Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Nervous System Diseases

Behaviors and Mental Disorders

Breast Neoplasms

Fatigue

Sleep Initiation and Maintenance Disorders

Parasomnias

Sleep Disorders, Intrinsic

Dyssomnias

Sleep Wake Disorders

Mental Disorders

Psychotic Disorders

Central Nervous System Stimulants

All Drugs and Chemicals

Modafinil

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

armodafinil

Placebo Comparator

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

CBT-I

Joseph A Roscoe, PhD

This is a four-arm, randomized, controlled, clinical trial examining the efficacy of of cognitive behavioral therapy (CBT)-I and armodafinil in reducing insomnia in 226 female breast cancer patients who report sleep disturbances following completion of chemotherapy.

Treatment Protocol: CBT-I and armodafinil are being studied in a four-arm, randomized, controlled, clinical trial of 226 cancer survivors with chronic insomnia who are at least one month post treatment. The seven-week intervention is designed to determine the efficacy and acceptability of these treatment strategies in reducing insomnia in cancer survivors. Assessments will be made by questionnaires before, during, and two weeks following the study intervention. All ancillary treatments, as appropriate for control of symptoms caused by the cancer or its treatment may be administered as clinically indicated.

Withdrawal of Sleep Medications: All participants, prior to beginning the baseline data collection phase of the study, must have withdrawn from all sleep medications, including: prescription, over-the-counter, CAM and herbal remedies for at least one week prior to beginning the study.

CBT-I (Arms 3 \& 4): CBT-I will be provided on an individual basis to all patients in study Arms 3 \& 4 by a licensed clinical psychologist trained in CBT-I by Dr. Perlis. Subjects in these two study arms will receive 7 weeks of CBT-I, using a structured research grade protocol developed at the UR-SNRL. This manualized intervention, which exists as a published text: Perlis et al., 2005, includes four essential components: Sleep Restriction Therapy, Stimulus Control Instruction, Sleep Hygiene Guidelines, and a session of cognitive therapy.

Data Collection: Patients will complete the Insomnia Severity (ISI) at the time of consent and every Friday during weeks 3-11 of the study. A follow-up call by study personnel will be made to each participant not currently receiving CBT-I on each of these Fridays to promote compliance, prompt completion, assess potential side effects of study medication, and answer patient questions.

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

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.

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.

National Cancer Institute (NCI)

University of Rochester

Research Associate Professor

Placebo Comparator: Placebo for 47 days

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

Arm 1 - (CBT-I) + Placebo

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)

2 - CBT-I + Armodafinil

3- Placebo Only

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

4 - Armodafinil Only

CBT-I and placebo

Placebo Comparator: Placebo for 47 days

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

1 - CBT-I + Placebo

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

3 - Placebo Only

Armodafinil only

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

Total

Age, Continuous

Gender

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Joseph A. Roscoe Ph.D.

Change in Insomnia Severity Index From Baseline to Post-intervention

Note: One patient randomized to the placebo only condition failed to provide data and was not included in the analyses.

Fatigue Will be Assessed by the Total Score of the Revised Brief Fatigue Inventory (BFI) .

Overall Study

Blood and Lymph Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Neoplasms by Histologic Type

Hematologic Diseases

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Myeloid Leukemia

Chronic Graft Versus Host Disease

Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

Antineoplastic Agents

Nilotinib

Dasatinib

Imatinib Mesylate

Patients randomized to nonintervention will take a placebo every morning for 2 weeks.

Three 50 mg tablets orally every morning for 2 weeks.

Placebo

Armodafinil

Carmen Escalante, MD

The goal of this clinical research study is to learn if Nuvigil (armodafinil) can help to control fatigue in patients with CML. The safety of this drug will also be studied.

The Study Drug:

Armodafinil is designed to help promote wakefulness in patients suffering from fatigue.

Study Groups:

If you are found to be eligible to take part in this study, you will take 3 tablets each day during Weeks 1, 2, 4, and 5. You will not take any tablets during Week 3.

