Wounds and InjuriesPhase 2MorphineGELNCT05800834
Benefits of Morphine Gel for Pain Reduction in Patients With Cancer Wounds
A Phase 2 study testing Morphine Sulfate and Lidocaine Hcl 2% Jelly in people with Wounds and Injuries and Cancer Pain, run by Instituto Nacional de Cancer, Brazil at 1 site in Brazil.
Trial summary
The goal of this clinical trial is to compare in compare pain reduction in patients with malignant wounds using morphine gel or lidocaine gel. The main question to be answered is: Does morphine gel offer better pain control in malignant wounds when compared to lidocaine gel? Participants will answer a questionnaire… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds and Injuries, Cancer Pain, Cancer, Breast
- What is being tested?
- Morphine Sulfate and Lidocaine Hcl 2% Jelly
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteBrazil
- Study dates
- 12 Sep 2023to Apr 2024
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Malignant neoplastic wound in breast or head and neck;
- Malignant neoplastic wound with staging >= II;
- KPS >=30%
- Having at least 3 on the numerical pain rating scale (0-10);
- Admission time equal to or greater than 48 hours.
- Make use of systemic morphine.
Who cannot join
- Wound with fistula;
- Wound with extensive coagulation necrosis (>50% of wound area;
- Exuding wound > 1 (PUSH Scale);
- Bleeding wound >1 (VIBe Scale)
- Ongoing radiotherapy on the wound.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
National Cancer Institute
Rio de Janeiro, 20560121
Daianny A de Oliveira da Cunha, MSc., +55 (21) 98118-4111, daoliveira@inca.gov.br
About this study
Official title: Effectiveness of Topical Morphine Use in Patients With Painful Neoplastic Wounds in the Breast and Head and Neck: Double Blind Randomized Clinical Trial - MorphineGEL
The goal of this clinical trial is to compare in compare pain reduction in patients with malignant wounds using morphine gel or lidocaine gel. The main question to be answered is:
- Does morphine gel offer better pain control in malignant wounds when compared to lidocaine gel? Participants will answer a questionnaire where they report a note for pain at the site of the malignant wound and then the dressing will be performed by a nurse from the research team. The patient and the nurse do not know which product is being used. At the end of the dressing, the patient answers a new questionnaire. This process will be carried out for 3 days.
The researchers will compare the intervention group (morphine gel) and the control group (lidocaine gel) and verify if there is a difference in pain reduction between the two products.
Read the detailed description
Potential participants will be all patients with malignant wounds in the head and neck or breast region who meet the inclusion and exclusion criteria, forming the study population.
After signing the free and informed consent form, the intervention group will receive topical morphine based on hydrogel in the formulation of 10mg of morphine sulfate - intravenous solution (1 ml) with 8g of hydrogel and the control group will receive lidocaine in gel.
To ensure the quality and accuracy of the data, in addition to the safety of the research participants, face-to-face monitoring visits will be carried out by the team from the Representative Area of Clinical Research (ARPC)/INCA throughout the execution of this protocol.
After signing the TCLE by the patient and researcher, the completion of the clinical form will begin. The pharmacist of the research team responsible for the randomization will be contacted to inform the inclusion of the patient in the study. The research team doctor will be responsible for prescribing the medication to be used, be it morphine or lidocaine gel, with a view to release by the hospital pharmacy.
Both morphine gel and lidocaine gel will be prepared in a flow hood suitable for handling the medications.
Adverse events will be reported, using medical terminology, in the source document and in the eCRF (electronic case report form). Upon identification of a reaction, the participant will be evaluated by the research team physician. All measures required for the treatment of the adverse event will be recorded in the source document.
Randomization and allocation will be performed using Research Electronic Data Capture (REDCap) software in a form that will only be viewed by non-blind members of the pharmacy team, responsible for handling the products and sending them to the team nurse who will be responsible for wound dressing evil.
