Management of Insomnia in Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT01011218

Recruitment Status : Completed

First Posted : November 11, 2009

Results First Posted : October 9, 2018

Last Update Posted : November 29, 2018

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Oxana Palesh, Stanford University

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Supportive Care
Conditions	Insomnia Fatigue
Interventions	Behavioral: BBT-I Behavioral: Control Drug: Armodafinil
Enrollment	70

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	BBT-I + Armodafinil	Behavioral Placebo + Armodafinil	BBT-I Without Armodafinil	Behavioral Placebo Without Armodafinil
Arm/Group Description	Two Brief Behavioral Therapy for In...	Control behavioral intervention is ...	Two Brief Behavioral Therapy for In...	Control behavioral intervention is ...
Arm/Group Description	Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. Armodafinil 150 mg/day by mouth. BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(−)-enantiomer of the racemic modafinil.	Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil 150 mg/day by mouth. Control: Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(−)-enantiomer of the racemic modafinil.	Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. No pharmaceutical intervention. BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone	Control behavioral intervention is a sleep hygiene handout completed by participant. No pharmaceutical intervention. Control: Control behavioral intervention is a sleep hygiene handout completed by participant.
Period Title: Overall Study
Started	9	9	26	26
Completed	9	9	26	26
Not Completed	0	0	0	0

Baseline Characteristics

Arm/Group Title		BBT-I + Armodafinil	Behavioral Placebo + Armodafinil	BBT-I Without Armodafinil	Behavioral Placebo Without Armodafinil	Total
Arm/Group Description		Two Brief Behavioral Therapy for In...	Control behavioral intervention is ...	Two Brief Behavioral Therapy for In...	Control behavioral intervention is ...	Total of all reporting groups
Arm/Group Description		Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. Armodafinil 150 mg/day by mouth. BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(−)-enantiomer of the racemic modafinil.	Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil 150 mg/day by mouth. Control: Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(−)-enantiomer of the racemic modafinil.	Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. No pharmaceutical intervention. BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone	Control behavioral intervention is a sleep hygiene handout completed by participant. No pharmaceutical intervention. Control: Control behavioral intervention is a sleep hygiene handout completed by participant.	Total of all reporting groups
Overall Number of Baseline Participants		9	9	26	26	70
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	9 participants	9 participants	26 participants	26 participants	70 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	9 100.0%	9 100.0%	23 88.5%	24 92.3%	65 92.9%
	>=65 years	0 0.0%	0 0.0%	3 11.5%	2 7.7%	5 7.1%
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	9 participants	9 participants	26 participants	26 participants	70 participants
		49.1 (10.5)	46.7 (9.2)	51.5 (9.0)	50.3 (8.6)	50.1 (9.0)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	9 participants	9 participants	26 participants	26 participants	70 participants
	Female	9 100.0%	9 100.0%	26 100.0%	26 100.0%	70 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	9 participants	9 participants	26 participants	26 participants	70 participants
	Hispanic or Latino	3 33.3%	1 11.1%	4 15.4%	6 23.1%	14 20.0%
	Not Hispanic or Latino	1 11.1%	4 44.4%	17 65.4%	11 42.3%	33 47.1%
	Unknown or Not Reported	5 55.6%	4 44.4%	5 19.2%	9 34.6%	23 32.9%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	9 participants	9 participants	26 participants	26 participants	70 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	2 7.7%	2 2.9%
	Asian	0 0.0%	0 0.0%	5 19.2%	4 15.4%	9 12.9%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	2 7.7%	0 0.0%	2 2.9%
	Black or African American	0 0.0%	0 0.0%	2 7.7%	1 3.8%	3 4.3%
	White	8 88.9%	8 88.9%	14 53.8%	16 61.5%	46 65.7%
	More than one race	1 11.1%	1 11.1%	3 11.5%	3 11.5%	8 11.4%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	9 participants	9 participants	26 participants	26 participants	70 participants
United States		9	9	26	26	70

Outcome Measures

1.Primary Outcome

Title	Insomnia Severity Index (ISI)
Description	Insomnia Severity Index ...
Description	Insomnia Severity Index (ISI) survey questionnaire is a 7-question survey, with each question having 5 possible answers (none, mild, moderate, severe, or very severe), scored as 0, 1, 2, 3, or 4, respectively. The full range of ISI scores is from 0 to 28. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater insomnia. Clinical interpretation is as follows. 0 to 7 No clinically significant insomnia 8 to14 Subthreshold insomnia 15 to 21 Clinical insomnia (moderate severity) 22 to 28 Clinical insomnia (severe) ISI survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean ISI score with standard deviation.
Time Frame	up to 32 Weeks

Outcome Measure Data

Analysis Population Description

After baseline, it was not uncommon for participants to not contribute data for every time point.


