Trial of Blue Citrus Compared to Placebo in Patients Receiving Aromatase Inhibitor Therapy for Estrogen Receptor Positive Post-Menopausal Breast Cancer

Legacy Health System

Status: Completed

Conditions: Breast Cancer; Joint Pain

Treatments: Drug: Placebo; Drug: Blue Citrus

Study type: Interventional

Funder types: Other

Identifiers

NCT00702858

Blue Citrus BC-AIT-001

Details and patient eligibility

About

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.

Full description

Post-menopausal women currently on AIT for breast cancer treatment who self-report musculoskeletal side effects related to AIT to their physicians.

Enrollment: 30 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Blue Citrus either months 1-3 or 4-6

Treatment:

Drug: Blue Citrus

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo