Palliative Morphine With or Without Concurrent Modafinil

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

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.

Study Overview

• Status: Unknown
• Conditions: Cancer; Excessive Sleepiness; Pain Palliation
• Intervention / Treatment: Drug: Placebo; Drug: Modafinil

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Himachal Pradesh
    • Kangra, Himachal Pradesh, India, 176001
      • Recruiting
      • Tanda Government Medical College and Hospital
      • Contact: M N Kumar, MD; Phone Number: 9805192039

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Arm Placebo; Oral placebo b.i.d, along with the dose of oral morphine required for pain palliation	Drug: Placebo; Oral placebo b.i.d, along with the dose of oral morphine required for pain palliation
ACTIVE_COMPARATOR: Arm-Modafinil; Oral modafinil at a dose of 100mg b.i.d along with the dose of oral morphine required for pain palliation	Drug: Modafinil; Oral modafinil at a dose of 100mg b.i.d along with the dose of oral morphine required for pain palliation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dr. Rajendra Prasad Government Medical College
• Investigators: Principal Investigator: Swaroop Revannasiddaiah, MD, Dr. Rajendra Prasad Government Medical College; Bangalore Institute of Oncology; Study Director: Muninder K Negi, MD, Dr. Rajendra Prasad Government Medical College; Indira Gandhi Medical College; Study Chair: Sridhar P Susheela, MD, Bangalore Institute of Oncology; Study Chair: Madhup Rastogi, MD, Ram Manohar Lohia Insitute of Medical Sciences; Study Chair: Manoj K Gupta, MD, Indira Gandhi Medical College, Shimla

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ANTICIPATED): June 1, 2013
• Study Completion (ANTICIPATED): August 1, 2013

Study Registration Dates

• First Submitted: January 8, 2013
• First Submitted That Met QC Criteria: January 10, 2013
• First Posted (ESTIMATE): January 11, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): January 11, 2013
• Last Update Submitted That Met QC Criteria: January 10, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Cancer; Morphine; Sleepiness; Modafinil; Hospice; Palliation
• Additional Relevant MeSH Terms: Sleepiness; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Central Nervous System Stimulants; Wakefulness-Promoting Agents; Modafinil
• Other Study ID Numbers: ModMorphine