Arm/Group Title		BBT-I + Armodafinil	Behavioral Placebo + Armodafinil	BBT-I Without Armodafinil	Behavioral Placebo Without Armodafinil
Arm/Group Description:		Two Brief Behavioral Therapy for In...	Control behavioral intervention is ...	Two Brief Behavioral Therapy for In...	Control behavioral intervention is ...
Arm/Group Description:		Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. Armodafinil 150 mg/day by mouth. BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(−)-enantiomer of the racemic modafinil.	Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil 150 mg/day by mouth. Control: Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(−)-enantiomer of the racemic modafinil.	Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. No pharmaceutical intervention. BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone	Control behavioral intervention is a sleep hygiene handout completed by participant. No pharmaceutical intervention. Control: Control behavioral intervention is a sleep hygiene handout completed by participant.
Overall Number of Participants Analyzed		9	9	26	26
Mean (Standard Deviation) Unit of Measure: units on a scale
Baseline	Number Analyzed	9 participants	9 participants	26 participants	26 participants
Baseline		16.3 (7.4)	14.6 (6.3)	13.5 (5.2)	12.1 (5.4)
3 Weeks	Number Analyzed	2 participants	9 participants	23 participants	22 participants
3 Weeks		13.0 (7.1)	10.8 (6.5)	11.4 (7.1)	12.3 (4.9)
6 Weeks	Number Analyzed	6 participants	9 participants	25 participants	24 participants
6 Weeks		9 (6.1)	10 (6.9)	8.0 (5.7)	10.5 (6.5)
10 Weeks	Number Analyzed	4 participants	9 participants	24 participants	23 participants
10 Weeks		6.0 (3.6)	8.3 (5.6)	7.8 (4.5)	10.6 (6.2)
32 Weeks	Number Analyzed	1 participants	9 participants	14 participants	16 participants
32 Weeks		3.0 ^[1] (NA)	7.6 (4.4)	7.0 (4.6)	8.1 (6.3)

[1]

Cannot generate standard deviation on single value.

2.Secondary Outcome

Title	Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Description	The Functional Assessmen...
Description	The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) survey questionnaire is a 13-question subset of the 41-question Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire, with each question having 5 possible answers (not at all; a little bit; somewhat; quite a bit; very much), scored as 0, 1, 2, 3, or 4, respectively. The full range of FACIT-Fatigue scores is from 0 to 52. Higher scores are considered good, better, or healthy, and increasingly lower scores are considered to indicate greater fatigue. The FACIT-Fatigue survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean with standard deviation.
Time Frame	up to 32 Weeks

Outcome Measure Data

Analysis Population Description

After baseline, it was not uncommon for participants to not contribute data for every time point.


Arm/Group Title		BBT-I + Armodafinil	Behavioral Placebo + Armodafinil	BBT-I Without Armodafinil	Behavioral Placebo Without Armodafinil
Arm/Group Description:		Two Brief Behavioral Therapy for In...	Control behavioral intervention is ...	Two Brief Behavioral Therapy for In...	Control behavioral intervention is ...
Arm/Group Description:		Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. Armodafinil 150 mg/day by mouth. BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(−)-enantiomer of the racemic modafinil.	Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil 150 mg/day by mouth. Control: Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(−)-enantiomer of the racemic modafinil.	Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. No pharmaceutical intervention. BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone	Control behavioral intervention is a sleep hygiene handout completed by participant. No pharmaceutical intervention. Control: Control behavioral intervention is a sleep hygiene handout completed by participant.
Overall Number of Participants Analyzed		9	9	26	26
Mean (Standard Deviation) Unit of Measure: units on a scale
Baseline	Number Analyzed	9 participants	9 participants	26 participants	26 participants
Baseline		27.2 (27.3)	29.1 (8.2)	29.1 (12.2)	30.3 (11.5)
3 Weeks	Number Analyzed	6 participants	9 participants	25 participants	25 participants
3 Weeks		33.5 (12.5)	29.6 (10.2)	29.4 (11.3)	31.0 (11.5)
6 Weeks	Number Analyzed	6 participants	9 participants	25 participants	24 participants
6 Weeks		32.5 (10.6)	33.7 (11.4)	33.1 (12.4)	34.2 (11.7)
10 Weeks	Number Analyzed	4 participants	8 participants	24 participants	23 participants
10 Weeks		41.5 (10.0)	34.2 (12.7)	33.2 (11.5)	34.5 (13.8)
32 Weeks	Number Analyzed	1 participants	5 participants	14 participants	16 participants
32 Weeks		51 ^[1] (NA)	35.8 (4.32)	37.9 (11.9)	35.9 (10.8)

