Breast Cancer FemalePhase 4NCT03051503
Efficacy of Transdermal Fentanyl Patches in Relief of Acute Postoperative Pain After Mastectomy
A Phase 4 study testing The Transdermal Therapeutic System-Fentanyl (TTS-F) in people with Breast Cancer Female, run by South Egypt Cancer Institute at 1 site in Egypt.
Trial summary
to determine the safety, efficacy and tolerability of transdermal fentanyl in patients undergoing mastectomy, as well as the postoperative consumption of analgesic. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- The Transdermal Therapeutic System-Fentanyl (TTS-F)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Feb 2017to Apr 2017
- Phase
- Phase 4
- 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 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA I - II patients
- aged 30-60 years
- body weight ranged between 65-10kg
Who cannot join
- Patients with history of allergy to morphine
- chronic intake of analgesics or non-steroidal anti-inflammatory drug 24 h prior to surgery,
- there was a history of a psychiatric disorder patients weight was less then 50kg.
- impaired kidney function.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
South Egypt Cancer Institute, Assiut University, Assiut, Egypt.
Asyut, 171516
About this study
to determine the safety, efficacy and tolerability of transdermal fentanyl in patients undergoing mastectomy, as well as the postoperative consumption of analgesic.
- Conditions
- Breast Cancer Female
- Being tested
- The Transdermal Therapeutic System-Fentanyl (TTS-F), Intravenous patient-controlled analgesia (PCA) morphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Transdermal Therapeutic System-Fentanyl (TTS-F)Drug
Also called Fentanyl patch
(TTS-F) group (n=30) 50ug/h patch, placed 12 hours preoperatively
Intravenous patient-controlled analgesia (PCA) morphineDevice
Also called IV PCA morphine
IV PCA morphine for pain in the postoperative period.
| Study group | Role | What they receive |
|---|---|---|
| The Transdermal Therapeutic System-Fentanyl (TTS-F) group | Active comparator | (TTS-F) group (n=30) 50ug/h patch, placed 12 hs preoperatively. Receives: Drug: The Transdermal Therapeutic System-Fentanyl (TTS-F) |
| Intravenous patient-controlled analgesia (PCA) morphine | Placebo comparator | IV (PCA) morphine for pain in the postoperative period. Receives: Device: Intravenous patient-controlled analgesia (PCA) morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total dose of morphine consumption in the first 48 hours postoperative
Total dose of I.V. PCA morphine consumption in the first 48 hours postoperative
Measured: 48 hours
Visual Analogue Scale
Pain measurement scale
Measured: 48 hours
Secondary outcomes (2)
Level of stress hormones
Cortisol levels
Measured: 48 hours
Side effects related to the opioids
Nausea and vomiting; Itching; Respiratory depression.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start2 Feb 2017
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Egypt Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.mohamad farouk mohamad, South Egypt Cancer Institute
- Investigators
- Ahmed H Othman, MD, Study director, Cancer Institute, Anesthesia, Intensive Care, and Pain Management, South Egypt Cancer Institute, Assiut University, Assiut, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03051503
- Sponsor's protocol ID
- 228
- Status last verified
- Feb 2017
- First submitted
- 3 Feb 2017
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Transdermal Fentanyl Patches in Relief of Acute Postoperative Pain After Mastectomy
- ClinicalTrials.gov ID
- NCT03051503
- Acronym / sponsor ID
- 228
- Conditions
- Breast Cancer Female
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- South Egypt Cancer InstituteUniversity, hospital or other
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 13 Feb 2017 (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.
to determine the safety, efficacy and tolerability of transdermal fentanyl in patients undergoing mastectomy, as well as the postoperative consumption of analgesic.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Transdermal Therapeutic System-Fentanyl (TTS-F) group | Active comparator | Drug: The Transdermal Therapeutic System-Fentanyl (TTS-F)(TTS-F) group (n=30) 50ug/h patch, placed 12 hs preoperatively. |
| Intravenous patient-controlled analgesia (PCA) morphine | Placebo comparator | Device: Intravenous patient-controlled analgesia (PCA) morphineIV (PCA) morphine for pain in the postoperative period. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA I - II patients
- aged 30-60 years
- body weight ranged between 65-10kg
Key exclusion criteria (4 listed)
- Patients with history of allergy to morphine
- chronic intake of analgesics or non-steroidal anti-inflammatory drug 24 h prior to surgery,
- there was a history of a psychiatric disorder patients weight was less then 50kg.
- impaired kidney function.
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 |
|---|---|---|
| The Transdermal Therapeutic System-Fentanyl (TTS-F)Also: Fentanyl patch(TTS-F) group (n=30) 50ug/h patch, placed 12 hours preoperatively | Drug | The Transdermal Therapeutic System-Fentanyl (TTS-F) group |
| Intravenous patient-controlled analgesia (PCA) morphineAlso: IV PCA morphineIV PCA morphine for pain in the postoperative period. | Device | Intravenous patient-controlled analgesia (PCA) morphine |
Primary outcome
Total dose of morphine consumption in the first 48 hours postoperative
Time frame: 48 hours
Total dose of I.V. PCA morphine consumption in the first 48 hours postoperative
Visual Analogue Scale
Time frame: 48 hours
Pain measurement scale
2 secondary outcomes
Level of stress hormones
Time frame: 48 hours
Side effects related to the opioids
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
- Individual participant dataSharing planned: Yes
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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.
Ahmed H Othman, MD study director
Cancer Institute, Anesthesia, Intensive Care, and Pain Management, South Egypt Cancer Institute, Assiut University, Assiut, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing The Transdermal Therapeutic System-Fentanyl (TTS-F) in people with Breast Cancer Female, run by South Egypt Cancer Institute 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 24 Feb 2017. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 mohamad F mohamad, MD (+201093942354, mfaroukma@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total dose of morphine consumption in the first 48 hours postoperative (time frame: 48 hours). The study lists 2 primary outcomes in all. 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 24 Feb 2017.