Clinical trial · Interventional
Trial of Blue Citrus Compared to Placebo in Patients Receiving Aromatase Inhibitor Therapy for Estrogen Receptor Positive Post-Menopausal Breast Cancer
Pilot, Single Center Randomized Controlled, Double-Blind, Cross Over, Intent to Treat Trial of Blue Citrus to Placebo in Those Breast Cancer Patients Receiving Aromatase Inhibitor Therapy
NCT00702858CI-TRIAL-00011945completedN/AClinicalTrials.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)
This purpose of this study is to determine if the herbal compound, Blue Citrus, decreases joint and bone pain associated with Aromotase Inhibitor therapy (AIT). Another purpose of the study is to find out if Blue Citrus improves how you feel while taking AIT and if your quality of life improves.
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 |
| Joint Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blue Citrus | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Blue Citrus either months 1-3 or 4-6
- interventionNames
- Drug: Blue Citrus
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- Placebo
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Determine if Blue Citrus decreases musculoskeletal symptoms while on AIT as compared to Placebo
- timeFrame
- 6 months
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Post Menopausal - evidenced by no menses for the past 6 months or FSH level \>40 2. Patient complaints of musculoskeletal symptoms 3. Currently taking AIT for ER positive postmenopausal breast cancer Exclusion Criteria: 1. Previously taken Blue Citrus 2. Presence of bone metastasis 3. Unable to complete VAS Pain Scale 4. Unable to comply/complete SF 12 Quality of Life survey 5. Plan to discontinue AIT in less then six months 6. Unable to complete ADL scale 7. Have diagnosis of fibromyalgia 8. Have diagnosis of rheumatoid arthritis
References
Publications (0)
Data not yet available
No reference posted for this study.