Health TrialsbyHealthPanel

Modafinil to Improve Fatiguability

ConditionsCancer-related Cognitive DifficultiesCancer-related Problem/ConditionFatigue
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Modafinil

    Drug

    Modafinil

  • Placebo

    Other intervention

    Placebo

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: ModafinilExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Fatigue

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

Time frame
2 weeks
2

Fatigue

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

Time frame
2 weeks
3

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%.

Time frame
2 years
4

Completion of intervention

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

Time frame
2 years

Secondary outcomes

1

Cognition

Change in cognition score evaluated using the Fast Cognitive Evaluation (FaCE).

Time frame
2 weeks
2

Quality of Life

Change in quality of life score evaluated using McGill Quality of Life Questionnaire-Revised (MQOL-R).

Time frame
2 weeks
3

Adverse events

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).

Time frame
2 weeks
4

Patient satisfaction with MFI

Patient satisfaction with MFI as a measure of their fatigue on a 5-point Likert scale.

Time frame
2 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ottawa Hospital Research Institute

Lead sponsor

The Ottawa Hospital

Collaborator

Source ClinicalTrials.gov
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