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


Phase 3
18 Years
70 Years
Open (Enrolling)
Both
Cancer, Pain Palliation, Excessive Sleepiness

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Patient reported sleepiness scores

Outcome Description:

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.

Outcome Time Frame:

Three months from enrollment

Safety Issue:

No

Principal Investigator

Swaroop Revannasiddaiah, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dr. Rajendra Prasad Government Medical College; Bangalore Institute of Oncology

Authority:

India: Institutional Review Board

Study ID:

ModMorphine

NCT ID:

NCT01766323

Start Date:

September 2012

Completion Date:

August 2013

Related Keywords:

  • Cancer
  • Pain Palliation
  • Excessive Sleepiness
  • Morphine
  • Palliation
  • Cancer
  • Hospice
  • Sleepiness
  • Modafinil

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