Palliative Morphine With or Without Concurrent Modafinil

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01766323
• Other study ID #: ModMorphine
• Status: Recruiting
• Phase: Phase 3
• First received: January 8, 2013
• Last updated: January 10, 2013
• Start date: September 2012
• Est. completion date: August 2013

Study information

• Verified date: January 2013
• Source: Dr. Rajendra Prasad Government Medical College
• Contact: Swaroop Revannasiddaiah, MD
• Phone: 918971862565
• Email: swarooptheone[@]gmail.com
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer
• Excessive Sleepiness
• Pain Palliation

Intervention

Drug:
• Modafinil
Oral modafinil at a dose of 100mg b.i.d along with the dose of oral morphine required for pain palliation
• Placebo
Oral placebo b.i.d, along with the dose of oral morphine required for pain palliation

Locations

Country	Name	City	State
India	Tanda Government Medical College and Hospital	Kangra	Himachal Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Rajendra Prasad Government Medical College

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No