You will be randomly assigned (as in the flip of a coin) to a study group. The tablets you receive will depend on which study group you are in. You will have an equal chance of being assigned to either group:

* If you are in Group 1, you will take armodafinil during Weeks 1 and 2 and a placebo during Weeks 4 and 5. A placebo is a tablet that looks like the study drug but has no active ingredients.
* If you are in Group 2, you will take a placebo during Weeks 1 and 2 and armodafinil during Weeks 4 and 5.

Neither you nor the study staff will know to which group you are assigned. However, if needed for your safety, the study staff will be able to find out what you are receiving at any time.

You will be given a fatigue diary and a drug diary. You will fill out the fatigue diary every day by answering 2 questions about fatigue. You will fill out the drug diary every day by writing when you take the study drug/placebo. You will return any unused drug/placebo at the end of Weeks 2 and 5.

At Week 5, you will be asked if you preferred the first period (Weeks 1 and 2 of the study) or the second period (Weeks 4 and 5 of the study). If your doctor thinks it is in your best interest and you are benefitting at this point, you will be able to continue taking the study drug and you will have additional study visits.

If you are one of the patients selected for the PK testing, the final results of the PK testing for your entire group will need to be completed before you can start the long term use of the study drug. If you take the study drug after Week 5, you will take 3 tablets every day for the rest of the time that you take the study drug.

Study Visits:

At the end of Weeks 1, 3, and 4:

* You will be asked about any symptoms that you may be having and about any other drugs that you may be taking.
* You will complete 2 questionnaires about fatigue and activity. It will take about 10 minutes to complete these questionnaires.
* Your blood pressure will be measured (Weeks 1 and 4 only).

At the end of Weeks 2 and 5:

* You will have a physical exam, including measurement of your weight and vital signs.
* You will complete the same questionnaires you completed at screening.
* Blood (about 1 teaspoon) will be drawn for routine tests.
* If you were selected for PK testing during screening, you will also have PK blood samples drawn at the end of Week 2 and Week 5.
* You will complete the series of tests that check your memory, motor skills, and thinking that you completed at screening.

At Weeks 10, 15, 20, and 25:

* You will be asked about any symptoms that you may be having and about any other drugs that you may be taking.
* You will complete the 2 questionnaires about fatigue and activity.
* Your blood pressure will be measured.

If you are not scheduled to come to MD Anderson at Weeks 1, 3, 4, 10, 15, 20, and 25, the procedures to be performed at these times can be performed at home. You will be called and asked the questions described in these visits. You will take 2 separate blood pressure measurements 5 minutes apart for each day and report results to the research staff over the telephone. If you choose to take your blood pressure measurements at home, you will be provided with a home blood pressure monitor at screening and taught how to use it. The monitor will be returned to study staff at the end of the study.

Length of Study:

You may continue taking the study drug as part of this study for up to 24 weeks. If you are benefiting after 24 weeks, you may continue taking the study drug off study. If you are one of the patients selected for the PK testing, the final results of the PK testing for your entire group will need to be completed before you can start the long term use of the study drug. You will be taken off study at any time if you have intolerable side effects or if the study doctor thinks it is in your best interest.

End of Treatment:

About 6 months after the end of Week 5, the following tests and procedures will be performed:

* You will complete the same questionnaires you completed at screening.
* You will complete the series of tests that check your memory, motor skills, and thinking that you completed at screening.
* Blood (about 1 teaspoon) will be drawn for routine tests.
* You will have a physical exam, including measurement of your weight and vital signs.

Follow-Up:

The study staff will call you about 30 days after your last dose of study drug and ask about any symptoms or complaints you may have had, as well as about any other drugs you may be taking. This call will last about 10 minutes.

This is an investigational study. Armodafinil is FDA approved and commercially available to help improve wakefulness in adults who experience excessive sleepiness. Its use in cancer-related fatigue is investigational.

