Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2026-01-11 @ 7:31 PM
Study NCT ID:
NCT05333250
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-12
First Post:
2022-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modafinil to Improve Fatiguability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077408', 'term': 'Modafinil'}], 'ancestors': [{'id': 'D001559', 'term': 'Benzhydryl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-08', 'studyFirstSubmitDate': '2022-04-05', 'studyFirstSubmitQcDate': '2022-04-13', 'lastUpdatePostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fatigue', 'timeFrame': '2 weeks', 'description': 'Change in fatigue score evaluated using Multidimensional Fatigue Inventory (MFI).'}, {'measure': 'Fatigue', 'timeFrame': '2 weeks', 'description': "Change in fatigue score evaluated using Patient's Global Impression of Change (PGIC) score."}, {'measure': 'Recruitment rate', 'timeFrame': '2 years', 'description': '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%.'}, {'measure': 'Completion of intervention', 'timeFrame': '2 years', 'description': 'We will consider the intervention to be feasible if at least 75% of enrolled participants complete the full intervention protocol.'}, {'measure': 'Completion of follow-up', 'timeFrame': '2 years', 'description': 'We will consider the intervention to be feasible if at least 75% of enrolled participants complete all assessments at 1-week follow-up.'}], 'secondaryOutcomes': [{'measure': 'Cognition', 'timeFrame': '2 weeks', 'description': 'Change in cognition score evaluated using the Fast Cognitive Evaluation (FaCE).'}, {'measure': 'Quality of Life', 'timeFrame': '2 weeks', 'description': 'Change in quality of life score evaluated using McGill Quality of Life Questionnaire-Revised (MQOL-R).'}, {'measure': 'Adverse events', 'timeFrame': '2 weeks', 'description': 'Daily patient-reported adverse effects with specific focus on headache, nausea and vomiting and anxiety, evaluated using the Common Terminology Criteria for Adverse Events (CTCAE).'}, {'measure': 'Patient satisfaction with MFI', 'timeFrame': '2 weeks', 'description': 'Patient satisfaction with MFI as a measure of their fatigue on a 5-point Likert scale.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer', 'Fatigue', 'Cognitive Impairment', 'Modafinil'], 'conditions': ['Cancer-related Cognitive Difficulties', 'Cancer-related Problem/Condition', 'Fatigue']}, 'referencesModule': {'references': [{'pmid': '26285247', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'Jansen CE, Cancer Basics J, Eggert I (eds) (2010) Pittsburgh, PA:oncology nursing. Society'}, {'pmid': '25483452', 'type': 'BACKGROUND', 'citation': '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': '29115823', 'type': 'BACKGROUND', 'citation': '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': '24337761', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Background:\n\nPatients with advanced cancer often experience various disabling symptoms. Cancer-related fatigue (CRF) and cancer-related cognitive impairment (CRCI) are among the most common reported symptoms, yet the availability of evidence-based pharmacologic interventions is limited.\n\nCRF can be defined as a "distressing, persistent, subjective sense of physical, emotional, and/or cognitive tiredness or exhaustion related to cancer or cancer treatment that is not proportional to recent activity and interferes with usual functioning." CRF is experienced by over 75% of patients with advanced cancer.\n\nCRCI is defined as a decline in one or more areas of cognitive function, including attention and concentration, executive functioning, information processing speed, language, visuospatial skill, psychomotor ability, and memory. It is estimated that up to 40% of patients experience CRCI prior to any treatment; up to 75% during their treatment; and up to 60% upon completion of therapies.\n\nModafinil is a psychostimulant that has been studied in the context of CRF and daytime sleepiness. Its mechanism of action is not clear, but it is thought to promote wakefulness through dopaminergic neurotransmission which has been hypothesized to play a role in CRF.\n\nStudy Hypothesis:\n\nModafinil will improve CRF and CRCI\n\nStudy Objectives:\n\n1. To estimate the effect size of modafinil in managing CRF and CRCI\n2. To test the feasibility of carrying out the study (recruitment, etc.)