The Efficacy and Tolerability of Modafinil for Fatigue and Daytime Sleepiness in Cancer Patients: Preliminary Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2016-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Open-pilot study for the efficacy and tolerability of modafinil on the fatigue and somnolence in cancer-patients.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Modafinil in Treating Fatigue in Patients With Cancer

NCT00112515

Cognitive/Functional Effects Depression Fatigue +1 more

UNKNOWN NA

Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer

NCT00052286

Brain and Central Nervous System Tumors Cognitive/Functional Effects Fatigue

COMPLETED NA

Modafinil to Improve Fatiguability

NCT05333250

RECRUITING PHASE1/PHASE2

Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer

NCT00042848

Fatigue Unspecified Adult Solid Tumor, Protocol Specific

COMPLETED PHASE3

Modafinil for the Treatment of Fatigue in Lung Cancer V9.0

NCT00829322

Carcinoma, Non-Small-Cell Lung

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is an open-pilot study for the efficacy and tolerability of modafinil on the fatigue and somnolence in cancer-patients. Patients with moderate to severe cancer-related fatigue will be treated with modafinil for 4 weeks and psychological tests including self-questionnaire, cognitive test, sleep-wake cycle, quantitative electroencephalogram(QEEG) will be applied pre- and post-treatment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fatigue

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group

Subjects who take modafinil for cancer-related fatigue for 4 weeks.

Group Type EXPERIMENTAL

Modafinil

Intervention Type DRUG

200mg of modafinil daily for 4 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Modafinil

200mg of modafinil daily for 4 weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Provigil

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* solid cancer patient
* age of 20-65 years old
* subjects who scored =4 or \>4 on the Brief Fatigue Inventory
* subjects with informed consent

Exclusion Criteria

* metastatic cancer(stage IV)
* with psychotic symptoms such as delusion and hallucination or with suicidal risk
* with delirium or dementia
* current medication of cognitive enhancer or psychostimulant uncontrolled medical illness
* current medications that are contraindicated or not recommended for co-administration with modafinil

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No