NCT00178373

Brief Summary

The purpose of this study is to determine the efficacy of modafinil with regard to reducing cancer-related fatigue in cancer patients following chemotherapy or radiation therapy. Secondarily, the effect of modafinil on cognitive dysfunction in the same population will be assessed. The researchers hypothesize that administering modafinil (PROVIGIL®) to patients experiencing fatigue following completion of cancer treatment will lead to reduction in patient fatigue and prevention of or improvement in patient cognitive dysfunction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_2 cancer

Timeline
Completed

Started May 2004

Shorter than P25 for phase_2 cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

December 23, 2015

Status Verified

December 1, 2015

Enrollment Period

1.6 years

First QC Date

September 12, 2005

Last Update Submit

December 21, 2015

Conditions

CancerFatigueChemotherapy

Keywords

cancer-related fatiguechemotherapymodafinil

Outcome Measures

Primary Outcomes (1)

  • degree to which modafinil can reduce patient fatigue following treatment for cancer

    4 weeks

Secondary Outcomes (4)

  • cytokine blood levels

  • depression measured by the Center for Epidemiologic Studies-Depression scale (CES-D)

  • cognitive function measured by the Cognitive Drug Research (CDR) Cognitive Assessment

  • psychological adjustment to cancer measured by the Mini-Mental Adjustment to Cancer scale (Mini-MAC)

Study Arms (2)

Modafinil

EXPERIMENTAL

Modafinil 200 mg taken by mouth once a day. Subjects will take 2 100 mg tablets each morning.

Drug: Modafinil

placebo

PLACEBO COMPARATOR

Inactive sugar pill, 2 are taken once a day in the morning

Drug: sugar pill

Interventions

ModafinilDRUG
Modafinil
sugar pillDRUG
placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is longer than one-month post chemotherapy and/or radiation treatment for an initial diagnosis of cancer
  • Patient is 18 years of age or older
  • Patient is able to swallow medication
  • Patient has a Brief Fatigue Inventory (BFI) question #3 "fatigue worst" score of 2 or greater

You may not qualify if:

  • Patient has ever taken modafinil (PROVIGIL)
  • Patient has taken an anticonvulsant for a seizure disorder; has taken any of the following on a regular basis within the past 30 days, a psychostimulant (e.g., amphetamines, methylphenidate \[Ritalin\], pemoline \[Cylert\]), or a monoamine oxidase inhibitor (MAOIs)
  • Patient has a history of clinically significant cardiac disease, uncontrolled hypertension, alcohol or drug abuse, severe headaches, glaucoma, seizure disorder, narcolepsy, a psychotic disorder, or Tourette's syndrome
  • Patient presently taking on a regular basis:
  • an anticoagulant (Coumadin \[warfarin\], heparin); note that low dose Coumadin (1 mg by mouth daily) given for maintenance of venous access devices is acceptable
  • alpha-interferon or interleukin-2,
  • a corticosteroid (dexamethasone, prednisone, prednisolone)
  • Patient has a narrowing (pathological or iatrogenic) or obstruction of the gastrointestinal tract
  • Patient is currently pregnant or nursing (if currently using a steroidal contraceptive for fertility control, participant must agree to use a barrier method of contraception during the study and for one full menstrual cycle following the study
  • Patient has uncontrolled anemia; receiving treatment for anemia and currently stable is acceptable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester, James P. Wilmot Cancer Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

NeoplasmsFatigue

Interventions

ModafinilSugars

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsCarbohydrates

Study Officials

  • Gary R. Morrow, Ph.D., M.S.

    University of Rochester, James P. Wilmot Cancer Center, Radiation Oncology Department, Behavioral Medicine Unit, Box 704, 601 Elmwood Avenue, Rochester, NY 14642

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

May 1, 2004

Primary Completion

December 1, 2005

Study Completion

March 1, 2006

Last Updated

December 23, 2015

Record last verified: 2015-12

Locations

US(1)