\n\nStudy Design:\n\nRandomized, placebo-controlled, double-blind, single-centre vanguard trial\n\nSample Size \\& Study Population:\n\nApproximately 40 outpatients presenting ≥4/10 on the fatigue score of their screening questionnaire will be recruited. Eligible patients must be 18-75 years old with advanced cancer who have not received cytotoxic chemotherapy for at least one month.\n\nIntervention:\n\nSubjects will be randomized to receive 200 mg of modafinil or placebo once daily for one week.\n\nStudy Outcome Measures:\n\nUsing validated questionnaires and a digital tool, the investigators will assess the patient\'s fatigue (CRF), cognition (CRCI), and quality of life before and after the intervention. In addition, patients will report their global impression of change.\n\nFinally, if patients experience any adverse events (headache, nausea, vomiting, anxiety, etc.), they will report them using a standard questionnaire. Adverse events (AEs) and Serious Adverse Events (SAEs) will be documented.\n\nExpected Outcomes:\n\nPositive results should provide justification to prolong the study to complete a phase III trial. This study is important because fatigue remains a cause of suffering amongst palliative patients with cancer. Modafinil has the potential to improve patients\' fatigue, cognition, and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stage III or IV cancer diagnosis;\n* Has been off cytotoxic chemotherapy for at least 6 weeks;\n* Eastern Cooperative Oncology Group (ECOG) score of 0-2;\n* Experiencing CRF, defined as score of 4 or greater on the Fatigue item of the Edmonton Symptom Assessment System-revised (ESAS-r);\n* Prognosis of at least 3 months;\n* Able to understand and communicate in English and/or French;\n* Able to give first-person informed consent.\n\nExclusion Criteria:\n\n* Allergy to modafinil;\n* Dose change of prednisone or dexamethasone in the past 7 days or planned dose change during study period;\n* Received blood transfusion in the past 2 weeks;\n* Hemoglobin lower than 80 g/L measured within 2 weeks of enrolment;\n* Thyroid Stimulating Hormone (TSH) above normal range (measured within 2 weeks or start date);\n* Patients with known brain metastasis or primary brain tumors;\n* Documented dementia diagnosis;\n* Documented major psychiatric illness including major depressive episode, bipolar disorder, or schizophrenia;\n* Uncontrolled hypertension, defined as blood pressure higher than 140/80;\n* Inability to ingest oral capsule;\n* Pregnant or lactating;\n* Severe liver dysfunction, defined as newly developed liver enzyme elevation total bilirubin \\>3 upper limits of normal, aspartate aminotransferase or alanine aminotransferase \\>5 upper limits of normal.'}, 'identificationModule': {'nctId': 'NCT05333250', 'acronym': 'MODIFY', 'briefTitle': 'Modafinil to Improve Fatiguability', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Hospital Research Institute'}, 'officialTitle': 'Modafinil to Improve Fatiguability (MODIFY): Modafinil vs. Placebo Vanguard RCT', 'orgStudyIdInfo': {'id': '663439'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Modafinil', 'description': 'One 200mg modafinil capsule once daily for one week', 'interventionNames': ['Drug: Modafinil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'One placebo capsule once daily for one week', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Modafinil', 'type': 'DRUG', 'otherNames': ['Provigil'], 'description': 'Modafinil', 'armGroupLabels': ['Modafinil']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'James Downar, MDCM, MHSc', 'role': 'CONTACT', 'email': 'jdownar@toh.ca'}], 'facility': 'The Ottawa Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'centralContacts': [{'name': 'Shainuka Kannathas, HBSc', 'role': 'CONTACT', 'email': 'skannathas@bruyere.org', 'phone': '(613) 562-6262', 'phoneExt': '2354'}], 'overallOfficials': [{'name': 'Edward Fitzgibbon, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Ottawa Hospital'}, {'name': 'James Downar, MDCM, MHSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Ottawa Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Hospital Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Ottawa Hospital', 'class': 'OTHER'}, {'name': 'Bruyère Health Research Institute.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}