Retrospective Analysis of the Efficacy of Morphine Gel to Treat Pain Associated With Perineal RadioDermatitis

NCT07207889 | Completed

• 1 other identifier: DATA240316 ANTAGEL
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Retrospective study evaluating the efficacy of a pharmacy-prepared Morphine gel used in clinics for the treatment of pain associated with perineal radiodermatitis. The main aim of this study is to evaluate the efficacy of Morphine Gel (MG) in pain management.

Conditions

Dermatitis, Radiation Induced

Keywords

morphine gel; cutaneous toxicity

Outcome Measures

Primary Outcomes (1)

• Efficacy of morphine gel (GM) in the treatment of pain in perineal radiodermatitis

  Reduced pain as assessed by the patient. Verbal scale to qualify the evolution of the pain (decreased - stable - increased)

  between baseline and day2 to day21

Secondary Outcomes (2)

• Assessment of systemic analgesic prescribed

  between baseline and day2 to day 21

• Interruption of radiotherapy treatment in connection with radiodermatitis

  during 5 weeks from first day of radiotherapy (throught radiotherapy completion)

Study Arms (1)

Patients using morphine gel

patients who received morphine gel to treat pain due to perineal radiodermatitis

Drug: morphine chlorhydrate in intrasite gel

Interventions

morphine chlorhydrate in intrasite gel DRUG

The use of Morphine gel to treat painfull perineal radiodermatitis is new. None clinical study was conducted to explore the efficacy of the morphine gel as local analgesic for these cutaneous toxicity due to radiotherapy

Patients using morphine gel

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

17 patients who received Morphine gel for the treatment of pain associated with perineal radiodermatitis over a 20-month period between July 2022 and March 2024.

You may qualify if:

• Patients 18 years and older;
• Use of a local analgesic treatment based on Morphine gel for pain associated with perineal radiodermatitis.
• Patients not relieved by prescribed systemic treatments (per-os or intravenous)
• Patients treated with radiotherapy for a perineal tumor, whether or not associated with medical treatment such as chemotherapy.
• Minimum grade of radiodermatitis: Grade II

You may not qualify if:

• Patients who have not used the prescribed morphine gel
• Minor patients
• Patients using morphine gel for wounds other than radiodermatitis
• Patients who object to the re-use of their data

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (1)

Institut Curie

Paris, 75248, France

Location

MeSH Terms

Conditions

Radiodermatitis

Interventions

IntraSite Gel

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Study Officials

• Elodie LABEDADE

  Institut Curie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: October 6, 2025
• Study Start: December 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 6, 2025

Record last verified: 2025-04

Locations

FR (1)