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Evaluate the Efficacy of Armodafinil for Patients With B-cell Lymphoma and Severe Fatigue

Primary Purpose

B-cell Lymphoma, Fatigue

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Armodafinil

placebo

Armodafinil

placebo

About this trial

This is an interventional treatment trial for B-cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria for both arms:

Age ≥ 18 with diagnosis of B-cell lymphoma
Average score of ≥ 7 on daily worst fatigue severity assessment from the BFI questionnaire during screening
Able to demonstrate appropriate use of the wrist actigraphy device and to complete questionnaires
ECOG performance status 0-2
Laboratory values:
Hemoglobin ≥ 10 g/dL
Total Bilirubin ≤ 1.5 x institutional ULN
AST/ALT ≤ 2.5 x institutional ULN
Creatinine ≤ 1.5 x institutional ULN
Albumin ≥ 3.5 g/dl
Life expectancy > 6 months
IRB-approved informed consent form must be signed before any protocol-specific screening procedures are performed.

Inclusion criteria for patients undergoing R-CHOP chemotherapy:

Scheduled to receive 6 cycles of standard R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) chemotherapy as first-line treatment

Inclusion criteria for patients in remission following chemotherapy and/or radiotherapy:

May have received one prior regimen of chemotherapy and/or radiotherapy
Adequate response to upfront chemotherapy and/or radiotherapy
Indolent lymphomas - must have achieved a partial or complete response with no immediate plans for further treatment
Aggressive lymphomas - must have achieved a complete response:
- ≥ 4 weeks since completion of chemotherapy
- ≥ 8 weeks since completion of radiotherapy
- ≤ 18 months since completion of chemotherapy or radiotherapy

Exclusion Criteria for both arms:

Uncontrolled medical and/or psychiatric condition that may cause fatigue or that the PI feels is clinically significant and might adversely affect patient safety (such as sleep disorders, moderate/severe depression, metabolic/endocrine abnormalities, infections)
History of clinically significant cardiac disorders, such as left ventricular hypertrophy or mitral valve prolapse experienced in conjunction with receiving CNS stimulants
History of serious skin reactions, such as serious rash or Stevens-Johnson Syndrome
Concurrent stimulant medication
Any other active malignancy within the past 3 years except cervical carcinoma in situ and non-melanoma skin cancers
Known CNS involvement by lymphoma
Cachexia
Use of opioids at time of randomization
Known sensitivity to modafinil and/or armodafinil

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Post treatment remission armodafinil

Post treatment remission placebo

Chemotherapy armodafinil

Chemotherapy placebo

Arm Description

Armodafinil 150 mg/day for 13 weeks

Placebo 150mg/day for 13 weeks

Armodafinil 150 mg/day for 13 weeks

Placebo 150mg/day for 13 weeks

Outcomes

Primary Outcome Measures

To determine whether armodafinil is more effective than placebo in reducing fatigue as measured by the change in scores from the FACT-Fatigue reported at study entry, week 7 of study treatment, and study completion (week 13).

Secondary Outcome Measures

To determine whether armodafinil is more effective than placebo in improving work quality as measured by the change in scores from the WLQ© reported at study entry (week 1) and study completion (week 13).

To determine whether armodafinil is more effective than placebo in reducing fatigue as measured by standard actigraphy summary statistics will be done at week 1 of screening, week 7 of study treatment, and study completion (week 13).

To determine whether armodafinil is more effective than placebo in reducing fatigue as measured by actigraphy using applied functional data analysis during week 1 of screening, week 7 of study treatment, and study completion (week 13).

To evaluate whether measured cytokines (IL-2, IL-6, IL-10, TNF-α, and TGF-α) are elevated at baseline.

To evaluate whether measured cytokines (IL-2, IL-6, IL-10, TNF-α, and TGF-α) change from the time of study entry to study completion.

To assess whether cytokine levels (IL-2, IL-6, IL-10, TNF-α, and TGF-α) correlate with circadian patterns in wrist actigraphy and self-described reports of fatigue as measured by the FACT-Fatigue at baseline and study completion.

Full Information

NCT ID

NCT01044004

First Posted

January 6, 2010

Last Updated

July 22, 2013

Sponsor

Washington University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT01044004

Brief Title

Evaluate the Efficacy of Armodafinil for Patients With B-cell Lymphoma and Severe Fatigue

Official Title

A Randomized, Double-Blind, Placebo-Controlled Pilot Study to Evaluate the Efficacy of Armodafinil for Patients With B-cell Lymphoma and Severe Fatigue Undergoing Standard R-CHOP Chemotherapy or in Remission Following Chemo and/or Radiation

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Withdrawn

Study Start Date

March 2010 (undefined)

Primary Completion Date

June 2012 (Anticipated)

Study Completion Date

June 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To determine whether armodafinil is more effective than placebo in reducing fatigue.