The data collection forms (eCRF) will be customized in the REDCap software by the representative research area (ARPC) data management team. The data will be entered into the eCRFs according to the standard operating procedures of the Division of Clinical Research-INCA. The data will be exported to the R software by API (Application Programming Interface) where the statistical analyzes will be performed.
The sample size of each group was determined using the G*Power application (version 3.1.9.4), using the Wilcoxon and Mann-Whitney nonparametric test approach. The calculation suggests a minimum sample size of 53 patients per group.
In the first part of the analysis, a descriptive analysis of the sample profile and comparison of the baseline variables of the control and intervention groups will be performed. The second part will evaluate the effect of the treatments in the control and intervention groups, analyzing the significance of the observed differences and the size of the treatment effect.
For qualitative variables, the significance of the association between two variables, or the difference between the distribution of the proportions of the two groups, will be investigated using the chi-square test and, when it proves to be inconclusive, Fisher's exact test will be used.
The odds ratio (OR) will be the measure used to express some risk of a qualitative outcome when comparing the occurrence of the outcome in the groups.
For quantitative variables, the normality of distributions will be verified by the Kolmogorov-Smirnov and Shapiro-Wilk tests. If the variable of interest has a normal distribution in both groups, the comparison will be made using the student's t-test; if at least one of the groups does not present normal distribution, or if the variable to be compared is an ordinal scale, such as the pain scale, the comparison of the two groups will be performed using the Mann-Whitney test.
Two repeated measures in different evaluations will be compared by the paired Student's t-test, if the two measures present normal distribution, or by the Wilcoxon signed rank test, if at least one of the measures does not present normal distribution or if it is a scale measure ordinal.
More than two repeated measures will be compared by ANOVA for repeated measures, in the case of normality for all measures, or by the Friedman test, if at least one of the measures does not present normal distribution, or if it is an ordinal scale measure.
Classifications or qualitative factors observed repeatedly at different times will be compared by McNemmar test.
The effect of the received intervention on the pain score will be evaluated by the Glass effect size measure.
- Conditions
- Wounds and Injuries, Cancer Pain, Cancer, Breast, Cancer Head Neck
- Being tested
- Morphine Sulfate, Lidocaine Hcl 2% Jelly
- Keywords
- Malignant fungating wounds, Painful wounds, Palliative care
- Medical subject headings
- Wounds and Injuries, Cancer Pain, Breast Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine SulfateDrug
Also called Dimorf
For the preparation of the gel formulated for the intervention, the proportion of an ampoule of dimorf® (morphine sulfate) in the injectable presentation of 10mg/ml will be used. Morphine sulfate is a strong, systemic opioid analgesic used for the relief of severe pain.
For the base of the compound, Curatec Hidrogel with Alginate® will be used. A transparent and viscous hydrogel, which provides a moist environment, preventing the dressing from adhering to the skin, preventing additional injuries generated by difficulty removing the dressing.
Lidocaine Hcl 2% JellyDrug
Also called Lidocaine gel
The control group will receive lidocaine® in gel (2% sterile jelly lidocaine hydrochloride) alone. Because it is a homogeneous, transparent gel, free of lumps and impurities, it has similar characteristics to the hydrogel (Curatec Hidrogel with Alginate®) used in the preparation of morphine gel, guaranteeing the blinding of the study.
| Study group | Role | What they receive |
|---|---|---|
| Morphine sulfate | Experimental | Topical morphine with hydrogel base. Receives: Drug: Morphine Sulfate |
| Lidocaine Hcl 2% jelly | Active comparator | 2% lidocaine jelly Receives: Drug: Lidocaine Hcl 2% Jelly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale
The scale assesses the intensity of pain, where 0 means no pain and 10 means the most intense pain possible
Measured: 3 days
Secondary outcomes (2)
Pain relief
Difference in the means of pain assessed by the numeric pain assessment scale before and after the intervention.
