Palliative Morphine With or Without Concurrent Modafinil

Study Overview
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Brief Summary
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Oral morphine is often utilized as a convenient and effective method of achieving palliation of pain in the terminally ill cancer patients. However, at effective doses, a majority of patients do experience an undue amount of excessive sleepiness. Given the generally low expected survival periods among this patient population, the fact that morphine causes the patient to spend a significant period of remaining life in sleep, is often unacceptable for the patients and their families. Given the proven benefits of modafinil in conditions characterized by excessive sleepiness (such as with narcolepsy and shift-work disorder), the investigators designed a prospective placebo controlled randomized trial by the addition of modafinil at a dose of 200mg per day (in two divided doses) for eligible patients after randomization.

Official Title
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Prospective Randomized Study Evaluating the Effects of Modafinil in Patients Receiving Oral Morphine for Pain Palliation

Conditions
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Cancer, Pain Palliation, Excessive Sleepiness

Intervention / Treatment
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* Drug: Modafinil
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed and confirmed malignancy Able to orally consume tablets Blood Pressure: Systolic <144mmHg; Diastolic <92mmHg Normal blood sugar No active systemic infections Consenting Oral morphine being consumed as a part of terminal symptom palliation Exclusion Criteria: Candidates receiving oral morphine for temporary pain management, such as being potential candidates for radical curative approaches in the future Poor performance status (Karnofsky Performance Status score <50) Prior history of hypertension, diabetes, tuberculosis, epilepsy Prior history of psychiatric and neurological illness

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Arm Placebo<br>Oral placebo b.i.d, along with the dose of oral morphine required for pain palliation | Drug: Placebo<br>* Oral placebo b.i.d, along with the dose of oral morphine required for pain palliation<br>|
| Active Comparator: Arm-Modafinil<br>Oral modafinil at a dose of 100mg b.i.d along with the dose of oral morphine required for pain palliation | Drug: Modafinil<br>* Oral modafinil at a dose of 100mg b.i.d along with the dose of oral morphine required for pain palliation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported sleepiness scores | Patient reported sleepiness scores will be recorded as per a visual analogue scale with scores ranging from 1 (no unusual sleepiness) to 5 (unable to stay awake). Recordings will be done on the first day of intervention, and repeated recordings will be procured once every two weeks till a total of seven readings are obtained over a time span of 3 months. | Three months from enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood changes | Patients will be requested to report their self-perceived mood status by choosing one of three discrete options (improvement, worsening, no change). Each patient will provide a total of three responses over a period of three months from enrollment (at the end of each month from enrollment). | Three months from enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Morphine, Palliation, Cancer, Hospice, Sleepiness, Modafinil