Detailed Description

Aims will be analyzed separately as stratified by treatment arm (chemotherapy treatment arm vs. post-treatment remission arm). Primary Objective: To determine whether armodafinil is more effective than placebo in reducing fatigue as measured by the change in scores from the FACT-Fatigue reported at study entry, week 7 of study treatment, and study completion (week 13). Secondary Objectives: To determine whether armodafinil is more effective than placebo in reducing fatigue as measured by standard actigraphy summary statistics including total sleep time (TST), wake after sleep onset (WASO), sleep latency, number of awakenings, daytime sleep time, mean daytime activity, peak activity, acrophase, and circadian mesor at week 1 of screening, week 7 of study treatment, and study completion (week 13). To determine whether armodafinil is more effective than placebo in improving work quality as measured by the change in scores from the WLQ© reported at study entry (week 1) and study completion (week 13). To determine whether armodafinil is more effective than placebo in reducing fatigue as measured by the change in activity patterns with actigraphy using applied functional data analysis during week 1 of screening, week 7 of study treatment, and study completion (week 13). To evaluate whether measured cytokines (IL-2, IL-6, IL-10, TNF-α, and TGF-α) are elevated at baseline. To evaluate whether measured cytokines (IL-2, IL-6, IL-10, TNF-α, and TGF-α) change from the time of study entry to study completion. To assess whether cytokine levels (IL-2, IL-6, IL-10, TNF-α, and TGF-α) correlate with circadian patterns in wrist actigraphy and self-described reports of fatigue as measured by the FACT-Fatigue at baseline and study completion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

B-cell Lymphoma, Fatigue

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Post treatment remission armodafinil

Arm Type

Experimental

Arm Description

Armodafinil 150 mg/day for 13 weeks

Arm Title

Post treatment remission placebo

Arm Type

Placebo Comparator

Arm Description

Placebo 150mg/day for 13 weeks

Arm Title

Chemotherapy armodafinil

Arm Type

Experimental

Arm Description

Armodafinil 150 mg/day for 13 weeks

Arm Title

Chemotherapy placebo

Arm Type

Placebo Comparator

Arm Description

Placebo 150mg/day for 13 weeks

Intervention Type

Drug

Intervention Name(s)

Armodafinil

Other Intervention Name(s)

Nuvigil

Intervention Description

Armodafinil 150 mg/day for 13 weeks

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Placebo 150mg/day for 13 weeks

Intervention Type

Drug

Intervention Name(s)

Armodafinil

Other Intervention Name(s)

Nuvigil

Intervention Description

Armodafinil 150 mg/day for 13 weeks

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Placebo 150mg/day for 13 weeks

Primary Outcome Measure Information:

Title

Time Frame

13 weeks

Secondary Outcome Measure Information:

Title

Time Frame

13 weeks

Title

Time Frame

13 weeks

Title

Time Frame

13 weeks

Title

To evaluate whether measured cytokines (IL-2, IL-6, IL-10, TNF-α, and TGF-α) are elevated at baseline.

Time Frame

13 weeks

Title

To evaluate whether measured cytokines (IL-2, IL-6, IL-10, TNF-α, and TGF-α) change from the time of study entry to study completion.

Time Frame

13 weeks

Title

Time Frame

13 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria for both arms: Age ≥ 18 with diagnosis of B-cell lymphoma Average score of ≥ 7 on daily worst fatigue severity assessment from the BFI questionnaire during screening Able to demonstrate appropriate use of the wrist actigraphy device and to complete questionnaires ECOG performance status 0-2 Laboratory values: Hemoglobin ≥ 10 g/dL Total Bilirubin ≤ 1.5 x institutional ULN AST/ALT ≤ 2.5 x institutional ULN Creatinine ≤ 1.5 x institutional ULN Albumin ≥ 3.5 g/dl Life expectancy > 6 months IRB-approved informed consent form must be signed before any protocol-specific screening procedures are performed. Inclusion criteria for patients undergoing R-CHOP chemotherapy: Scheduled to receive 6 cycles of standard R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) chemotherapy as first-line treatment Inclusion criteria for patients in remission following chemotherapy and/or radiotherapy: May have received one prior regimen of chemotherapy and/or radiotherapy Adequate response to upfront chemotherapy and/or radiotherapy Indolent lymphomas - must have achieved a partial or complete response with no immediate plans for further treatment Aggressive lymphomas - must have achieved a complete response: ≥ 4 weeks since completion of chemotherapy ≥ 8 weeks since completion of radiotherapy ≤ 18 months since completion of chemotherapy or radiotherapy Exclusion Criteria for both arms: Uncontrolled medical and/or psychiatric condition that may cause fatigue or that the PI feels is clinically significant and might adversely affect patient safety (such as sleep disorders, moderate/severe depression, metabolic/endocrine abnormalities, infections) History of clinically significant cardiac disorders, such as left ventricular hypertrophy or mitral valve prolapse experienced in conjunction with receiving CNS stimulants History of serious skin reactions, such as serious rash or Stevens-Johnson Syndrome Concurrent stimulant medication Any other active malignancy within the past 3 years except cervical carcinoma in situ and non-melanoma skin cancers Known CNS involvement by lymphoma Cachexia Use of opioids at time of randomization Known sensitivity to modafinil and/or armodafinil

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nina Wagner-Johnston, M

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

12. IPD Sharing Statement

Links:

URL

http://www.siteman.wustl.edu

Description

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

Evaluate the Efficacy of Armodafinil for Patients With B-cell Lymphoma and Severe Fatigue

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