CancerPhase 3NCT01766323
Palliative Morphine With or Without Concurrent Modafinil
A Phase 3 study testing Modafinil in people with Cancer and Pain Palliation, run by Dr. Rajendra Prasad Government Medical College at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cancer, Pain Palliation, Excessive Sleepiness
- What is being tested?
- Modafinil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2012to Aug 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Tanda Government Medical College and Hospital
Kangra, Himachal Pradesh, 176001
M N Kumar, MD, 9805192039
Swaroop Revannasiddaiah, MD
About this study
Official title: Prospective Randomized Study Evaluating the Effects of Modafinil in Patients Receiving Oral Morphine for Pain Palliation
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
- Being tested
- Modafinil, Placebo
- Keywords
- Morphine, Palliation, Cancer, Hospice, Sleepiness, Modafinil
- Medical subject headings
- Neoplasms, Disorders of Excessive Somnolence, Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ModafinilDrug
Oral modafinil at a dose of 100mg b.i.d along with the dose of oral morphine required for pain palliation
PlaceboDrug
Oral placebo b.i.d, along with the dose of oral morphine required for pain palliation
| Study group | Role | What they receive |
|---|---|---|
| Arm Placebo | Placebo comparator | Oral placebo b.i.d, along with the dose of oral morphine required for pain palliation Receives: 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 Receives: Drug: Modafinil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three months from enrollment
Secondary outcomes (1)
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).
Measured: Three months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startSep 2012
- Primary completionJun 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Rajendra Prasad Government Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Swaroop Revannasiddaiah, Dr. Rajendra Prasad Government Medical College
- Investigators
- Swaroop Revannasiddaiah, MD, Principal investigator, Dr. Rajendra Prasad Government Medical College; Bangalore Institute of OncologyMuninder K Negi, MD, Study director, Dr. Rajendra Prasad Government Medical College; Indira Gandhi Medical CollegeSridhar P Susheela, MD, Study chair, Bangalore Institute of OncologyMadhup Rastogi, MD, Study chair, Ram Manohar Lohia Insitute of Medical SciencesManoj K Gupta, MD, Study chair, Indira Gandhi Medical College, Shimla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01766323
- Sponsor's protocol ID
- ModMorphine
- Status last verified
- Jan 2013
- First submitted
- 8 Jan 2013
- Last updated
- 11 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study Evaluating the Effects of Modafinil in Patients Receiving Oral Morphine for Pain Palliation
- ClinicalTrials.gov ID
- NCT01766323
- Acronym / sponsor ID
- ModMorphine
- Conditions
- Cancer, Pain Palliation, Excessive Sleepiness
- Keywords
- Morphine, Palliation, Cancer, Hospice, Sleepiness, Modafinil
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Dr. Rajendra Prasad Government Medical CollegeUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 11 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm Placebo | Placebo comparator | Drug: PlaceboOral placebo b.i.d, along with the dose of oral morphine required for pain palliation |
| Arm-Modafinil | Active comparator | Drug: ModafinilOral modafinil at a dose of 100mg b.i.d along with the dose of oral morphine required for pain palliation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosed and confirmed malignancy
- Able to orally consume tablets
- Blood Pressure: Systolic <144mmHg; Diastolic <92mmHg
- Normal blood sugar
- No active systemic infections
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ModafinilOral modafinil at a dose of 100mg b.i.d along with the dose of oral morphine required for pain palliation | Drug | Arm-Modafinil |
| PlaceboOral placebo b.i.d, along with the dose of oral morphine required for pain palliation | Drug | Arm Placebo |
Primary outcome
Patient reported sleepiness scores
Time frame: 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.
1 secondary outcome
Mood changes
Time frame: Three months from enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Swaroop Revannasiddaiah, MD principal investigator
Dr. Rajendra Prasad Government Medical College; Bangalore Institute of Oncology
Muninder K Negi, MD study director
Dr. Rajendra Prasad Government Medical College; Indira Gandhi Medical College
Sridhar P Susheela, MD study chair
Bangalore Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Modafinil in people with Cancer and Pain Palliation, run by Dr. Rajendra Prasad Government Medical College at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Swaroop Revannasiddaiah, MD (918971862565, swarooptheone@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reported sleepiness scores (time frame: Three months from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2013.