Prospective Randomized Study Evaluating the Effects of Modafinil in Patients Receiving Oral Morphine for Pain Palliation
Overview
- Phase
- Phase 3
- Intervention
- Placebo
- Conditions
- Cancer
- Sponsor
- Dr. Rajendra Prasad Government Medical College
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Patient reported sleepiness scores
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Investigators
Swaroop Revannasiddaiah
Principal Investigator
Dr. Rajendra Prasad Government Medical College
Eligibility Criteria
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
Arms & Interventions
Arm Placebo
Oral placebo b.i.d, along with the dose of oral morphine required for pain palliation
Intervention: Placebo
Arm-Modafinil
Oral modafinil at a dose of 100mg b.i.d along with the dose of oral morphine required for pain palliation
Intervention: Modafinil
Outcomes
Primary Outcomes
Patient reported sleepiness scores
Time Frame: Three months from enrollment
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.
Secondary Outcomes
- Mood changes(Three months from enrollment)