PMID- 19896571
OWN - NLM
STAT- MEDLINE
DCOM- 20100125
LR  - 20220316
IS  - 1873-6513 (Electronic)
IS  - 0885-3924 (Linking)
VI  - 38
IP  - 5
DP  - 2009 Nov
TI  - Efficacy of dexmethylphenidate for the treatment of fatigue after cancer 
      chemotherapy: a randomized clinical trial.
PG  - 650-62
LID - 10.1016/j.jpainsymman.2009.03.011 [doi]
AB  - Cancer and its treatment can induce subjective and objective evidence of 
      diminished functional capacity encompassing physical fatigue and cognitive 
      impairment. Dexmethylphenidate (D-MPH; the D-isomer of methylphenidate) was 
      evaluated for treatment of chemotherapy-related fatigue and cognitive impairment. 
      A randomized, double-blind, placebo-controlled, parallel-group study evaluated 
      the potential therapeutic effect and safety of D-MPH in the treatment of patients 
      with chemotherapy-related fatigue. Change from baseline in the Functional 
      Assessment of Chronic Illness Therapy-Fatigue Subscale (FACIT-F) total score at 
      Week 8 was the primary outcome measure. One hundred fifty-four patients 
      (predominantly with breast and ovarian cancers) were randomized and treated. 
      Compared with placebo, D-MPH-treated subjects demonstrated a significant 
      improvement in fatigue symptoms at Week 8 in the FACIT-F (P=0.02) and the 
      Clinical Global Impression-Severity scores (P=0.02), without clinically relevant 
      changes in hemoglobin levels. Cognitive function was not significantly improved. 
      There was a higher rate of study drug-related adverse events (AEs) (48 of 76 
      [63%] vs. 22 of 78 [28%]) and a higher discontinuation rate because of AEs (8 of 
      76 [11%] vs. 1 of 78 [1.3%]) in D-MPH-treated subjects compared with 
      placebo-treated subjects. The most commonly reported AEs independent of study 
      drug relationship in D-MPH-treated subjects were headache, nausea, and dry mouth, 
      and in placebo-treated subjects were headache, diarrhea, and insomnia. D-MPH 
      produced significant improvement in fatigue in subjects previously treated with 
      cytotoxic chemotherapy. Further studies with D-MPH or other agents to explore 
      treatment response in chemotherapy-associated fatigue should be considered.
FAU - Lower, Elyse E
AU  - Lower EE
AD  - University of Cincinnati Medical Center, Cincinnati, Ohio 45267-0565, USA. 
      elower@ohcmail.com
FAU - Fleishman, Stewart
AU  - Fleishman S
FAU - Cooper, Alyse
AU  - Cooper A
FAU - Zeldis, Jerome
AU  - Zeldis J
FAU - Faleck, Herbert
AU  - Faleck H
FAU - Yu, Zhinuan
AU  - Yu Z
FAU - Manning, Donald
AU  - Manning D
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Pain Symptom Manage
JT  - Journal of pain and symptom management
JID - 8605836
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Central Nervous System Stimulants)
RN  - 1678OK0E08 (Dexmethylphenidate Hydrochloride)
RN  - 207ZZ9QZ49 (Methylphenidate)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Antineoplastic Agents/*adverse effects/therapeutic use
MH  - Central Nervous System Stimulants/*therapeutic use
MH  - *Dexmethylphenidate Hydrochloride
MH  - Double-Blind Method
MH  - Fatigue/*chemically induced/*drug therapy/psychology
MH  - Female
MH  - Humans
MH  - Male
MH  - Methylphenidate/*therapeutic use
MH  - Middle Aged
MH  - Neoplasms/*complications/drug therapy
MH  - Neuropsychological Tests
MH  - Sample Size
MH  - Young Adult
EDAT- 2009/11/10 06:00
MHDA- 2010/01/26 06:00
CRDT- 2009/11/10 06:00
PHST- 2008/08/21 00:00 [received]
PHST- 2009/02/26 00:00 [revised]
PHST- 2009/04/01 00:00 [accepted]
PHST- 2009/11/10 06:00 [entrez]
PHST- 2009/11/10 06:00 [pubmed]
PHST- 2010/01/26 06:00 [medline]
AID - S0885-3924(09)00729-5 [pii]
AID - 10.1016/j.jpainsymman.2009.03.011 [doi]
PST - ppublish
SO  - J Pain Symptom Manage. 2009 Nov;38(5):650-62. doi: 
      10.1016/j.jpainsymman.2009.03.011.