Measured: 3 days
General Comfort Questionnaire
General comfort questionnaire with scores ranging from 48-192, where 48 reports the worst comfort measure and 192 the highest comfort level reported by the patient.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start12 Sep 2023
- Primary completionMar 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancer, Brazil
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Daianny Arrais de Oliveira da Cunha, Instituto Nacional de Cancer, Brazil
- Investigators
- Daianny A de Oliveira da Cunha, MSc., Principal investigator, INCA Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800834
- Sponsor's protocol ID
- 56160922.7.3001.5274
- Acronym
- MorphineGEL
- Status last verified
- Sep 2023
- First submitted
- 20 Mar 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Topical Morphine Use in Patients With Painful Neoplastic Wounds in the Breast and Head and Neck: Double Blind Randomized Clinical Trial - MorphineGEL
- ClinicalTrials.gov ID
- NCT05800834
- Acronym / sponsor ID
- MorphineGEL / 56160922.7.3001.5274
- Conditions
- Wounds and Injuries, Cancer Pain, Cancer, Breast, Cancer Head Neck
- Keywords
- Malignant fungating wounds, Painful wounds, Palliative care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cancer, BrazilOther government
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 6 Apr 2023 (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.
The goal of this clinical trial is to compare in compare pain reduction in patients with malignant wounds using morphine gel or lidocaine gel. The main question to be answered is:
- Does morphine gel offer better pain control in malignant wounds when compared to lidocaine gel? Participants will answer a questionnaire where they report a note for pain at the site of the malignant wound and then the dressing will be performed by a nurse from the research team. The patient and the nurse do not know which product is being used. At the end of the dressing, the patient answers a new questionnaire. This process will be carried out for 3 days.
The researchers will compare the intervention group (morphine gel) and the control group (lidocaine gel) and verify if there is a difference in pain reduction between the two products.
Detailed description
Potential participants will be all patients with malignant wounds in the head and neck or breast region who meet the inclusion and exclusion criteria, forming the study population.
After signing the free and informed consent form, the intervention group will receive topical morphine based on hydrogel in the formulation of 10mg of morphine sulfate - intravenous solution (1 ml) with 8g of hydrogel and the control group will receive lidocaine in gel.
To ensure the quality and accuracy of the data, in addition to the safety of the research participants, face-to-face monitoring visits will be carried out by the team from the Representative Area of Clinical Research (ARPC)/INCA throughout the execution of this protocol.
After signing the TCLE by the patient and researcher, the completion of the clinical form will begin. The pharmacist of the research team responsible for the randomization will be contacted to inform the inclusion of the patient in the study. The research team doctor will be responsible for prescribing the medication to be used, be it morphine or lidocaine gel, with a view to release by the hospital pharmacy.
Both morphine gel and lidocaine gel will be prepared in a flow hood suitable for handling the medications.
Adverse events will be reported, using medical terminology, in the source document and in the eCRF (electronic case report form). Upon identification of a reaction, the participant will be evaluated by the research team physician. All measures required for the treatment of the adverse event will be recorded in the source document.
Randomization and allocation will be performed using Research Electronic Data Capture (REDCap) software in a form that will only be viewed by non-blind members of the pharmacy team, responsible for handling the products and sending them to the team nurse who will be responsible for wound dressing evil.
The data collection forms (eCRF) will be customized in the REDCap software by the representative research area (ARPC) data management team. The data will be entered into the eCRFs according to the standard operating procedures of the Division of Clinical Research-INCA. The data will be exported to the R software by API (Application Programming Interface) where the statistical analyzes will be performed.
The sample size of each group was determined using the G*Power application (version 3.1.9.4), using the Wilcoxon and Mann-Whitney nonparametric test approach. The calculation suggests a minimum sample size of 53 patients per group.
In the first part of the analysis, a descriptive analysis of the sample profile and comparison of the baseline variables of the control and intervention groups will be performed. The second part will evaluate the effect of the treatments in the control and intervention groups, analyzing the significance of the observed differences and the size of the treatment effect.
