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

NCT05800834 | Unknown Phase 2 DMC

• 1 other identifier: 56160922.7.3001.5274
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Wounds and Injuries; Cancer Pain; Cancer, Breast; Cancer Head Neck

Keywords

Malignant fungating wounds; Painful wounds; Palliative care

Outcome Measures

Primary Outcomes (1)

• Numeric pain rating scale

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

  3 days

Secondary Outcomes (2)

• Pain relief

  3 days

• General Comfort Questionnaire

  3 days

Study Arms (2)

Morphine sulfate

EXPERIMENTAL

Topical morphine with hydrogel base.

Drug: Morphine Sulfate

Lidocaine Hcl 2% jelly

ACTIVE COMPARATOR

2% lidocaine jelly

Drug: Lidocaine Hcl 2% Jelly

Interventions

Morphine Sulfate DRUG

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.

Also known as: Dimorf

Morphine sulfate

Lidocaine Hcl 2% Jelly DRUG

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.

Also known as: Lidocaine gel

Lidocaine Hcl 2% jelly

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Nacional de Cancer, Brazil: lead

Study Sites (1)

National Cancer Institute

Rio de Janeiro, 20560121, Brazil

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries; Cancer Pain; Breast Neoplasms; Head and Neck Neoplasms

Interventions

Morphine; Lidocaine; Gels

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Daianny A de Oliveira da Cunha, MSc.

  INCA Brazil

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daianny A de Oliveira da Cunha, MSc.

CONTACT

+55 (21) 98118-4111; daoliveira@inca.gov.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 6, 2023
• Study Start: September 12, 2023
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)