Chronic PainPhase 2/3NCT04589494
Effect of Tramadol Versus Morphine on PD1 and PD1-ligand in Patients With Chronic Cancer Pain
A Phase 2/3 study testing Tramadol Hydrochloride in people with Chronic Pain, run by Assiut University at 1 site in Egypt.
Trial summary
this work is looking for comparison between the effect of tramadol versus morphine on PD1 and PD1-ligand in patients with chronic cancer pain Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Tramadol Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Apr 2020to May 2021
- Phase
- Phase 2/3
- 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
- patients with cancer pain of varying etiology,
- documented metastatic cancer, currently on step I WHO ladder and whose pain necessitates a shift to step II,
- those who have never received radiotherapy, chemotherapy, or immunosuppressive drugs, -- and in good general and nutritional condition and without infectious diseases at the time of investigation.
Who cannot join
- abnormal hepatic, renal, and pulmonary function, gastrointestinal pathology, and
- those with cerebral metastases and/or psychological disorders,
- patients with contraindication to morphine or tramadol according to their respective data sheets, and
- patients who could not complete the diary information correctly.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut, 171516
Sahar A. Mohamed, MD, 01003611410, drsaher2008@yahoo.com
Shereen M. Mohamed, MD, 01006279209, sheridouh79@yahoo.com
About this study
Official title: Comparison Between the Effect of Tramadol Versus Morphine on PD1 and PD1-ligand in Patients With Chronic Cancer Pain
this work is looking for comparison between the effect of tramadol versus morphine on PD1 and PD1-ligand in patients with chronic cancer pain
Read the detailed description
The use of opioids is the mainstay in the treatment of many types of chronic pain, including cancer and non-cancer-related pain]. Opioids are known to suppress immune function following both acute and chronic administration; however, they appear to be different according to the schedule of administration as well as the state of the organism. Programmed death-1 (PD-1, also known as CD279) belongs to the CD28 receptor superfamily. It is an inhibitory receptor, and its expression is upregulated on activated leukocytes, resulting in an inhibited immune response. PD-1 interacts with two ligands: programmed death ligand-1 (PD-L1, also referred to as B7-H1) and programmed death ligand-2 (PD-L2, also known as B7-DC). PD-L2 is expressed mainly on activated dendritic cells (DCs) and macrophages, whereas PD-L1 is distributed widely. In addition to immune cells, some subsets of tumor cells also express PD-L1 to escape from immunosurveillance. It has been reported that the PD-1/PD-L1 pathway could be activated by surgical stress.
- Conditions
- Chronic Pain
- Being tested
- Tramadol Hydrochloride
- Keywords
- morphine, tramadol, PD1 and PD1 ligand
- Medical subject headings
- Chronic Pain, Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol HydrochlorideDrug
Also called morphine sulphate
tramadol hydrochloride 100 mg three times daily , morphine sulphate 30 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| tramadol group | Active comparator | tramadol hydrochloride 100 mg three times daily Receives: Drug: Tramadol Hydrochloride |
| morphine group | Active comparator | morphine 30 mg twise times daily Receives: Drug: Tramadol Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in PD1 and PD1ligand
this is flow cytomertic analyses to the human peripheral blood mononuclear cells (PBMCs) will be separated with a Ficoll-Isopaque density gradient. Flow cytometric analyses will be carried out immediately.
Measured: baseline(0), day15 , day 30
Secondary outcomes (1)
pain assessment
patient describ his pain severty from 0= no pain to 10= the most sever pain
Measured: baseline(0), day15 ,day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start16 Apr 2020
- Primary completionFeb 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shereen Mamdouh, Assiut University
- Investigators
- Shereen M Kamal, Associate Professor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589494
- Sponsor's protocol ID
- 493
- Status last verified
- Jan 2021
- First submitted
- 14 Sep 2020
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Effect of Tramadol Versus Morphine on PD1 and PD1-ligand in Patients With Chronic Cancer Pain
- ClinicalTrials.gov ID
- NCT04589494
- Acronym / sponsor ID
- 493
- Conditions
- Chronic Pain
- Keywords
- morphine, tramadol, PD1 and PD1 ligand
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 19 Oct 2020 (actual)
- 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.
this work is looking for comparison between the effect of tramadol versus morphine on PD1 and PD1-ligand in patients with chronic cancer pain
Detailed description
The use of opioids is the mainstay in the treatment of many types of chronic pain, including cancer and non-cancer-related pain]. Opioids are known to suppress immune function following both acute and chronic administration; however, they appear to be different according to the schedule of administration as well as the state of the organism. Programmed death-1 (PD-1, also known as CD279) belongs to the CD28 receptor superfamily. It is an inhibitory receptor, and its expression is upregulated on activated leukocytes, resulting in an inhibited immune response. PD-1 interacts with two ligands: programmed death ligand-1 (PD-L1, also referred to as B7-H1) and programmed death ligand-2 (PD-L2, also known as B7-DC). PD-L2 is expressed mainly on activated dendritic cells (DCs) and macrophages, whereas PD-L1 is distributed widely. In addition to immune cells, some subsets of tumor cells also express PD-L1 to escape from immunosurveillance. It has been reported that the PD-1/PD-L1 pathway could be activated by surgical stress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tramadol group | Active comparator | Drug: Tramadol Hydrochloridetramadol hydrochloride 100 mg three times daily |
| morphine group | Active comparator | Drug: Tramadol Hydrochloridemorphine 30 mg twise times daily |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with cancer pain of varying etiology,
- documented metastatic cancer, currently on step I WHO ladder and whose pain necessitates a shift to step II,
- those who have never received radiotherapy, chemotherapy, or immunosuppressive drugs, -- and in good general and nutritional condition and without infectious diseases at the time of investigation.
Key exclusion criteria (4 listed)
- abnormal hepatic, renal, and pulmonary function, gastrointestinal pathology, and
- those with cerebral metastases and/or psychological disorders,
- patients with contraindication to morphine or tramadol according to their respective data sheets, and
- patients who could not complete the diary information correctly.
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 |
|---|---|---|
| Tramadol HydrochlorideAlso: morphine sulphatetramadol hydrochloride 100 mg three times daily , morphine sulphate 30 mg twice daily | Drug | morphine group, tramadol group |
Primary outcome
changes in PD1 and PD1ligand
Time frame: baseline(0), day15 , day 30
this is flow cytomertic analyses to the human peripheral blood mononuclear cells (PBMCs) will be separated with a Ficoll-Isopaque density gradient. Flow cytometric analyses will be carried out immediately.
1 secondary outcome
pain assessment
Time frame: baseline(0), day15 ,day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
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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.
Shereen M Kamal, Associate Professor principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tramadol Hydrochloride in people with Chronic Pain, run by Assiut University at 1 site in Egypt.
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 3 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 14 Jan 2021. 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 Egypt. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 shereen M Kamal, Associate professor (01006279209, sheridouh79@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in PD1 and PD1ligand (time frame: baseline(0), day15 , day 30). 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 14 Jan 2021.