Palliative Morphine With or Without Concurrent Modafinil

Phase 3

• Conditions: Cancer; Pain Palliation; Excessive Sleepiness
• Interventions: Drug: Placebo; Drug: Modafinil

• Registration Number: NCT01766323
• Lead Sponsor: Dr. Rajendra Prasad Government Medical College

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Status Verified: 2013-01
• Study First Submitted: 2013-01-08
• Study First Submitted QC: 2013-01-10
• Last Update Submitted: 2013-01-10
• Study First Posted: 2013-01-11
• Last Update Posted: 2013-01-11
• Primary Completion: 2013-06
• Study Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm Placebo	Placebo	Oral placebo b.i.d, along with the dose of oral morphine required for pain palliation
Arm-Modafinil	Modafinil	Oral modafinil at a dose of 100mg b.i.d along with the dose of oral morphine required for pain palliation

Primary Outcome Measures

Name	Time	Method
Patient reported sleepiness scores	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 Outcome Measures

Name	Time	Method
Mood changes	Three months from enrollment	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).

Trial Locations

Locations (1)

Tanda Government Medical College and Hospital; 🇮🇳 Kangra, Himachal Pradesh, India