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Palliative Morphine With or Without Concurrent Modafinil

Primary Purpose

Cancer, Pain Palliation, Excessive Sleepiness

Status

Unknown status

Phase

Phase 3

Locations

India

Study Type

Interventional

Intervention

Modafinil

Placebo

About this trial

This is an interventional supportive care trial for Cancer focused on measuring Morphine, Palliation, Cancer, Hospice, Sleepiness, Modafinil

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Tanda Government Medical College and HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Arm Placebo

Arm-Modafinil

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

NCT ID

NCT01766323

First Posted

January 8, 2013

Last Updated

January 10, 2013

Sponsor

Dr. Rajendra Prasad Government Medical College

1. Study Identification

Unique Protocol Identification Number

NCT01766323

Brief Title

Palliative Morphine With or Without Concurrent Modafinil

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Unknown status

Study Start Date

September 2012 (undefined)

Primary Completion Date

June 2013 (Anticipated)

Study Completion Date

August 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dr. Rajendra Prasad Government Medical College

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer, Pain Palliation, Excessive Sleepiness

Keywords

Morphine, Palliation, Cancer, Hospice, Sleepiness, Modafinil

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Arm-Modafinil

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Modafinil

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Patient reported sleepiness scores

Description

Time Frame

Three months from enrollment

Secondary Outcome Measure Information:

Title

Mood changes

Description

Time Frame

Three months from enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Swaroop Revannasiddaiah, MD

Phone

918971862565

swarooptheone@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Muninder K Negi, MD

Phone

919805192039

lippa@rediffmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Swaroop Revannasiddaiah, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Muninder K Negi, MD

Organizational Affiliation

Dr. Rajendra Prasad Government Medical College; Indira Gandhi Medical College

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Sridhar P Susheela, MD

Organizational Affiliation

Bangalore Institute of Oncology

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Madhup Rastogi, MD

Organizational Affiliation

Ram Manohar Lohia Insitute of Medical Sciences

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Manoj K Gupta, MD

Organizational Affiliation

Indira Gandhi Medical College, Shimla

Official's Role

Study Chair

Facility Information:

Facility Name

Tanda Government Medical College and Hospital

City

Kangra

State/Province

Himachal Pradesh

ZIP/Postal Code

176001

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

M N Kumar, MD

Phone

9805192039

First Name & Middle Initial & Last Name & Degree

Swaroop Revannasiddaiah, MD

12. IPD Sharing Statement

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Palliative Morphine With or Without Concurrent Modafinil

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