ClinicalTrials.gov
ClinicalTrials.gov Menu

Management of Insomnia in Breast Cancer Patients

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: 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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title BBT-I + Armodafinil Behavioral Placebo + Armodafinil BBT-I Without Armodafinil Behavioral Placebo Without Armodafinil
Hide 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
Arm/Group Title BBT-I + Armodafinil Behavioral Placebo + Armodafinil BBT-I Without Armodafinil Behavioral Placebo Without Armodafinil Total
Hide 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
Hide 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
9 9 26 26 70
1.Primary Outcome
Title Insomnia Severity Index (ISI)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
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
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
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
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
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)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
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
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
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
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
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)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
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
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
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
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
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)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
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
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
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
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
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.
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
Hide 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%)    
Show Serious Adverse Events Hide 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
Show Other (Not Including Serious) Adverse Events Hide 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
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
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