[1]

Standard deviation cannot be generated from a single value.

3.Other Pre-specified Outcome

Title	The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Description	The full Functional Asse...
Description	The full Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) survey questionnaire is a 41-question survey, with each question having 5 possible answers (not at all; a little bit; somewhat; quite a bit; very much), scored as 0, 1, 2, 3, or 4, respectively. The full range of scores is from 0 to 164. Higher scores are considered good, better, or healthy, and increasingly lower scores are considered to indicate greater fatigue. The FACIT-F survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean with standard deviation.
Time Frame	up to 32 Weeks

Outcome Measure Data

Analysis Population Description

After baseline, it was not uncommon for participants to not contribute data for every time point.


Arm/Group Title		BBT-I + Armodafinil	Behavioral Placebo + Armodafinil	BBT-I Without Armodafinil	Behavioral Placebo Without Armodafinil
Arm/Group Description:		Two Brief Behavioral Therapy for In...	Control behavioral intervention is ...	Two Brief Behavioral Therapy for In...	Control behavioral intervention is ...
Arm/Group Description:		Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. Armodafinil 150 mg/day by mouth. BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(−)-enantiomer of the racemic modafinil.	Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil 150 mg/day by mouth. Control: Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(−)-enantiomer of the racemic modafinil.	Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. No pharmaceutical intervention. BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone	Control behavioral intervention is a sleep hygiene handout completed by participant. No pharmaceutical intervention. Control: Control behavioral intervention is a sleep hygiene handout completed by participant.
Overall Number of Participants Analyzed		9	9	26	26
Mean (Standard Deviation) Unit of Measure: units on a scale
Baseline	Number Analyzed	9 participants	9 participants	26 participants	26 participants
Baseline		99.3 (32.0)	101.2 (21.6)	100.0 (26.2)	103.0 (24.4)
3 Weeks	Number Analyzed	6 participants	9 participants	26 participants	25 participants
3 Weeks		109.8 (25.8)	99.2 (26.8)	101.8 (27.3)	103.3 (29.5)
6 Weeks	Number Analyzed	6 participants	9 participants	26 participants	24 participants
6 Weeks		110.8 (24.1)	106.3 (25.8)	106.4 (31.6)	108.1 (26.6)
10 Weeks	Number Analyzed	4 participants	9 participants	26 participants	23 participants
10 Weeks		125.5 (21.6)	111.2 (29.6)	107.3 (26.9)	107.9 (32.0)
32 Weeks	Number Analyzed	1 participants	9 participants	26 participants	16 participants
32 Weeks		155 ^[1] (NA)	118.2 (11.9)	118.1 (29.2)	116.4 (23.4)

[1]

Standard deviation cannot be generated from a single value.

4.Other Pre-specified Outcome

Title	Brief Fatigue Inventory (BFI)
Description	The Brief Fatigue Invent...
Description	The Brief Fatigue Inventory (BFI) survey questionnaire is a 9-question survey, with each question having 11 possible answers ("No fatigue" to "As bad as you can imagine"), scored from 0 to 10, with each patient's overall BFI score being the mean of the values from each question (overall range 0 to 10). Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater fatigue. The BFI survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean of the overall BFI scores with standard deviation.
Time Frame	up to 32 Weeks

Outcome Measure Data

Analysis Population Description

After baseline, it was not uncommon for participants to not contribute data for every time point.


