Wounds and Injuries

All Conditions

Neoplasms

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Nervous System Diseases

Head and Neck Neoplasms

Cancer Pain

Pain

Breast Neoplasms

Neurologic Manifestations

Breast Diseases

Skin Diseases

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Lidocaine

Morphine

Analgesics, Opioid

Anesthetics

Anesthetics, Local

Sodium Channel Blockers

Diuretics, Potassium Sparing

Narcotics

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.

Morphine Sulfate

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.

Lidocaine Hcl 2% Jelly

Daianny A de Oliveira da Cunha, MSc.

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.

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.

Benefits of Morphine Gel for Pain Reduction in Patients With Cancer Wounds

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 scale assesses the intensity of pain, where 0 means no pain and 10 means the most intense pain possible

Difference in the means of pain assessed by the numeric pain assessment scale before and after the intervention.

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.

Instituto Nacional de Cancer, Brazil

Principal Investigator

Behaviors and Mental Disorders

Quality of Life

malignant fungating wounds care regimen based on the evidences, expert consultation, pre-experiment and final determination

1) Preliminary construction of regimen: The researchers summarized the literatures and guidelines about malignant fungating wounds care, and then formed a preliminary draft of the regimen.2) Expert consultation: Experts in malignant fungating wound care, breast cancer and rehabilitation were consulted by email, and the researchers revised the protocol according to the experts' comments, and the final draft was determined after multiple rounds of consultation with experts. 3) Pre-experiment: The researchers investigated the enrolled patients to assess the feasibility of the protocol, and adjusted the content based on the feedback.4) Final Determining: including health records establishment, the intervention time, implementers, location, method and frequency. A wound care team was formed, interventions were carried out in terms of somatic care, wound home care, psychological support, and rehabilitation guidance, and the enrolled patients would be regularly followed by the researchers.

malignant fungating wounds care regimen

liangzhi Qiu, M.D.

Liangzhi Qiu, M.D.

Patients with breast cancer malignant fungating wounds have six specific symptoms caused by wounds: malodor, pain, massive exudate, bleeding, infection, and pruritus. Malignant fungating wounds cause patients' physical condition and social function to be severely restricted, and the cost of wound dressing change further increases financial pressure, which leads to low self-identity, complex and variable emotions, and low quality of life. Therefore, the care of patients with malignant fungating wounds focuses on symptom management with the aim of improving the quality of life. There are scarce well-defined wound symptom management programs for this group, and most focus on wound management while ignoring the impact on the patient's body and mind. This study will construct malignant fungating wounds care regimen for breast cancer patients in order to improve the quality of life.

Patients with breast cancer malignant fungating wounds have six specific symptoms caused by wounds: malodor, pain, massive exudate, bleeding, infection, and pruritus, and there is an interrelationship between the symptoms. The symptoms presented by patients have certain individual differences and vary with the stage of treatment and treatment effect, which bring different degrees of distress to patients and their families and seriously affect patients' prognosis and quality of life. It is found that wound symptoms such as malodor are significantly negatively correlated with the quality of life of patients with malignant fungating wounds. Malignant fungating wounds cause patients' physical condition and social function to be severely restricted, and the cost of wound dressing change further increases financial pressure, which leads to low self-identity, complex and variable emotions, and low quality of life. With the continuous improvement of cancer treatment level, patients' quality of life is more representative of cure and recovery than survival to some extent. Therefore, the care of patients with malignant fungating wounds focuses on symptom management with the aim of improving the quality of life. There are scarce well-defined wound symptom management programs for this group, and most focus on wound management while ignoring the impact on the patient's body and mind. This study will take the symptom management theory as the guide, start from the actual needs of patients and combine with the actual clinical situation to construct malignant fungating wounds care regimen for breast cancer patients in order to improve the quality of life and make their lives dignified and meaningful.

Construction and Effect Evaluation of Malignant Fungating Wounds Care Regimen for Breast Cancer Patients

Construction and Effect Evaluation of Malignant Fungating Wounds Care Regimen for Breast Cancer Patients Based on Symptom Management Theory

Patients were counted to self-report the number and severity of wound bleeding in the recent 1-week period, the severity of wound bleeding was reported by the patient using a scale of 1\~10, and higher scores mean a more severe and frequent wound bleeding reported by patients in the last week.

described by "healing, improvement, maintenance, deterioration", where "wound healing" refers to 100% epithelialization of the wound, "wound improvement" refers to reduction of the wound area, "wound maintenance" refers to no change in the wound area, and "wound deterioration" refers to an increase in the wound area.

measured using the scale named "Toronto Symptom Assessment System for Wound(TSAS-W)"; the minimum and maximum values are 0 and 100 respectively, and higher scores mean a worse wound symptom reported by patients.

measured using the scale named "Quality of Life instruments for Cancer Patients-Breast Cancer(QLICP-BR)". There are 37 items, and 5\~10 and 27\~32 are positive entries, and the rest are reverse entries. Using Likert 5-level scoring method, the total score is 36\~180 points. The higher the total score, the better the quality of life. Only 35 items were used in this study.

measured using the scale named "Social Support Rate Scale(SSRS)".The scale includes 10 items and 3 dimensions, with a total score of 11-59. The higher the total score, the better the social support.

measured using the scale named "Self-rating Anxiety Scale(SAS)". SAS scale includes 20 items. If it is a positive scoring question, it will be rated as rough score 1, 2, 3 and 4 in turn; Reverse scoring questions (those with \* sign) will be rated as 4, 3, 2, 1 points. Add the scores of 20 items to get the rough score (x). Multiply the rough score by 1.25 and take the integer part to get the standard score (y). According to the results of the Chinese norm, the cut-off value of SAS standard deviation is 50 points, of which 50 \~ 59 points are mild anxiety, 60 \~ 69 points are moderate anxiety, and more than 70 points are severe anxiety.

measured using the scale named "Self-rating Depression Scale(SDS)". SDS scale includes 20 items and 10 positive scoring questions, which are rated as rough scores of 1, 2, 3 and 4 in turn; 10 reverse scoring questions (those with \* sign) will be rated as 4, 3, 2, 1 points. Add the scores of 20 items to get the rough score (x). Multiply the rough score by 1.25 and take the integer part to get the standard score (y). According to the results of the Chinese norm, the cut-off value of SDS standard score is 53 points, of which 53-62 points are mild depression, 63-72 points are moderate depression, and more than 73 points are severe depression.

measured using the scale named "Stigma Scale for Chronic Illness 8-item version(SSCI-8items)". The scale is developed on the basis of the 24 item stigma scale for chronic illness (SSCI), with a total of 8 items, of which 3 items are from internal shame, 5 items are from external shame, and all items are positive. The five options of the scale are: No, little, sometimes, often, always, and assigned 1, 2, 3, 4, and 5 points respectively, with a total score of 8 to 40 points. The higher the score, the higher the level of shame.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Benefits of Morphine Gel for Pain Reduction in Patients With Cancer Wounds	NCT05800834	Wounds and Inju... Cancer Pain Cancer, Breast Cancer Head Nec...	Morphine Sulfat... Lidocaine Hcl 2...	18 Years -	Instituto Nacional de Cancer, Brazil
Construction and Effect Evaluation of Malignant Fungating Wounds Care Regimen for Breast Cancer Patients	NCT05457309	Malignant Funga...	malignant funga...	18 Years -	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Spots Global Cancer Trial Database for malignant fungating wounds