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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm Placebo | Placebo Comparator | Oral placebo b.i.d, along with the dose of oral morphine required for pain palliation |
|
| Arm-Modafinil | Active Comparator | Oral modafinil at a dose of 100mg b.i.d along with the dose of oral morphine required for pain palliation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modafinil | Drug | Oral modafinil at a dose of 100mg b.i.d along with the dose of oral morphine required for pain palliation |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Swaroop Revannasiddaiah, MD | Contact | 918971862565 | swarooptheone@gmail.com | |
| Muninder K Negi, MD | Contact | 919805192039 | lippa@rediffmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Swaroop Revannasiddaiah, MD | Dr. Rajendra Prasad Government Medical College; Bangalore Institute of Oncology | Principal Investigator |
| Muninder K Negi, MD | Dr. Rajendra Prasad Government Medical College; Indira Gandhi Medical College |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanda Government Medical College and Hospital | Recruiting | Kangra | Himachal Pradesh | 176001 | India |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D006970 | Disorders of Excessive Somnolence |
| D000077260 | Sleepiness |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077408 | Modafinil |
| ID | Term |
|---|---|
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Placebo | Drug | Oral placebo b.i.d, along with the dose of oral morphine required for pain palliation |
|
| 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 Chair |
| D001523 |
| Mental Disorders |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |