Vitamin D Deficiency, Muscle Pain, Joint Pain, and Joint Stiffness in Postmenopausal Women Receiving Letrozole For Stage I-III Breast Cancer

NCT00416715 | Completed Phase 2 Results

• 2 other identifiers: 6346NCI-2010-00621
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying vitamin D deficiency, muscle pain, joint pain, and joint stiffness in postmenopausal women receiving letrozole for stage I-III breast cancer. Learning about vitamin D deficiency and muscle pain, joint pain, and joint stiffness in patients receiving letrozole for breast cancer may help doctors plan treatment and may help patients live more comfortably

Conditions

Arthralgia; Musculoskeletal Complications; Pain; Recurrent Breast Cancer; Stage I Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Early Breast Cancer Patients Prescribed Adjuvant Letrozole That Are Vitamin D Deficient and Who Experience Myalgias, Arthralgias and/or Joint Stiffness

  Count of early breast cancer patients prescribed adjuvant letrozole that are vitamin D deficient and who experience myalgias, arthralgias and/or joint stiffness, assessed at baseline and 1 month after vitamin D repletion.

  Baseline and 1 month post vitamin D repletion

Secondary Outcomes (1)

• Letrozole Serum Levels Before and After Vitamin D Repletion

  Baseline and 1 month post vitamin D repletion

Study Arms (1)

Treatment (letrozole)

EXPERIMENTAL

Patients receive letrozole PO QD. Patients, who experience muscle pain, joint pain, or joint stiffness that requires an intervention and who are found to be vitamin D deficient, also receive calcium and vitamin D3 PO. Treatment continues for up to 28 weeks in the absence of disease progression or unacceptable toxicity.

Drug: letrozole; Dietary Supplement: calcium carbonate; Other: laboratory biomarker analysis; Dietary Supplement: calcium citrate; Dietary Supplement: calcium glucarate; Drug: calcium gluconate; Dietary Supplement: cholecalciferol; Procedure: assessment of therapy complications; Procedure: musculoskeletal complications management/prevention

Interventions

letrozole DRUG

Given PO

Also known as: CGS 20267, Femara, LTZ

Treatment (letrozole)

calcium carbonate DIETARY_SUPPLEMENT

Given PO

Also known as: CaCO3

Treatment (letrozole)

laboratory biomarker analysis OTHER

Optional correlative studies

Treatment (letrozole)

calcium citrate DIETARY_SUPPLEMENT

Given PO

Also known as: Acicontral, CALCIT, Citracal, Tricalcium Citrate

Treatment (letrozole)

calcium glucarate DIETARY_SUPPLEMENT

Given PO

Also known as: antacidin, calcium D-glucarate, calcium D-saccharate, CGT

Treatment (letrozole)

calcium gluconate DRUG

Given PO

Also known as: Calcium D-gluconate, CALGLUC, Calglucon

Treatment (letrozole)

cholecalciferol DIETARY_SUPPLEMENT

Given PO

Also known as: Calciol, Vitamin D3

Treatment (letrozole)

assessment of therapy complications PROCEDURE

Ancillary studies

Treatment (letrozole)

musculoskeletal complications management/prevention PROCEDURE

Correlative studies

Also known as: complications management/prevention, musculoskeletal, management/prevention, musculoskeletal complications

Treatment (letrozole)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a histologically confirmed diagnosis of Stage I, II or III breast carcinoma
• Patients must be prescribed letrozole for adjuvant breast cancer treatment
• Prior adjuvant tamoxifen is permitted
• Patients must be postmenopausal; for study purposes, postmenopausal is defined as: a prior documented bilateral oophorectomy, or a history of at least 12 months without spontaneous menstrual bleeding, or have a persistently postmenopausal estradiol in the past 6 months without menses, and clinically in menopause at the judgment of the treating physician, or age 60 or older with a prior hysterectomy without oophorectomy, or age less than 60 with a prior hysterectomy without oophorectomy (or in whom the status of the ovaries is unknown), with a documented FSH level demonstrating confirmatory elevation in the postmenopausal range for the lab

You may not qualify if:

• Diagnosis of Stage IV breast carcinoma
• Pre-existing myalgias, arthralgias and/or joint stiffness \>= Grade 1, as defined using CTEP CTC identified during baseline physical exam
• Inability to understand or cooperate with study procedures
• Receipt of investigational drug within 30 days before study entry
• Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
• Unwillingness to give informed consent
• Unwillingness to participate or inability to comply with the protocol for the duration of the study
• Patients with serum calcium \>= 14 mg/dL
• Patients with renal dysfunction defined as glomerular filtration rate \<10ml/min calculated using Cockroft-Gault equation

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Arthralgia; Pain; Breast Neoplasms

Interventions

Letrozole; Calcium Carbonate; Calcium Citrate; Glucaric Acid; Calcium Gluconate; Calcium; Cholecalciferol; Therapeutics

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals; Citric Acid; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Sugar Acids; Hydroxy Acids; Carbohydrates; Gluconates; Metals, Alkaline Earth; Elements; Metals; Blood Coagulation Factors; Biological Factors; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Dr. Hannah Linden
• Organization: University of Washington / Seattle Cancer Care Alliance

hmlinden@uw.edu

206-288-6989

Study Officials

• Hannah Linden

  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 27, 2006
• First Posted: December 28, 2006
• Study Start: October 1, 2006
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: July 11, 2017
• Results First Posted: July 11, 2017

Record last verified: 2017-06

Locations

US (1)