Results from a study testing methylphenidate for cancer-related fatigue

CHICAGO — Cancer-related fatigue is often a major problem for cancer patients, beginning at diagnosis, during treatment and after completing therapy. Researchers at Mayo Clinic (http://www.mayoclinic.org/oncology-rst/) and the North Central Cancer Treatment Group (http://ncctg.mayo.edu/) (NCCTG) recently completed a study testing methylphenidate in the treatment of cancer-related fatigue and found that, while it did not improve fatigue for a broad group of patients, the data did not rule out a benefit for those with stage III/IV cancer. Results of this NCCTG study, N05C7, will be presented on Sunday, June 6, 2010, at the American Society of Clinical Oncology (http://www.asco.org/) annual meeting in Chicago.

VIDEO ALERT: Additional audio and video resources, including excerpts from an interview with Dr. Deb Barton is available on the Mayo Clinic News Blog (http://newsblog.mayoclinic.org/2010/06/02/mayo-clinic-study-shows-drug-may-be-effective-in-treating-cancer-related-fatigue-in-some-patients/).

“Cancer-related fatigue can impact a patient’s ability to tolerate therapy and their overall quality of life,” says Debra Barton, R.N., Ph.D., associate professor of oncology at Mayo Clinic in Rochester, Minn., and an investigator for the study. “While our study did not demonstrate improvement in fatigue for a broad patient population, our results do not rule out some benefit for patients with advanced cancer and point to the need for further research.”

The study included 148 adult patients with cancer-related fatigue. Of these, 74 were randomized to receive long-acting methylphenidate and 74 were randomized to receive a placebo over a four-week period. Patients taking methylphenidate were titrated from 1 to 3 tablets in order to reach the target dose of 54 mg per day. To be part of the study, patients had to report fatigue that was defined as a score of greater than or equal to 4 on an 11-point Brief Fatigue Inventory (BFI) scale.

Methylphenidate is one of a group of psychostimulants that “wake up” or stimulate the central nervous system in the brain, producing chemicals such as dopamine and norepinephrine, which cause a person to be alert. In this study, a long-acting dose was selected to deliver a constant level of medication in the bloodstream throughout the day.

In the study, all participants rated their usual fatigue on the BFI every week for four weeks. Fatigue was rated on a scale of 0 to 10, with 0 being no fatigue and 10 being severe fatigue.

Results indicated no significant difference between the methylphenidate and placebo groups for usual fatigue over the four-week period. “In patients with stage III/IV disease, however, there appeared to be a difference in the fatigue score between the two arms,” says Dr. Barton. “In addition, there was a trend for patients receiving methylphenidate to be more satisfied with their treatment compared to those on the placebo arm. Caution should be used in interpreting these results, as this was an exploratory analysis and should only be used to generate hypotheses for future research,” Dr. Barton says.

As far as side effects, Dr. Barton adds, “Anxiety and appetite loss were more prominent in patients on the treatment arm. There was no significant difference in the incidence of other potential side effects such as insomnia and dizziness between the two groups, but side effects, in general, were more often observed in the patients receiving the active drug.”

“When considering using methylphenidate in the treatment of cancer-related fatigue, patients and their physicians need to consider the benefits and side effects of the medication,” says Dr. Barton.

According to Dr. Barton, “Currently, we are developing a new study to test a newer psychostimulant medication for cancer-related fatigue in patients with advanced cancer. Hopefully, it will be more effective and less toxic.”

Other study investigators include Amanda Moraska, Amit Sood, M.D., Jeff Sloan, Ph.D., and Charles Loprinzi, M.D., all of Mayo Clinic; Jason Suh, M.D., Joliet Oncology-Hematology Associates, Ltd., Joliet, Ill.; Patricia Griffin, M.D., SRHS Update Carolina Community Clinical Oncology Program, Spartanburg, S.C.; David Johnson, M.D., Wichita CCOP, Wichita, Kan.; Aneela Ali, M.D., Geisinger Medical Center, Danville, Pa.; and Peter Silberstein, M.D., Missouri Valley Cancer Consortium, Omaha, Neb.

About Mayo Clinic

For more than 100 years, millions of people from all walks of life have found answers at Mayo Clinic. These patients tell us they leave Mayo Clinic with peace of mind knowing they received care from the world’s leading experts. Mayo Clinic is the first and largest integrated, not-for-profit group practice in the world. At Mayo Clinic, a team of specialists is assembled to take the time to listen, understand and care for patients’ health issues and concerns. These teams draw from more than 3,700 physicians and scientists and 50,100 allied staff that work at Mayo Clinic’s campuses in Minnesota, Florida, and Arizona; and community-based providers in more than 70 locations in southern Minnesota, western Wisconsin and northeast Iowa. These locations treat more than half a million people each year. To best serve patients, Mayo Clinic works with many insurance companies, does not require a physician referral in most cases and is an in-network provider for millions of people. To obtain the latest news releases from Mayo Clinic, go to www.mayoclinic.org/news. For information about research and education, visit www.mayo.edu. MayoClinic.com (www.mayoclinic.com) is available as a resource for your general health information.


Substack subscription form sign up
The material in this press release comes from the originating research organization. Content may be edited for style and length. Want more? Sign up for our daily email.