Arm/Group Title		BBT-I + Armodafinil	Behavioral Placebo + Armodafinil	BBT-I Without Armodafinil	Behavioral Placebo Without Armodafinil
Arm/Group Description:		Two Brief Behavioral Therapy for In...	Control behavioral intervention is ...	Two Brief Behavioral Therapy for In...	Control behavioral intervention is ...
Arm/Group Description:		Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. Armodafinil 150 mg/day by mouth. BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(−)-enantiomer of the racemic modafinil.	Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil 150 mg/day by mouth. Control: Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(−)-enantiomer of the racemic modafinil.	Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. No pharmaceutical intervention. BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone	Control behavioral intervention is a sleep hygiene handout completed by participant. No pharmaceutical intervention. Control: Control behavioral intervention is a sleep hygiene handout completed by participant.
Overall Number of Participants Analyzed		9	9	26	26
Mean (Standard Deviation) Unit of Measure: units on a scale
Baseline	Number Analyzed	9 participants	9 participants	26 participants	26 participants
Baseline		5.5 (2.6)	5.2 (2.0)	4.4 (2.7)	4.1 (2.4)
3 Weeks	Number Analyzed	6 participants	9 participants	25 participants	25 participants
3 Weeks		2.8 (1.9)	4.2 (2.5)	4.4 (2.8)	4.0 (2.5)
6 Weeks	Number Analyzed	6 participants	9 participants	25 participants	24 participants
6 Weeks		4.0 (2.5)	3.8 (2.5)	3.0 (2.4)	3.4 (2.3)
10 Weeks	Number Analyzed	4 participants	9 participants	24 participants	23 participants
10 Weeks		2.5 (2.2)	3.1 (2.2)	3.1 (2.2)	3.4 (2.6)
32 Weeks	Number Analyzed	1 participants	9 participants	14 participants	16 participants
32 Weeks		1.0 ^[1] (NA)	3.6 (2.0)	2.7 (2.3)	3.6 (2.6)

[1]

Standard deviation cannot be generated from a single value.

