Palliative Morphine With or Without Concurrent Modafinil

• Status: Unknown status
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Rajendra Prasad Government Medical College
• Treatments: Armodafinil; Modafinil; Morphine

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