Up to 60 patients will take part in this study. All will be enrolled at MD Anderson.

Nuvigil in Treatment of Cancer-Related Fatigue in Chronic Myeloid Leukemia Patients

Nuvigil in Treatment of Cancer-Related Fatigue in Chronic Myeloid Leukemia (CML) on Imatinib, Dasatinib, Nilotinib (or Any Other FDA Approved TKI for CML)

Efficacy defined by "fatigue worst" score from the Brief Fatigue Inventory (BFI) after each 2-week treatment period, using a 0 - 10 scale with 10 being WORST level of fatigue.

Cephalon

M.D. Anderson Cancer Center

Armodafinil Three 50 mg tablets orally every morning for 2 weeks.

<=18 years

Between 18 and 65 years

>=65 years

Age, Categorical

Female

Male

Carmen Escalante, MD / Chair, General Internal Medicine

No analysis completed, study stopped due to slow accrual with only one participant.

Number of Participants With "Fatigue Worst" BFI Score

Heart and Blood Diseases

Immune System Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Quality of Life

The patients receive armodafinil for all 56 days of the study.

These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).

Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets.

Placebo taken at 150 mg daily. Taken orally as three 50 mg tablets.

James Berenson, MD

The purpose of this study is to evaluate the efficacy of armodafinil for the treatment of cancer-related fatigue in adult patients with multiple myeloma. The study consists of a screening period, followed by a 56-day treatment phase, and a final assessment to occur 28 days after the end of the last treatment.

This is a Phase III, multi-center, double-blind, randomized, placebo-controlled, crossover study to evaluate the efficacy of armodafinil at a dosage of 150 mg/day for the treatment of cancer-related fatigue (CRF) in adult patients with multiple myeloma. The study consists of a screening period, followed by a 56 day treatment phase, and a final assessment to occur 28 days after the end of the last treatment.

The screening period will occur within 14 days before baseline, where "baseline" refers to day 1 when assessments will be made before drug administration. During this period, a medical history will be obtained along with a complete physical examination including vital sign measurements and Eastern Cooperative Oncology Group (ECOG) performance status. Clinical laboratory tests including hematology, clinical chemistry (blood urea nitrogen \[BUN\], serum creatinine, total bilirubin, alkaline phosphatase, aspartate aminotransferase \[AST\] and alanine aminotransferase \[ALT\]), electrolytes (potassium, sodium, chloride and calcium), random glucose, total protein, albumin, and urinalysis will also be performed during the screening period as well as serum pregnancy tests for women of childbearing potential.

During the screening period, patients will also be assessed for the presence of cancer-related fatigue using the International Classification for Disease Tenth Edition (ICD-10) diagnostic criteria and the Brief Fatigue Inventory (BFI). Only those patients showing evidence of cancer-related fatigue will be enrolled in the study. The criteria for inclusion for any given patient consist of meeting the International Classification for Disease Tenth Edition (ICD-10) criteria for cancer-related fatigue and a score ≥ 4 on the BFI. ICD-10 CRF classification will be established using a standard interview guide.

Patients eligible for the study will be randomized to either receive armodafinil at an initial fixed dosage of 150 mg/day (Group A) or a placebo (Group B) during the first 28 days of the treatment phase. On day 29, patients randomized to receive placebo will then cross over to receive armodafinil at a dosage of 150 mg/day until day 56. Group A patients randomized to receive armodafinil will continue their current treatment with the drug until day 56. The duration of the treatment phase is 56 days.

Assessments for CRF will be conducted on day 1 (baseline) prior to drug treatment, and after drug administration on days 15, 28, 43, and 56. These assessments will be conducted as verbal interviews, paper-and-pencil surveys, paper-and-pencil tests, and electronic tests as appropriate per assessment.

During the treatment phase, each patient will also have clinical laboratory tests performed on days 1, 15, 28, 43 and 56 to monitor for potential toxicity. Additional procedures performed at these visits will include monitoring for adverse events, review of concomitant medications and other support therapies (e.g., growth factors and transfusion), ECOG performance status, vital signs measurements, and physical examinations.

