Palliative Morphine With or Without Concurrent Modafinil

Dr. Rajendra Prasad Government Medical College

Status and phase: Unknown; Phase 3

Conditions: Pain Palliation; Excessive Sleepiness; Cancer

Treatments: Drug: Modafinil; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01766323

ModMorphine

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

200 participants in 2 patient groups, including a placebo group

Arm Placebo

Placebo Comparator group

Description:

Oral placebo b.i.d, along with the dose of oral morphine required for pain palliation

Treatment:

Drug: Placebo

Arm-Modafinil

Active Comparator group

Description:

Oral modafinil at a dose of 100mg b.i.d along with the dose of oral morphine required for pain palliation

Treatment:

Drug: Modafinil