Conditions: Fatigue Chemotherapy Side Effects
Keywords: Cancer Fatigue Taxanes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 10
Healthy volunteers: no

Brief summary:
Evaluate the Safety and Efficacy of Armodafinil Treatment for Patients With Fatigue Associated With Taxane Chemotherapy Alone or in Combination With Other Agents

Detailed description:
The primary objective of study was to determine whether armodafinil treatment at a dose of 150 mg/day is more effective than placebo treatment in reducing fatigue in patients receiving taxane chemotherapy alone or in combination with other agents by comparing the change from Screening cycle to treatment cycle (cycle 2) in the patient's average daily rating of their worst fatigue severity during the past 24 hours. In addition, the change in the percentage of days with severe fatigue and the mean Brief Fatigue Inventory scores were to be recorded.

Arms:
arm 1: * 150 mg/day armodafinil
* taxane chemotherapy treatment alone or in combination with other agents arm 2: * placebo
* taxane chemotherapy treatment alone or in combination with other agents

Interventions: intervention 1: Armodafinil 150 mg/day intervention 2: Placebo,
Intervention descriptions: intervention 1: * 150 mg/day armodafinil
* concurrent with one cycle of taxane chemotherapy alone or in combination with other agents
* patients may then continue receiving armodafinil treatment after the double-blind treatment period by entering a 24-week open-label extension period, with continuing taxane chemotherapy alone, or in combination with other agents intervention 2: * placebo
* concurrent with one cycle of taxane chemotherapy alone or in combination with other agents
* patients may then continue receiving armodafinil treatment after the double-blind treatment period by entering a 24-week open-label extension period, with continuing taxane chemotherapy alone, or in combination with other agents

Protocol document: