NCT00867217

Brief Summary

The primary purpose is to determine if high dose vitamin D3 reduces the incidence of musculoskeletal symptoms associated with the aromatase inhibitor letrozole in women with early stage breast cancer and low serum vitamin D levels.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 23, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
7.1 years until next milestone

Results Posted

Study results publicly available

February 9, 2018

Completed
Last Updated

February 9, 2018

Status Verified

January 1, 2018

Enrollment Period

1.8 years

First QC Date

March 20, 2009

Results QC Date

March 14, 2016

Last Update Submit

January 11, 2018

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Worsening of Musculoskeletal Symptoms (MS)

    Worsening of Musculoskeletal Symptoms (MS) is defined as any one of the following three events: (a) an increase by at least 0.25 in the Health Assessment Questionnaire II (HAQ II, a measure of disability from joint pain) score, (b) an increase in patient reported severity of joint and/or muscle pain, or (c) discontinuation from trial prior to 24 weeks specifically because of problems with musculoskeletal symptoms.

    Change from Baseline to 24 Weeks

Study Arms (2)

High Dose Vitamin D

EXPERIMENTAL

High Dose Vitamin D3 capsule (3 x 10,000 IU capsules weekly). All subjects also received standard dose vitamin D3 (600 IU daily) and letrozole (2.5 mg daily).

Dietary Supplement: High Dose Vitamin DDietary Supplement: Standard Dose Vitamin D3Drug: Letrozole 2.5mg

Placebo

PLACEBO COMPARATOR

Placebo matched for High Dose Vitamin D3 capsules. All subjects also received standard dose vitamin D3 (600 IU daily) and letrozole (2.5 mg daily).

Dietary Supplement: PlaceboDietary Supplement: Standard Dose Vitamin D3Drug: Letrozole 2.5mg

Interventions

High Dose Vitamin DDIETARY_SUPPLEMENT

High Dose Vitamin D3 (3 capsules of 10,000 IU) weekly for 24 weeks.

High Dose Vitamin D
PlaceboDIETARY_SUPPLEMENT

Placebo comparator

Placebo
Standard Dose Vitamin D3DIETARY_SUPPLEMENT

Standard Dose Vitamin D3 (600 IU of vitamin D3 daily)

High Dose Vitamin DPlacebo
Letrozole 2.5mgDRUG

All subjects received letrozole as standard of care.

High Dose Vitamin DPlacebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Post-menopausal women newly diagnosed with early stage breast cancer, who would be treated with an aromatase inhibitor
  • Serum 25OHD levels \< 40 ng/ml

You may not qualify if:

  • Severe or debilitating musculoskeletal pain
  • Known metastatic disease
  • History of renal stones
  • History of hypercalcemia or hyperthyroidism
  • Currently receiving adjuvant or neoadjuvant chemotherapy
  • Currently receiving other investigational agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Kansas Medical Center

Westwood, Kansas, 66205, United States

Location

Cancer Centers of Kansas, P.A.

Wichita, Kansas, 67214, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Vitamin DCholecalciferolLetrozole

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholestenesCholestanesSterolsMembrane LipidsLipidsNitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Bruce Kimler
Organization
University of Kansas Medical Center
bkimler@kumc.edu
(913) 588-4523

Study Officials

  • Qamar J Khan, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 20, 2009

First Posted

March 23, 2009

Study Start

March 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

February 9, 2018

Results First Posted

February 9, 2018

Record last verified: 2018-01

Locations

US(2)