A phase II study of methylphenidate for the treatment of fatigue.

Abstract

BACKGROUND:

Cancer-related fatigue (CRF) is one of the most distressing symptoms patients experience and is seen well after the completion of treatment. Methylphenidate (Ritalin) use includes the treatment of opiate-induced somnolence, depression, and reduced cognition. This phase II study was performed to evaluate the effects of methylphenidate on CRF.

PATIENTS AND METHODS:

The criteria for the eligibility of patients included the following: a history of breast cancer, absence of disease for greater than 6 months but less than 5 years, a hemoglobin level of >12 g%, less than moderate depression on the Brief Zung Self-administered Depression Scale, and a score of > or =4 on the Brief Fatigue Inventory (BFI). Patients received methylphenidate, 5 mg, orally, twice daily, for 6 weeks, with a dose escalation on week 2 if the BFI score remained > or =4 and no significant toxicities were reported. A response was defined as a decrease in the BFI score of at least two points on weeks 4 and 6 as compared to baseline.

RESULTS:

Between May 2001 and May 2003, 37 patients were entered and treated. On weeks 4 and 6, 20 of 37 (54%) responded with a decreased BFI score greater than two points, averaging a decrease of 3.5. Although six patients (19%) withdrew due to adverse events, these were reported as grade 1.

CONCLUSION:

This study suggests that women with breast cancer who are suffering from moderate to severe fatigue may benefit from methylphenidate.

• Authors: Amy Hanna, George Sledge, Mary Lou Mayer, Nasser Hanna, Lawrence Einhorn, Patrick Monahan, Joanne Daggy, Sumeet Bhatia
• Journal: Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer (Support Care Cancer) Vol. 14 Issue 3 Pg. 210-5 (Mar 2006) ISSN: 0941-4355 [Print] Germany
• PMID: 16096772 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Central Nervous System Stimulants
• Methylphenidate

Topics

• Adult
• Aged
• Breast Neoplasms
• Central Nervous System Stimulants (therapeutic use)
• Fatigue (drug therapy)
• Female
• Humans
• Indiana
• Methylphenidate (therapeutic use)
• Middle Aged
• Surveys and Questionnaires