Twenty-eight days after the last dose of study drug, patients are to complete a final assessment (herein referred to as the end-of-treatment visit). Procedures to be conducted at this visit include measurement of vital signs, a complete physical examination, assessment of adverse events, a review of concomitant medications, assessment of ECOG performance status, hematology and clinical chemistry laboratory tests including electrolytes, total protein and albumin. Patients who withdraw from the study before the completion of the 56 day cycle will still have all end-of-treatment assessments performed 28 days after their last dose of study drug.

A Study of the Effectiveness of Armodafinil to Treat Cancer-Related Fatigue in Patients With Multiple Myeloma

A Phase III Study of Armodafinil for the Treatment of Cancer-Related Fatigue for Patients With Multiple Myeloma

Survey measuring fatigue. The scale contains 9 items; range=0-90 (0-10 per item). Mild = 1-3 Moderate = 4-7 Severe = 8-10

Cognitive test that gives a measure of various aspects of cognitive performance. Used to measure cognitive fatigue. The test consists of 25 circles containing 13 sequential numbers (1-13) and 12 sequential letters (A-L) positioned.

The test evaluates the time to correctly order letters and numbers; low times = better performance.

Test to evaluate neurocognitive functions (attention, visual scanning and motor speed). The test consists of a key =9 graphic symbols numbered 1 to 9 and the test =120 graphic symbols to be matched with its number. The test evaluates the number of correct matches within 90 seconds. Higher scores= better performance

Test evaluates working memory and attention. The test consists of repeat numeric sequences of 2 to 9 numbers forward or backwards and evaluates the number of items from a sequence correctly named. Higher scores = better performance.

Survey addressing fatigue and patient happiness, coping, etc. Used to assess quality of life. The test consists of 40 items, each item with a response scale of 0-4. Higher scores denote better status Items are added to provide the total score (range 0-160).

Survey used to assess depression and anxiety. The test consists of 14 items (7 for anxiety and 7 for depression); there are 4 possible answers for each statement. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Higher scores= more anxiety or depression.

Survey assessing sleep patterns. The test consists of 8 items. The response scale range is 0-24 (range 0-3 per item: 0-No chance to falling asleep; 3-high chance of falling asleep). Interpretation: 0-No chance to falling asleep; 10+ above average chance daytime sleepiness

Oncotherapeutics

The patients receive armodafinil for all 56 days of the study.

Armodafinil taken orally at 150 mg daily. All patients receiving armodafinil, including patients that crossover, were evaluated for adverse events (AEs) and serious adverse events (SAEs).

These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).

Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily.

AEs presented were those occurring during from Day 1 to Day 28 only

Placebo-First

The patients receive armodafinil for all 56 days of the study.

armodafinil: Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets.

These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).

armodafinil: Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets.

Placebo: Placebo taken at 150 mg daily. Taken orally as three 50 mg tablets.

Sex: Female, Male

Grade ECOG Performance status

0 Fully active, performance without restriction

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair
5. Dead

ECOG (Eastern Cooperative Oncology Group)

BFI scale: 9 items; range=0-90 (0-10 per item) Mild = 1-3 Moderate = 4-7 Severe = 8-10

Fatigue (baseline)-Brief Fatigue Inventory (BFI)

ICD-10 Criteria (Range: 0-14) A1-A11 Fatigue Criteria B. Clinically significant distress or impaired functioning C. Symptoms are a consequence of cancer or cancer therapy D. Symptoms are a consequence of comorbid psychiatric disorders

Fatigue (baseline)-International Classification of Diseases version 10 (ICD-10)

Director of Clinical Operations

Comparison between arms at Day 28 of treatment

Comparison between Day 28 and Day 56 of treatment for the armodafinil arm

Day 1(n=18, 23)

Day 28 (n=19, 23)

Day 56 (n=15)

The patients receive armodafinil for all 56 days of the study.

