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Title: Ritalin Conjugate Used to Treat "Chemo-Brain" in Breast Cancer Patients: Presented at SABCS

"Ritalin Conjugate Used to Treat "Chemo-Brain" in Breast Cancer Patients: Presented at SABCS"

By Cameron Johnston SAN ANTONIO, TX -- December 13, 2005 -- A drug that helps children with attention deficit/hyperactivity disorder (ADHD) to control their disruptive behavior -- dexmethylphenidate (d-MPH) -- can be a simple and relatively inexpensive means of treating chemotherapy induced fatigue and forgetfulness -- something cancer patients refer to as "chemo-brain". The methylphenidate formulation used is an enantiomer of racemic Ritalin, known as Focalin, which has also been approved in the US for the treatment of attention deficit hyperactivity disorder (ADHD). Stewart Fleishman, MD, director of cancer supportive services, Continuum Cancer Centers of New York, Beth Israel Medical Center, New York, New York, presented the results of a small study of women with breast cancer who were treated with d-MPH, at the 28[^th Annual San Antonio Breast Cancer Symposium (SABCS).

According to Dr. Fleishman, the drug is significantly superior to placebo for reducing fatigue and cognitive impairment caused by chemotherapeutic agents.

In his study, 168 subjects went through a prescreening process during which time they received a placebo and were told about the purpose of the trial. At the end of this process, patients who had reported an improvement in symptoms were excluded, because it indicated that they were experiencing a placebo effect. Of the remaining women, 75 were rerandomized to receive d-MPH 50 mg/day and 77 received placebo.

The women were not stratified as to which chemotherapy regimen they had been taking because so many regimens are available, Dr. Fleishman said. The most commonly used regimens were cyclophosphamide, doxorubicin, paclitaxel, 5-fluorouracil, methotrexate, docetaxel, and carboplatin.

Previous studies have shown that 99% of all lung and breast cancer patients experience fatigue and forgetfulness, and that this condition can last for months after chemotherapy has been discontinued, Dr. Fleishman said.

Women in the study were specifically excluded if they had any history of ADHD, any related or similar neurological or psychological condition, or if they had ever used Ritalin.

Women completed a Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) questionnaire before and after the 8-week treatment period.

Results showed statistically significant improvements after as little as 2 weeks of therapy and these improvements continued to the end of the study. Changes in FACIT-F scores approached 10 points at the end of the study in the d-MPH arm compared with 6 points in the placebo arm.

The idea for this study, Dr. Fleishman said, arose because patients who were taking opioid analgesics reported anecdotally using Ritalin to treat their fatigue.

Not only was the fatigue alleviated, he said, but all subjects in the study reported a positive effect on memory, and a positive trend for cognitive function.

These data now indicate that d-MPH should be considered for patients suffering from fatigue and forgetfulness as a result of their chemotherapy, Dr. Fleishman said.

A larger prospective study will still be needed to establish any firm conclusions about these latter findings, he added.

[Presentation title: A Phase II, Randomized, Placebo-Controlled Trial of the Safety and Efficacy of Dexmethylphenidate (D-MPH) as a Treatment for Fatigue and Chemobrain in Adult Cancer Patients. Abstract 5026]

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