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Trial record 53 of 239 for:    (armodafinil)

Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01091974
Recruitment Status : Completed
First Posted : March 24, 2010
Results First Posted : March 13, 2015
Last Update Posted : February 9, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Joseph Roscoe, University of Rochester

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions Insomnia
Fatigue
Breast Cancer
Interventions Drug: armodafinil
Drug: Placebo Comparator
Behavioral: CBT-I
Enrollment 138
Recruitment Details 138 Patients were consented of which 114 were eligible.
Pre-assignment Details 18 Withdrew prior to randomization (3 ceased responding to contacts, 4 changed mind , 3 began or restarted sleep medication, 4 did not complete baseline measures, 1 did not receive approval from physician to participate, 1 found the diaries too much trouble, 1 did not want to take study medication, and 1 had a family emergency).
Arm/Group Title Arm 1 - (CBT-I) + Placebo 2 - CBT-I + Armodafinil 3- Placebo Only 4 - Armodafinil Only
Hide Arm/Group Description

Placebo Comparator: Placebo for 47 days

CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)

Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)

CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)

Placebo Comparator: Placebo for 47 days Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
Period Title: Overall Study
Started 24 23 25 24
Completed 19 18 19 17
Not Completed 5 5 6 7
Reason Not Completed
Did not start intervention             3             1             3             1
resumed sleep medication             0             0             1             2
Withdrawal by Subject             1             3             2             2
side-effects             1             1             0             2
Arm/Group Title 1 - CBT-I + Placebo 2 - CBT-I + Armodafinil 3 - Placebo Only 4 - Armodafinil Only Total
Hide Arm/Group Description

CBT-I and placebo

Placebo Comparator: Placebo for 47 days

CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)

CBT-I + Armodafinil

armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)

CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)

Placebo only

Placebo Comparator: Placebo for 47 days

Armodafinil only

armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)

Total of all reporting groups
Overall Number of Baseline Participants 24 23 25 24 96
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 23 participants 25 participants 24 participants 96 participants
59  (9.9) 56  (10.2) 52  (11.5) 57  (7.4) 56.1  (10.0)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 23 participants 25 participants 24 participants 96 participants
Female
21
  87.5%
22
  95.7%
18
  72.0%
23
  95.8%
84
  87.5%
Male
3
  12.5%
1
   4.3%
7
  28.0%
1
   4.2%
12
  12.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 23 participants 25 participants 24 participants 96 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
23
  95.8%
22
  95.7%
24
  96.0%
22
  91.7%
91
  94.8%
Unknown or Not Reported
1
   4.2%
1
   4.3%
1
   4.0%
2
   8.3%
5
   5.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 23 participants 25 participants 24 participants 96 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   4.2%
2
   8.7%
4
  16.0%
1
   4.2%
8
   8.3%
White
23
  95.8%
21
  91.3%
19
  76.0%
23
  95.8%
86
  89.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
2
   8.0%
0
   0.0%
2
   2.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants 23 participants 25 participants 24 participants 96 participants
24 23 25 24 96
1.Primary Outcome
Title Change in Insomnia Severity Index From Baseline to Post-intervention
Hide Description The Insomnia Severity Index (ISI) is a commonly used, 7-item psychometrically validated measure used to rate insomnia with 0-7 = absence of insomnia, 8-14 = subthreshold insomnia symptoms, 15-21 = moderate insomnia, and 22-28 = severe insomnia.
Time Frame ANCOVA was employed with multiple imputation on the post-intervention score (average of the two post-intervention weeks), controlling for the score at the time of consent (pre).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - (CBT-I) + Placebo 2 - CBT-I + Armodafinil 3- Placebo Only 4 - Armodafinil Only
Hide Arm/Group Description:

Placebo Comparator: Placebo for 47 days

CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)

Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)

CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)

Placebo Comparator: Placebo for 47 days
Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
Overall Number of Participants Analyzed 24 23 25 24
Mean (Standard Error)
Unit of Measure: units on a scale
-4.93  (1.85) -6.36  (1.84) 1.04  (1.89) -1.43  (1.78)
2.Secondary Outcome
Title Fatigue Will be Assessed by the Total Score of the Revised Brief Fatigue Inventory (BFI) .
Hide Description The revised Brief Fatigue Inventory (BFI) is a 9-item, patient-report instrument with established reliability and validity. The BFI allows for the rapid assessment of fatigue level in cancer patients and identifies those patients with severe fatigue. Three items ask patients to rate their fatigue “now,” and fatigue at its “worst” and “usual” for the last 24 hours. The 11-point scales are bounded by 0 = “no fatigue” and 10 = “fatigue as bad as you can imagine.” Using the same type of scales, the remaining questions ask patients to rate how their fatigue interferes with several functional domains, including general activity, walking, mood, work, and relations with others. These scales are bounded by 0 = “does not interfere” and 10 = “interferes completely.” A global fatigue score (ranging from 0-10) can be obtained by averaging all the items on the BFI.
Time Frame ANCOVA was employed with multiple imputation on the post-intervention score (average of the two post-intervention weeks), controlling for the score at the time of consent (pre).
Hide Outcome Measure Data
Hide Analysis Population Description
Note: One patient randomized to the placebo only condition failed to provide data and was not included in the analyses.
Arm/Group Title Arm 1 - (CBT-I) + Placebo 2 - CBT-I + Armodafinil 3- Placebo Only 4 - Armodafinil Only
Hide Arm/Group Description:

Placebo Comparator: Placebo for 47 days

CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)

Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)

CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)

Placebo Comparator: Placebo for 47 days
Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
Overall Number of Participants Analyzed 24 23 24 24
Mean (Standard Error)
Unit of Measure: units on a scale
2.041  (0.411) 1.209  (0.364) 2.971  (0.534) 3.167  (0.456)
Time Frame Participants were followed throughout the study duration, for up to 24 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 - (CBT-I) + Placebo 2 - CBT-I + Armodafinil 3- Placebo Only 4 - Armodafinil Only
Hide Arm/Group Description

Placebo Comparator: Placebo for 47 days

CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)

Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)

CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)

Placebo Comparator: Placebo for 47 days Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
All-Cause Mortality
Arm 1 - (CBT-I) + Placebo 2 - CBT-I + Armodafinil 3- Placebo Only 4 - Armodafinil Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 - (CBT-I) + Placebo 2 - CBT-I + Armodafinil 3- Placebo Only 4 - Armodafinil Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/23 (0.00%)      0/25 (0.00%)      0/24 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1 - (CBT-I) + Placebo 2 - CBT-I + Armodafinil 3- Placebo Only 4 - Armodafinil Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      3/23 (13.04%)      0/25 (0.00%)      0/24 (0.00%)    
General disorders         
Headache *  0/24 (0.00%)  0 2/23 (8.70%)  2 0/25 (0.00%)  0 0/24 (0.00%)  0
Nervous system disorders         
Numbness/tingling *  0/24 (0.00%)  0 1/23 (4.35%)  1 0/25 (0.00%)  0 0/24 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Joseph A. Roscoe Ph.D.
Organization: University of Rochester Medical Center
Phone: (585) 275-9962
Responsible Party: Joseph Roscoe, University of Rochester
ClinicalTrials.gov Identifier: NCT01091974     History of Changes
Other Study ID Numbers: UCCS07090
1R01CA126968-01A1 ( U.S. NIH Grant/Contract )
First Submitted: December 9, 2009
First Posted: March 24, 2010
Results First Submitted: February 5, 2015
Results First Posted: March 13, 2015
Last Update Posted: February 9, 2017