Cancer, Excessive Sleepiness, Pain Palliation
Conditions
Keywords
Morphine, Palliation, Cancer, Hospice, Sleepiness, Modafinil
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.
Interventions
DRUGModafinil
Oral modafinil at a dose of 100mg b.i.d along with the dose of oral morphine required for pain palliation
DRUGPlacebo
Oral placebo b.i.d, along with the dose of oral morphine required for pain palliation
Sponsors
Dr. Rajendra Prasad Government Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
India
Contacts
Primary ContactSwaroop Revannasiddaiah, MD
Backup ContactMuninder K Negi, MD
Outcome results
None listed