Comparing morphine gel and lidocaine gel for pain relief in 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
This study is testing whether morphine gel works better than lidocaine gel to relieve pain for people with cancer wounds on their breasts or head and neck.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto Nacional de Cancer, Brazil Government |
| Locations | 1 site (Rio De Janeiro) |
| Trial ID | NCT05800834 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of morphine gel compared to lidocaine gel in reducing pain for patients with malignant wounds, specifically in the breast and head/neck regions. Participants will be randomly assigned to receive either morphine or lidocaine gel, and their pain levels will be assessed through questionnaires before and after treatment over a three-day period. The study will ensure blinding for both patients and nurses to maintain objectivity in results. Monitoring visits will be conducted to ensure participant safety and data accuracy throughout the trial.
Who should consider this trial
Good fit: Ideal candidates include patients with malignant neoplastic wounds in the breast or head and neck regions who have a pain rating of at least 3 on a numerical scale.
Not a fit: Patients with wounds exhibiting extensive necrosis, ongoing radiotherapy, or other specific complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective pain management option for patients suffering from malignant wounds.
How similar studies have performed: Other studies have explored pain management in cancer patients, but this specific comparison of morphine gel versus lidocaine gel is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Rio De Janeiro
- National Cancer Institute — Rio De Janeiro, Brazil (Recruiting)
Study contacts
- Principal investigator: Daianny A de Oliveira da Cunha, MSc. — INCA Brazil
- Study coordinator: Daianny A de Oliveira da Cunha, MSc.
- Email: daoliveira@inca.gov.br
- Phone: +55 (21) 98118-4111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.