Clinical trial · Interventional
Human Breast Tissue Bioavailability of Topically Applied Limonene
NCT01459172CI-TRIAL-00021882completedPhase 1ClinicalTrials.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 overall objective of this project is to determine the safety and breast tissue bioavailability of limonene following massage application of limonene containing massage oil to the breast.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| limonene containing massage oil | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Limonene intervention
- interventionNames
- Other: limonene containing massage oil
Primary outcomes (1)
- measure
- breast tissue bioavailability
- timeFrame
- 4 weeks
- description
- limonene levels in nipple aspirate fluid after 4 weeks of intervention
Secondary outcomes (1)
- measure
- safety
- timeFrame
- 6 weeks
- description
- number of participants with adverse events
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Women who are 18-65 years of age * ECOG performance status 0-1 * Normal organ and marrow function * Women of child-bearing potential must agree to use adequate contraception * Willing to avoid consumption and use of citrus or citrus containing products throughout the study * Have both breasts intact Exclusion Criteria: * Have had cancer(s) within the past 5 years * Participated in another clinical interventional trial within the past 3 months * Uncontrolled intercurrent illness * Pregnant or breast feeding * Unable to produce nipple aspirate fluid * Have known allergic or sensitive reactions to skin care products, citrus or coconut oil * Have ongoing skin disorders such as eczema and psoriasis
References
Publications (0)
Data not yet available
No reference posted for this study.