Clinical trial · Interventional
Barrier Film vs. Standard Skin Care in Preventing Dermatitis in Women With Breast Cancer Receiving Radiation
Phase III Randomized Pair Comparison of a Barrier Film vs. Standard Skin Care in Preventing Radiation Dermatitis in Women With Breast Cancer Receiving Adjuvant Radiation Therapy
NCT01762020CI-TRIAL-00026343completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the effectiveness of preventing Grade II or greater radiation dermatitis induced by adjuvant radiation therapy in women with breast cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Dermatitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3M Cavilon No Sting Barrier Film | Device | — | UNRESOLVED |
| Standard Preparation | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 3M Cavilon No Sting Barrier Film
- description
- Two of four regions of the breast will be randomly chosen to receive 3M Cavilon No Sting Barrier Film treatment twice per week.
- interventionNames
- Device: 3M Cavilon No Sting Barrier Film
- type
- PLACEBO_COMPARATOR
- label
- Standard preparations
- description
- Standard treatment
- interventionNames
- Drug: Standard Preparation
Primary outcomes (1)
- measure
- Percent of patients developing modified Radiation Therapy Oncology Group(RTOG) Visual Assessment Score Grade II or greater radiation dermatitis induced by adjuvant radiation therapy in women with breast cancer
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients between 18 and 80 years of age at the time of enrollment * Histopathologically or cytologically confirmed diagnosis of breast cancer * Completed lumpectomy and sentinel lymph node biopsy or axillary lymph node dissection * Signed and dated ethics-approved informed consent form prior to any study procedures * Ability to comply with the requirements of the study * Scheduled adjuvant radiation therapy treatment Exclusion Criteria: * Clinical or radiological evidence of local recurrence or metastatic disease * Previous history of radiation therapy to ipsilateral axilla and/or breast area * Planned boost of radiation Dementia, psychoses, or other significant impairment of mental status that would prohibit the understanding and giving of informed consent or the participation in self-care or toxicity reporting * Any significant history or concurrent disease which, in the judgment of the Investigator would make the patient inappropriate for entry to this study * History of contraindications of radiation such as scleroderma
References
Publications (0)
Data not yet available
No reference posted for this study.