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Cancer | Palliative Morphine With or Without Concurrent Modafinil

Cancer research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Cancer

Pain Palliation

Excessive Sleepiness

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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

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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

Study Status

Unknown status

Start Date: September 2012

Completed Date: August 2013

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Patient reported sleepiness scores

Secondary Outcome: Mood changes

Study sponsors, principal investigator, and references

Principal Investigator: Swaroop Revannasiddaiah, MD

Lead Sponsor: Dr. Rajendra Prasad Government Medical College

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01766323

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