For qualitative variables, the significance of the association between two variables, or the difference between the distribution of the proportions of the two groups, will be investigated using the chi-square test and, when it proves to be inconclusive, Fisher's exact test will be used.
The odds ratio (OR) will be the measure used to express some risk of a qualitative outcome when comparing the occurrence of the outcome in the groups.
For quantitative variables, the normality of distributions will be verified by the Kolmogorov-Smirnov and Shapiro-Wilk tests. If the variable of interest has a normal distribution in both groups, the comparison will be made using the student's t-test; if at least one of the groups does not present normal distribution, or if the variable to be compared is an ordinal scale, such as the pain scale, the comparison of the two groups will be performed using the Mann-Whitney test.
Two repeated measures in different evaluations will be compared by the paired Student's t-test, if the two measures present normal distribution, or by the Wilcoxon signed rank test, if at least one of the measures does not present normal distribution or if it is a scale measure ordinal.
More than two repeated measures will be compared by ANOVA for repeated measures, in the case of normality for all measures, or by the Friedman test, if at least one of the measures does not present normal distribution, or if it is an ordinal scale measure.
Classifications or qualitative factors observed repeatedly at different times will be compared by McNemmar test.
The effect of the received intervention on the pain score will be evaluated by the Glass effect size measure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morphine sulfate | Experimental | Drug: Morphine SulfateTopical morphine with hydrogel base. |
| Lidocaine Hcl 2% jelly | Active comparator | Drug: Lidocaine Hcl 2% Jelly2% lidocaine jelly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Malignant neoplastic wound in breast or head and neck;
- Malignant neoplastic wound with staging >= II;
- KPS >=30%
- Having at least 3 on the numerical pain rating scale (0-10);
- Admission time equal to or greater than 48 hours.
Key exclusion criteria (5 listed)
- Wound with fistula;
- Wound with extensive coagulation necrosis (>50% of wound area;
- Exuding wound > 1 (PUSH Scale);
- Bleeding wound >1 (VIBe Scale)
- Ongoing radiotherapy on the wound.
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 |
|---|---|---|
| Morphine SulfateAlso: DimorfFor the preparation of the gel formulated for the intervention, the proportion of an ampoule of dimorf® (morphine sulfate) in the injectable presentation of 10mg/ml will be used. Morphine sulfate is a strong, systemic opioid analgesic used for the relief of severe pain. For the base of the compound, Curatec Hidrogel with Alginate® will be used. A transparent and viscous hydrogel, which provides a moist environment, preventing the dressing from adhering to the skin, preventing additional injuries generated by difficulty removing the dressing. | Drug | Morphine sulfate |
| Lidocaine Hcl 2% JellyAlso: Lidocaine gelThe control group will receive lidocaine® in gel (2% sterile jelly lidocaine hydrochloride) alone. Because it is a homogeneous, transparent gel, free of lumps and impurities, it has similar characteristics to the hydrogel (Curatec Hidrogel with Alginate®) used in the preparation of morphine gel, guaranteeing the blinding of the study. | Drug | Lidocaine Hcl 2% jelly |
Primary outcome
Numeric pain rating scale
Time frame: 3 days
The scale assesses the intensity of pain, where 0 means no pain and 10 means the most intense pain possible
2 secondary outcomes
Pain relief
Time frame: 3 days
General Comfort Questionnaire
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Daianny A de Oliveira da Cunha, MSc. principal investigator
INCA Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Morphine Sulfate and Lidocaine Hcl 2% Jelly in people with Wounds and Injuries and Cancer Pain, run by Instituto Nacional de Cancer, Brazil at 1 site in Brazil.
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 6 inclusion and 5 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 28 Sep 2023. 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 Brazil. 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 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.
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 Daianny A de Oliveira da Cunha, MSc. (+55 (21) 98118-4111, daoliveira@inca.gov.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric pain rating scale (time frame: 3 days). 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 28 Sep 2023.