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	BBT-I + Armodafinil		Behavioral Placebo + Armodafinil		BBT-I Without Armodafinil		Behavioral Placebo Without Armodafinil
Arm/Group Description	Two Brief Behavioral Therapy for In...		Control behavioral intervention is ...		Two Brief Behavioral Therapy for In...		Control behavioral intervention is ...
Arm/Group Description	Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. Armodafinil 150 mg/day by mouth. BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(−)-enantiomer of the racemic modafinil.		Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil 150 mg/day by mouth. Control: Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(−)-enantiomer of the racemic modafinil.		Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. No pharmaceutical intervention. BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone		Control behavioral intervention is a sleep hygiene handout completed by participant. No pharmaceutical intervention. Control: Control behavioral intervention is a sleep hygiene handout completed by participant.
All-Cause Mortality
	BBT-I + Armodafinil		Behavioral Placebo + Armodafinil		BBT-I Without Armodafinil		Behavioral Placebo Without Armodafinil
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	0/9 (0.00%)		1/9 (11.11%)		1/26 (3.85%)		1/26 (3.85%)
Serious Adverse Events Serious Adverse Events
	BBT-I + Armodafinil		Behavioral Placebo + Armodafinil		BBT-I Without Armodafinil		Behavioral Placebo Without Armodafinil
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/9 (11.11%)		1/9 (11.11%)		1/26 (3.85%)		1/26 (3.85%)
General disorders
Death, not otherwise specified ^† 1	0/9 (0.00%)	0	1/9 (11.11%)	1	1/26 (3.85%)	1	1/26 (3.85%)	1
Musculoskeletal and connective tissue disorders
Pain, bone ^† 1	1/9 (11.11%)	1	0/9 (0.00%)	0	0/26 (0.00%)	0	0/26 (0.00%)	0
1 Term from vocabulary, CTCAE (4.0) † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	BBT-I + Armodafinil		Behavioral Placebo + Armodafinil		BBT-I Without Armodafinil		Behavioral Placebo Without Armodafinil
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/9 (100.00%)		9/9 (100.00%)		5/26 (19.23%)		3/26 (11.54%)
Cardiac disorders
Heart rate increased ^† 1	0/9 (0.00%)	0	0/9 (0.00%)	0	1/26 (3.85%)	1	0/26 (0.00%)	0
Gastrointestinal disorders
Diarrhea ^† 1	0/9 (0.00%)	0	1/9 (11.11%)	1	0/26 (0.00%)	0	0/26 (0.00%)	0
Dry mouth ^† 1	0/9 (0.00%)	0	1/9 (11.11%)	1	0/26 (0.00%)	0	0/26 (0.00%)	0
Nausea ^† 1	1/9 (11.11%)	1	3/9 (33.33%)	3	0/26 (0.00%)	0	0/26 (0.00%)	0
Pain, abdominal ^† 1	0/9 (0.00%)	0	1/9 (11.11%)	1	0/26 (0.00%)	0	0/26 (0.00%)	0
Stomach ache ^† 1	0/9 (0.00%)	0	0/9 (0.00%)	0	1/26 (3.85%)	1	0/26 (0.00%)	0
Vomiting ^† 1	0/9 (0.00%)	0	1/9 (11.11%)	1	0/26 (0.00%)	0	0/26 (0.00%)	0
General disorders
Fatigue ^† 1	2/9 (22.22%)	2	0/9 (0.00%)	0	0/26 (0.00%)	0	0/26 (0.00%)	0
Fever ^† 1	0/9 (0.00%)	0	1/9 (11.11%)	1	0/26 (0.00%)	0	0/26 (0.00%)	0
Influenza ^† 1	0/9 (0.00%)	0	1/9 (11.11%)	1	0/26 (0.00%)	0	0/26 (0.00%)	0
Pain ^† 1	1/9 (11.11%)	1	0/9 (0.00%)	0	0/26 (0.00%)	0	0/26 (0.00%)	0
Infections and infestations
Infection, breast ^† 1	0/9 (0.00%)	0	1/9 (11.11%)	1	0/26 (0.00%)	0	0/26 (0.00%)	0
Infection, bronchial ^† 1	0/9 (0.00%)	0	0/9 (0.00%)	0	0/26 (0.00%)	0	1/26 (3.85%)	1
Infection, upper respiratory ^† 1	0/9 (0.00%)	0	0/9 (0.00%)	0	0/26 (0.00%)	0	1/26 (3.85%)	1
Nervous system disorders
Headache ^† 1	1/9 (11.11%)	1	2/9 (22.22%)	2	0/26 (0.00%)	0	0/26 (0.00%)	0
Pain, sinus ^† 1	0/9 (0.00%)	0	1/9 (11.11%)	1	0/26 (0.00%)	0	0/26 (0.00%)	0
Presyncope ^† 1	1/9 (11.11%)	1	0/9 (0.00%)	0	0/26 (0.00%)	0	0/26 (0.00%)	0
Seizure ^† 1	0/9 (0.00%)	0	0/9 (0.00%)	0	0/26 (0.00%)	0	1/26 (3.85%)	1
Psychiatric disorders
Agitation ^† 1	1/9 (11.11%)	1	1/9 (11.11%)	1	1/26 (3.85%)	1	0/26 (0.00%)	0
Anxiety ^† 1	0/9 (0.00%)	0	0/9 (0.00%)	0	1/26 (3.85%)	1	0/26 (0.00%)	0
Insomnia ^† 1	3/9 (33.33%)	3	0/9 (0.00%)	0	1/26 (3.85%)	1	0/26 (0.00%)	0
1 Term from vocabulary, CTCAE (4.0) † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title: Oxana RG Palesh, MD, PhD; Assistant Professor of Psychiatry and Behavioral Sciences

Organization: Stanford University Medical Center

Phone: 650-725-7011

EMail: oxana.palesh@stanford.edu

Responsible Party:	Oxana Palesh, Stanford University
ClinicalTrials.gov Identifier:	NCT01011218 History of Changes
Other Study ID Numbers:	IRB-17323 K07CA132916-01A1 ( U.S. NIH Grant/Contract ) 25740 ( Other Identifier: University of Rochester - old protocol ID ) BRS0008 ( Other Identifier: OnCore )
First Submitted:	November 9, 2009
First Posted:	November 11, 2009
Results First Submitted:	September 13, 2018
Results First Posted:	October 9, 2018
Last Update Posted:	November 29, 2018

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