Fingernails in Evaluating Bone Health in Postmenopausal Women With Breast Cancer Undergoing Hormone Therapy on Clinical Trial IBCSG-1-98

Breast Cancer Clinical Trial

Official title:

Investigating the Chemical Properties of Fingernails to Determine the Efficacy of Nail Structure for Evaluating Bone Fragility

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00899288
• Other study ID #: CDR0000482403
• Secondary ID: IBCSG-18-98-FPSI
• Status: Terminated
• Phase: Phase 3
• First received: May 9, 2009
• Last updated: July 26, 2012
• Start date: April 2005
• Est. completion date: July 2007

Study information

• Verified date: July 2012
• Source: International Breast Cancer Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Osteoporosis

Intervention

Procedure:
• spectroscopy
Nails will be chemically characterized using Raman spectroscopy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
International Breast Cancer Study Group

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of bone health using fingernail assessments at baseline and 6 months		At baseline and 6 months after inclusion in the trial	No