Clinical trial · Interventional
Study of the Safety and Efficacy of a Caffeine-based Antifibrosis Cream in Patients With Breast Cancer Undergoing Radiation Therapy
A Phase 1, Randomized, Double Blinded, Placebo Controlled Study of the Safety and Efficacy of a Caffeine-based Antifibrosis Cream in Patients With Breast Cancer Undergoing Radiation Therapy
NCT03768492CI-TRIAL-00113598ReDCoATactive not recruitingPhase 2ClinicalTrials.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)
The purpose of the study is to evaluate whether a caffeine-based cream can reduce the rates of reconstructive complications in patients with tissue expander based reconstruction requiring post-mastectomy radiation therapy when compared to a placebo cream.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma Breast | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Caffeine anhydrous 5% added to Lipoderm Cream Base. | Drug | — | UNRESOLVED |
| Lipoderm Cream Base | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Caffeine Based Cream
- description
- caffeine based cream during and for 4 weeks following radiation
- interventionNames
- Drug: Caffeine anhydrous 5% added to Lipoderm Cream Base.
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- placebo cream during and for 4 weeks following radiation
- interventionNames
- Other: Lipoderm Cream Base
Primary outcomes (1)
- measure
- Standard Toxicity Scoring
- timeFrame
- 4 Years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient has histologically-confirmed carcinoma of breast (all subtypes are permitted) * Patient has undergone mastectomy with tissue expander-based reconstruction and require post-mastectomy radiation therapy (PMRT) per the - Stage DCIS (0) -III breast cancer, excluding any patients with inflammatory breast cancer at presentation. * Patient will receive irradiation of the chest wall. Additional fields to treat the regional nodes including the supraclavicular / axillary and/or internal mammary chains is allowed but not required. If a patient requires a boost field to the chest wall, scar and/or nodal region this is allowed. Exclusion Criteria: * Patient with skin changes or inflammatory carcinoma at presentation Patient has (cT4b-d) * unhealed wound in the radiation field * Patient has allergy to Caffeine * Patient has systemic lupus erythematosus or scleroderma that increases the risk of radiation dermatitis development * Patient will receive concurrent chemotherapy with radiation. (Patient is allowed to take concurrent hormonal therapy or Trastuzumab) * Planned accelerated or hypofractionated fractionation. * Previous radiation to the ipsilateral breast or chest wall or thoracic region. * Anyone who will require bolus use during radiation (per physician discretion) as this will increase rates of acute toxicity interfering with measurement of the primary study endpoint. * All pre-menopausal women will require a urine qualitative pregnancy test to exclude pregnancy. Pregnant women will be excluded from the study.
References
Publications (0)
Data not yet available
No reference posted for this study.