Clinical trial · Interventional
Modafinil to Improve Fatiguability
Modafinil to Improve Fatiguability (MODIFY): Modafinil vs. Placebo Vanguard RCT
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer-related Cognitive Difficulties | — | UNRESOLVED | — |
| Cancer-related Problem/Condition | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Modafinil | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Modafinil
- description
- Two 100mg modafinil capsules once daily for 2 weeks
- interventionNames
- Drug: Modafinil
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Two 100mg placebo capsules once daily for 2 weeks
- interventionNames
- Other: Placebo
Primary outcomes (5)
- measure
- Fatigue
- timeFrame
- 2 weeks
- description
- Change in fatigue score evaluated using Multidimensional Fatigue Inventory (MFI).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18 years of age or older with stage III or IV cancer diagnosis 2. Estimated prognosis ≥ 3 months 3. Eastern Cooperative Oncology Group (ECOG) Score 0-2 4. 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) 5. Ability to understand and communicate in English 6. Ability to give first-person informed consent Exclusion Criteria: * 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) * Coronary artery disease with Canadian Cardiovascular Society Symptoms Class \>1 * Taking high dose selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants * Taking any benzodiazepine at any dose * Taking any amphetamine at any dose * Taking any monoamine oxidase inhibitor (MAOI) at any dose * Taking any azole anti-fungal medication (e.g., fluconazole, itraconazole, or ketoconazole) * Taking any of the following medications at any dose: 1. Methylphenidate 2. Cyclosporine 3. Propranolol 4. Phenytoin 5. S-mephenytoin 6. Warfarin 7. Triazolam 8. Ethinyl estradiol 9. Clomipramine 10. Midodrine 11. Antipyrine * Inability to ingest oral capsule * Pregnancy or lactation, or trying to conceive * Any other history, condition, therapy, or uncontrolled intercurrent illness which could, in the opinion of the Qualified Medical Investigator, affect compliance with study requirements or which would make the participant unsuitable for this study. * Simultaneous participation in another interventional clinical study (e.g., Phase 1-3 clinical studies) or treatment with any investigational medicinal product within 30 days prior to screening visit that could, in the judgment of the Qualified Medical Investigator, affect the patient's participation in or outcome of this clinical trial.
References
Publications (5)
- BACKGROUNDBerger 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 26285247
- BACKGROUNDJansen CE, Cancer Basics J, Eggert I (eds) (2010) Pittsburgh, PA:oncology nursing. Society
- BACKGROUNDWefel 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 25483452
- BACKGROUNDMurillo-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 29115823
- BACKGROUNDHovey 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 24337761