Phase III, randomized, double-blind, placebo-controlled study of long-acting methylphenidate for cancer-related fatigue

North Central Cancer Treatment Group NCCTG-N05c7 trial

Amanda R. Moraska, Amit Sood, Shaker R. Dakhil, Jeff A. Sloan, Debra Barton, Pamela J. Atherton, Jason J. Suh, Patricia C. Griffin, David B. Johnson, Aneela Ali, Peter T. Silberstein, Steven F. Duane, Charles L. Loprinzi

Research output: Contribution to journalArticle

103 Citations (Scopus)

Abstract

Purpose: Fatigue is one of the most common symptoms experienced by patients with cancer. This trial was developed to evaluate the efficacy of long-acting methylphenidate for improving cancer-related fatigue and to assess its toxicities. Patients and Methods: Adults with cancer were randomly assigned in a double-blinded manner to receive methylphenidate (target dose, 54 mg/d) or placebo for 4 weeks. The Brief Fatigue Inventory was the primary outcome measure, while secondary outcome measures included a Symptom Experience Diary (SED), the Short Form-36 (SF-36) Vitality Subscale, a linear analog self-assessment, the Pittsburgh Sleep Quality Index, and the Subject Global Impression of Change. Results: In total, 148 patients were enrolled. Using an area under the serum concentration-time curve analysis, there was no evidence that methylphenidate, as compared with placebo, improved the primary end point of cancer-related fatigue in this patient population (P = .35). Comparisons of secondary end points, including clinically significant changes in quality-of-life variables and cancer-related fatigue change from baseline, were similarly negative. However, a subset analysis suggested that patients with more severe fatigue and/or with more advanced disease did have some fatigue improvement with methylphenidate (eg, in patients with stage III or IV disease, the mean improvement in usual fatigue was 19.7 with methylphenidate v 2.1 with placebo; P = .02). There was a significant difference in self-reported toxicities (SED), with increased levels of nervousness and appetite loss in the methylphenidate arm. Conclusion: This clinical trial was unable to support the primary prestudy hypothesis that the chosen long-acting methylphenidate product would decrease cancer-related fatigue.

Original languageEnglish
Pages (from-to)3673-3679
Number of pages7
JournalJournal of Clinical Oncology
Volume28
Issue number23
DOIs
StatePublished - Aug 10 2010

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Methylphenidate
Fatigue
Placebos
Neoplasms
Therapeutics
Outcome Assessment (Health Care)
Appetite
Sleep
Anxiety
Quality of Life
Clinical Trials
Equipment and Supplies

All Science Journal Classification (ASJC) codes

  • Cancer Research
  • Oncology
  • Medicine(all)

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Phase III, randomized, double-blind, placebo-controlled study of long-acting methylphenidate for cancer-related fatigue : North Central Cancer Treatment Group NCCTG-N05c7 trial. / Moraska, Amanda R.; Sood, Amit; Dakhil, Shaker R.; Sloan, Jeff A.; Barton, Debra; Atherton, Pamela J.; Suh, Jason J.; Griffin, Patricia C.; Johnson, David B.; Ali, Aneela; Silberstein, Peter T.; Duane, Steven F.; Loprinzi, Charles L.

In: Journal of Clinical Oncology, Vol. 28, No. 23, 10.08.2010, p. 3673-3679.

Research output: Contribution to journalArticle

Moraska, AR, Sood, A, Dakhil, SR, Sloan, JA, Barton, D, Atherton, PJ, Suh, JJ, Griffin, PC, Johnson, DB, Ali, A, Silberstein, PT, Duane, SF & Loprinzi, CL 2010, 'Phase III, randomized, double-blind, placebo-controlled study of long-acting methylphenidate for cancer-related fatigue: North Central Cancer Treatment Group NCCTG-N05c7 trial', Journal of Clinical Oncology, vol. 28, no. 23, pp. 3673-3679. https://doi.org/10.1200/JCO.2010.28.1444
Moraska, Amanda R. ; Sood, Amit ; Dakhil, Shaker R. ; Sloan, Jeff A. ; Barton, Debra ; Atherton, Pamela J. ; Suh, Jason J. ; Griffin, Patricia C. ; Johnson, David B. ; Ali, Aneela ; Silberstein, Peter T. ; Duane, Steven F. ; Loprinzi, Charles L. / Phase III, randomized, double-blind, placebo-controlled study of long-acting methylphenidate for cancer-related fatigue : North Central Cancer Treatment Group NCCTG-N05c7 trial. In: Journal of Clinical Oncology. 2010 ; Vol. 28, No. 23. pp. 3673-3679.
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abstract = "Purpose: Fatigue is one of the most common symptoms experienced by patients with cancer. This trial was developed to evaluate the efficacy of long-acting methylphenidate for improving cancer-related fatigue and to assess its toxicities. Patients and Methods: Adults with cancer were randomly assigned in a double-blinded manner to receive methylphenidate (target dose, 54 mg/d) or placebo for 4 weeks. The Brief Fatigue Inventory was the primary outcome measure, while secondary outcome measures included a Symptom Experience Diary (SED), the Short Form-36 (SF-36) Vitality Subscale, a linear analog self-assessment, the Pittsburgh Sleep Quality Index, and the Subject Global Impression of Change. Results: In total, 148 patients were enrolled. Using an area under the serum concentration-time curve analysis, there was no evidence that methylphenidate, as compared with placebo, improved the primary end point of cancer-related fatigue in this patient population (P = .35). Comparisons of secondary end points, including clinically significant changes in quality-of-life variables and cancer-related fatigue change from baseline, were similarly negative. However, a subset analysis suggested that patients with more severe fatigue and/or with more advanced disease did have some fatigue improvement with methylphenidate (eg, in patients with stage III or IV disease, the mean improvement in usual fatigue was 19.7 with methylphenidate v 2.1 with placebo; P = .02). There was a significant difference in self-reported toxicities (SED), with increased levels of nervousness and appetite loss in the methylphenidate arm. Conclusion: This clinical trial was unable to support the primary prestudy hypothesis that the chosen long-acting methylphenidate product would decrease cancer-related fatigue.",
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T1 - Phase III, randomized, double-blind, placebo-controlled study of long-acting methylphenidate for cancer-related fatigue