Armodafinil taken orally at 150 mg daily.

These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).

Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily.

BFI Score

Day 1 vs. Day 28 of treatment for the Placebo-First arm

Day 1 vs. Day 28 of treatment for the Armodafinil arm

Comparison between Day 28 and Day 56 of treatment for the Armodafinil arm

Trail Making Test B Score (TMT-B)

Day 28 vs. Day 56 of treatment for the Armodafinil arm

Symbol Digit Modalities Test Score (SDMT)

Comparison between arms at Day 28 of treatment for the Digit Span Test score-Forward test

Comparison between arms at Day 28 of treatment for the Digit Span Test score-Backward test

Day 1 vs. Day 28 of treatment for the Placebo-First arm-Digit Span Test score Forward test

Day 1 vs. Day 28 of treatment for the Placebo-First arm-Digit Span Test score Backward test

Day 1 vs. day 28 of treatment for the Armodafinil arm-Digit Span Test score-Forward test

Day 1 vs. day 28 of treatment for the Armodafinil arm-Digit Span Test score-Backward test

Day 28 vs. day 56 of treatment for the Armodafinil arm-Digit Span Test score-Forward test

Day 28 vs. day 56 of treatment for the Armodafinil arm-Digit Span Test score-Backward test

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy	NCT01091974	Insomnia Fatigue Breast Cancer	armodafinil Placebo Compara... CBT-I	21 Years - 75 Years	University of Rochester
Nuvigil in Treatment of Cancer-Related Fatigue in Chronic Myeloid Leukemia Patients	NCT01169753	Chronic Myeloid...	Placebo Armodafinil	18 Years -	M.D. Anderson Cancer Center
A Study of the Effectiveness of Armodafinil to Treat Cancer-Related Fatigue in Patients With Multiple Myeloma	NCT01160380	Fatigue Multiple Myelom...	armodafinil Placebo	18 Years -	Oncotherapeutics
Evaluate the Efficacy of Armodafinil for Patients With B-cell Lymphoma and Severe Fatigue	NCT01044004	B-cell Lymphoma Fatigue	Armodafinil placebo Armodafinil placebo	18 Years -	Washington University School of Medicine
A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas	NCT00766467	Malignant Gliom...	Armodafinil Placebo	18 Years -	Dana-Farber Cancer Institute
A Phase II Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Esophageal Cancer	NCT01746043	Esophageal Canc...	Armodafinil Placebo Minocycline Questionnaires	18 Years -	M.D. Anderson Cancer Center
A Study of the Effectiveness of Armodafinil to Treat Cancer-Related Fatigue in Patients With Multiple Myeloma	NCT01160380	Fatigue Multiple Myelom...	armodafinil Placebo	18 Years -	Oncotherapeutics
A Phase II Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Esophageal Cancer	NCT01746043	Esophageal Canc...	Armodafinil Placebo Minocycline Questionnaires	18 Years -	M.D. Anderson Cancer Center
Symptom Burden in Head and Neck Cancer	NCT01219673	Head And Neck C...	Placebo Armodafinil Minocycline Bupropion	18 Years - 65 Years	M.D. Anderson Cancer Center
Evaluate the Efficacy of Armodafinil for Patients With B-cell Lymphoma and Severe Fatigue	NCT01044004	B-cell Lymphoma Fatigue	Armodafinil placebo Armodafinil placebo	18 Years -	Washington University School of Medicine
Reducing Symptom Burden - Non Small Cell Lung Cancer (NSCLC)	NCT01048983	Non Small Cell ...	Armodafinil Bupropion Minocycline Curcumin Telephone Quest...	18 Years - 65 Years	M.D. Anderson Cancer Center
A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas	NCT00766467	Malignant Gliom...	Armodafinil Placebo	18 Years -	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for armodafinil

Every month we try and update this database with for armodafinil cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for armodafinil

Every month we try and update this database with for armodafinil cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for armodafinil cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.