain actually significantly impacts and interferes with their ability to make a living. We had people in the study who were quite high functioning professionals who literally were either not functioning up to their standards in their occupation or had to change occupations. Thats a sad and terrible thing, especially as it comes as a result of some treatment that hopefully enhanced and prolonged your life. In terms of those things, it could be a major thing, if again approved by the appropriate authorities.

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