T2 - North Central Cancer Treatment Group NCCTG-N05c7 trial

AU - Moraska, Amanda R.

AU - Sood, Amit

AU - Dakhil, Shaker R.

AU - Sloan, Jeff A.

AU - Barton, Debra

AU - Atherton, Pamela J.

AU - Suh, Jason J.

AU - Griffin, Patricia C.

AU - Johnson, David B.

AU - Ali, Aneela

AU - Silberstein, Peter T.

AU - Duane, Steven F.

AU - Loprinzi, Charles L.

PY - 2010/8/10

Y1 - 2010/8/10

N2 - Purpose: Fatigue is one of the most common symptoms experienced by patients with cancer. This trial was developed to evaluate the efficacy of long-acting methylphenidate for improving cancer-related fatigue and to assess its toxicities. Patients and Methods: Adults with cancer were randomly assigned in a double-blinded manner to receive methylphenidate (target dose, 54 mg/d) or placebo for 4 weeks. The Brief Fatigue Inventory was the primary outcome measure, while secondary outcome measures included a Symptom Experience Diary (SED), the Short Form-36 (SF-36) Vitality Subscale, a linear analog self-assessment, the Pittsburgh Sleep Quality Index, and the Subject Global Impression of Change. Results: In total, 148 patients were enrolled. Using an area under the serum concentration-time curve analysis, there was no evidence that methylphenidate, as compared with placebo, improved the primary end point of cancer-related fatigue in this patient population (P = .35). Comparisons of secondary end points, including clinically significant changes in quality-of-life variables and cancer-related fatigue change from baseline, were similarly negative. However, a subset analysis suggested that patients with more severe fatigue and/or with more advanced disease did have some fatigue improvement with methylphenidate (eg, in patients with stage III or IV disease, the mean improvement in usual fatigue was 19.7 with methylphenidate v 2.1 with placebo; P = .02). There was a significant difference in self-reported toxicities (SED), with increased levels of nervousness and appetite loss in the methylphenidate arm. Conclusion: This clinical trial was unable to support the primary prestudy hypothesis that the chosen long-acting methylphenidate product would decrease cancer-related fatigue.

AB - Purpose: Fatigue is one of the most common symptoms experienced by patients with cancer. This trial was developed to evaluate the efficacy of long-acting methylphenidate for improving cancer-related fatigue and to assess its toxicities. Patients and Methods: Adults with cancer were randomly assigned in a double-blinded manner to receive methylphenidate (target dose, 54 mg/d) or placebo for 4 weeks. The Brief Fatigue Inventory was the primary outcome measure, while secondary outcome measures included a Symptom Experience Diary (SED), the Short Form-36 (SF-36) Vitality Subscale, a linear analog self-assessment, the Pittsburgh Sleep Quality Index, and the Subject Global Impression of Change. Results: In total, 148 patients were enrolled. Using an area under the serum concentration-time curve analysis, there was no evidence that methylphenidate, as compared with placebo, improved the primary end point of cancer-related fatigue in this patient population (P = .35). Comparisons of secondary end points, including clinically significant changes in quality-of-life variables and cancer-related fatigue change from baseline, were similarly negative. However, a subset analysis suggested that patients with more severe fatigue and/or with more advanced disease did have some fatigue improvement with methylphenidate (eg, in patients with stage III or IV disease, the mean improvement in usual fatigue was 19.7 with methylphenidate v 2.1 with placebo; P = .02). There was a significant difference in self-reported toxicities (SED), with increased levels of nervousness and appetite loss in the methylphenidate arm. Conclusion: This clinical trial was unable to support the primary prestudy hypothesis that the chosen long-acting methylphenidate product would decrease cancer-related fatigue.

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