Clinical trial NCT00899288: Fingernails in Evaluating Bone Health in Postmenopausal Women With Breast Cancer Undergoing Hormone Therapy on Clinical Trial IBCSG-1-98
Official title: Investigating the Chemical Properties of Fingernails to Determine the Efficacy of Nail Structure for Evaluating Bone Fragility
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Breast Cancer
Osteoporosis
Keywords: osteoporosis
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
Lead sponsor: ETOP IBCSG Partners Foundation
Sponsor class: NETWORK
First posted: 2009-05-12
Enrollment: 60
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: RATIONALE: Studying samples of fingernails in the laboratory from patients with breast cancer may help in evaluating bone health in postmenopausal women undergoing hormone therapy for breast cancer.

PURPOSE: This laboratory study is examining fingernails as a way of evaluating bone health in postmenopausal women with breast cancer undergoing hormone therapy on clinical trial IBCSG-1-98.

Detailed description: OBJECTIVES:

Primary

* Compare the effects of tamoxifen vs letrozole on the chemical properties of fingernails by Raman spectroscopy in postmenopausal women with breast cancer undergoing adjuvant hormonal therapy on protocol IBCSG-1-98.
* Determine the efficacy of nail structure for evaluating bone fragility.

Secondary

* Compare fingernail assessments in patients who have had a bone fracture vs those who have not.
* Determine the natural variation in chemical (Raman spectroscopy) properties of 2 fingernails sourced at 1 appointment from the same donor.
* Evaluate the effect of further drug treatment (after 6 months) on the chemical properties of fingernails.

OUTLINE: This is a single-blind, multicenter, pilot study. Patients are stratified according to treatment on protocol IBCSG-1-98 (tamoxifen vs letrozole) and bone fracture (yes vs no).

Fingernail clippings are collected at baseline and 6 months later. Fingernail clippings are examined by Raman spectroscopy.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Enrolled on protocol IBCSG-1-98

  * Currently receiving (i.e., have not yet completed) 5 years of treatment with tamoxifen or letrozole and expected to receive ≥ 6 months of additional treatment on protocol IBCSG-1-98
* No recurrent breast cancer or second primary cancer
* No known bone disease (including osteomalacia or osteogenesis imperfecta)
* Hormone receptor status

  * Estrogen and/or progesterone receptor positive tumor

PATIENT CHARACTERISTICS:

* Female
* Postmenopausal
* No uncontrolled thyroid or parathyroid disease, Cushing's disease, or other pituitary diseases
* No malabsorption syndrome or clinically relevant vitamin D deficiency

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* More than 1 year since prior and no concurrent anticonvulsants
* More than 6 months since prior and no concurrent corticosteroids at doses \> the equivalent of 5 mg/day of prednisone for \> 2 weeks total
* No prior or concurrent sodium fluoride at daily doses ≥ 5 mg/day for \> 1 month
* More than 12 months since prior and no concurrent anabolic steroids
* More than 6 months since any prior drug for the prevention of osteoporosis (excluding calcium or cholecalciferol \[vitamin D\])
* Concurrent warfarin allowed provided duration of treatment is no more than 4 weeks

Primary outcomes:
measure: Determination of bone health using fingernail assessments at baseline and 6 months
timeFrame: At baseline and 6 months after inclusion in the trial
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Materials & Surface Science Institute at the University of Limerick
name: Mark Towler, MD
role: STUDY_CHAIR
References: