Palliative Morphine With or Without Concurrent Modafinil

NCT01766323 | Unknown Phase 3 DMC

• 1 other identifier: ModMorphine
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Pain Palliation; Excessive Sleepiness

Keywords

Morphine; Palliation; Cancer; Hospice; Sleepiness; Modafinil

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Mood changes

  Three months from enrollment

Study Arms (2)

Arm Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

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

Drug: Modafinil

Interventions

Modafinil DRUG

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

Arm-Modafinil

Placebo DRUG

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

Arm Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Rajendra Prasad Government Medical College: lead

Study Sites (1)

Tanda Government Medical College and Hospital

Kangra, Himachal Pradesh, 176001, India

RECRUITING

MeSH Terms

Conditions

Neoplasms; Disorders of Excessive Somnolence; Sleepiness

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• 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

  STUDY DIRECTOR

• 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

Central Study Contacts

Swaroop Revannasiddaiah, MD

CONTACT

918971862565; swarooptheone@gmail.com

Muninder K Negi, MD

CONTACT

919805192039; lippa@rediffmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 8, 2013
• First Posted: January 11, 2013
• Study Start: September 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: August 1, 2013
• Last Updated: January 11, 2013

Record last verified: 2013-01

Locations

IN (1)