NCT05333250

Brief Summary

Cancer-related fatigue (CRF) and cancer-related cognitive impairment (CRCI) are among the most commonly reported disabling symptoms experienced by patients with advanced cancer. However, there are currently limited evidence-based pharmacologic interventions available. The investigators will conduct a Vanguard Randomized Clinical Trial (RCT) to estimate the effect of modafinil in managing CRF and CRCI, and to test the feasibility of carrying out the study.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
22mo left

Started Jan 2026

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress14%
Jan 2026Mar 2028

First Submitted

Initial submission to the registry

April 5, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 18, 2022

Completed
3.8 years until next milestone

Study Start

First participant enrolled

January 22, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

1.7 years

First QC Date

April 5, 2022

Last Update Submit

January 9, 2026

Conditions

Cancer-related Cognitive DifficultiesCancer-related Problem/ConditionFatigue

Keywords

CancerFatigueCognitive ImpairmentModafinil

Outcome Measures

Primary Outcomes (5)

  • Fatigue

    Change in fatigue score evaluated using Multidimensional Fatigue Inventory (MFI).

    2 weeks

  • Fatigue

    Change in fatigue score evaluated using Patient's Global Impression of Change (PGIC) score.

    2 weeks

  • Recruitment rate

    The number of patients approached, total participants screened for eligibility, and reason for ineligibility or refusal to participate will be documented. We will consider the study successful if we can enroll 40 participants over a 2-year study period, with a recruitment rate of 15%.

    2 years

  • Completion of intervention

    We will consider the intervention to be feasible if at least 75% of enrolled participants complete the full intervention protocol.

    2 years

  • Completion of follow-up

    We will consider the intervention to be feasible if at least 75% of enrolled participants complete all assessments at 1-week follow-up.

    2 years

Secondary Outcomes (4)

  • Cognition

    2 weeks

  • Quality of Life

    2 weeks

  • Adverse events

    2 weeks

  • Patient satisfaction with MFI

    2 weeks

Study Arms (2)

Modafinil

EXPERIMENTAL

Two 100mg modafinil capsules once daily for 2 weeks

Drug: Modafinil

Placebo

PLACEBO COMPARATOR

Two 100mg placebo capsules once daily for 2 weeks

Other: Placebo

Interventions

ModafinilDRUG

Modafinil

Also known as: Provigil
Modafinil
PlaceboOTHER

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

  • years of age or older with stage III or IV cancer diagnosis
  • Estimated prognosis ≥ 3 months
  • Eastern Cooperative Oncology Group (ECOG) Score 0-2
  • Experiencing cancer-related fatigue, defined as a score of 4 or greater on the Fatigue item of the Edmonton Symptom Assessment System-revised-constipation/sleep (ESAS-r-cs)
  • Ability to understand and communicate in English
  • Ability to give first-person informed consent

You may not qualify if:

  • Currently receiving or have received cytotoxic chemotherapy in the last 6 weeks
  • Allergy to modafinil or placebo contents
  • Dose change of prednisone or dexamethasone in the past 7 days or planned dose change during study period
  • Blood transfusion in the last 2 weeks
  • Hemoglobin lower than 80 g/L measured in the last 4 weeks
  • TSH above normal range in the last 4 weeks
  • Severe liver dysfunction (total bilirubin \>3x upper limit of normal, or aspartate aminotransferase or alanine aminotransferase \>5x upper limit of normal)
  • Known brain metastasis or primary brain tumor
  • Documented dementia diagnosis
  • Documented major psychiatric illness including major depressive episode, bipolar disorder, schizophrenia
  • Uncontrolled hypertension as defined by a blood pressure greater than 140/90mmHg
  • Unstable angina
  • Recent (\<6 months previous) myocardial infarction
  • Evidence of left ventricular hypertrophy or ischemia on ECG
  • Arrythmia (e.g., atrial fibrillation)
  • +22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, Canada

RECRUITING

Related Publications (5)

  • Berger AM, Mooney K, Alvarez-Perez A, Breitbart WS, Carpenter KM, Cella D, Cleeland C, Dotan E, Eisenberger MA, Escalante CP, Jacobsen PB, Jankowski C, LeBlanc T, Ligibel JA, Loggers ET, Mandrell B, Murphy BA, Palesh O, Pirl WF, Plaxe SC, Riba MB, Rugo HS, Salvador C, Wagner LI, Wagner-Johnston ND, Zachariah FJ, Bergman MA, Smith C; National comprehensive cancer network. Cancer-Related Fatigue, Version 2.2015. J Natl Compr Canc Netw. 2015 Aug;13(8):1012-39. doi: 10.6004/jnccn.2015.0122.

    PMID: 26285247BACKGROUND

  • Jansen CE, Cancer Basics J, Eggert I (eds) (2010) Pittsburgh, PA:oncology nursing. Society

    BACKGROUND

  • Wefel JS, Kesler SR, Noll KR, Schagen SB. Clinical characteristics, pathophysiology, and management of noncentral nervous system cancer-related cognitive impairment in adults. CA Cancer J Clin. 2015 Mar;65(2):123-38. doi: 10.3322/caac.21258. Epub 2014 Dec 5.

    PMID: 25483452BACKGROUND

  • Murillo-Rodriguez E, Barciela Veras A, Barbosa Rocha N, Budde H, Machado S. An Overview of the Clinical Uses, Pharmacology, and Safety of Modafinil. ACS Chem Neurosci. 2018 Feb 21;9(2):151-158. doi: 10.1021/acschemneuro.7b00374. Epub 2017 Dec 4.

    PMID: 29115823BACKGROUND

  • Hovey E, de Souza P, Marx G, Parente P, Rapke T, Hill A, Bonaventura A, Michele A, Craft P, Abdi E, Lloyd A; MOTIF investigators. Phase III, randomized, double-blind, placebo-controlled study of modafinil for fatigue in patients treated with docetaxel-based chemotherapy. Support Care Cancer. 2014 May;22(5):1233-42. doi: 10.1007/s00520-013-2076-0. Epub 2013 Dec 17.

    PMID: 24337761BACKGROUND

MeSH Terms

Conditions

FatigueNeoplasmsCognitive Dysfunction

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Benzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Edward Fitzgibbon, MD, MSc, CCFP(PC)

    The Ottawa Hospital

    PRINCIPAL INVESTIGATOR

  • James Downar, MDCM, MHSc

    The Ottawa Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shainuka Kannathas, HBSc

CONTACT

(613) 562-6262shkannathas@ohri.ca

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2022

First Posted

April 18, 2022

Study Start

January 22, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

January 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)