ArthralgiaPhase 2NCT00416715
Vitamin D Deficiency, Muscle Pain, Joint Pain, and Joint Stiffness in Postmenopausal Women Receiving Letrozole For Stage I-III Breast Cancer
A Phase 2 study testing letrozole, calcium carbonate and laboratory biomarker analysis in people with Arthralgia and Musculoskeletal Complications, run by University of Washington at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Arthralgia, Musculoskeletal Complications, Pain
- What is being tested?
- letrozole, calcium carbonate and laboratory biomarker analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to May 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: A Pilot Study of Vitamin D Deficiency and Myalgias, Arthralgias and/or Joint Stiffness Associated With Letrozole (Femara® )
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
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the rate of vitamin D deficiency in breast cancer patients who experience myalgias, arthralgias and/or joint stiffness following initiation of adjuvant letrozole treatment.
SECONDARY OBJECTIVES:
- To determine if there is a correlation between letrozole serum levels and the development of myalgias, arthralgias and/or joint stiffness.
II. To assess if vitamin D supplementation may alleviate myalgias, arthralgias and/or joint stiffness associated with letrozole in those subjects with vitamin D deficiency.
OUTLINE:
Patients receive letrozole orally (PO) once daily (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 PO and vitamin D3 PO. Treatment continues for up to 28 weeks in the absence of disease progression or unacceptable toxicity.
- Conditions
- Arthralgia, Musculoskeletal Complications, Pain, Recurrent Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer
- Being tested
- letrozole, calcium carbonate, laboratory biomarker analysis, calcium citrate, calcium glucarate
- Medical subject headings
- Arthralgia, Pain, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
letrozoleDrug
Also called CGS 20267, Femara, LTZ
Given PO
calcium carbonateDietary supplement
Also called CaCO3
Given PO
laboratory biomarker analysisOther
Optional correlative studies
calcium citrateDietary supplement
Also called Acicontral, CALCIT, Citracal, Tricalcium Citrate
Given PO
calcium glucarateDietary supplement
Also called antacidin, calcium D-glucarate, calcium D-saccharate, CGT
Given PO
calcium gluconateDrug
Also called Calcium D-gluconate, CALGLUC, Calglucon
Given PO
cholecalciferolDietary supplement
Also called Calciol, Vitamin D3
Given PO
assessment of therapy complicationsProcedure or surgery
Ancillary studies
musculoskeletal complications management/preventionProcedure or surgery
Also called complications management/prevention, musculoskeletal, management/prevention, musculoskeletal complications
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 1 month post vitamin D repletion
Secondary outcomes (1)
Letrozole Serum Levels Before and After Vitamin D Repletion
Letrezole serum level concentration in patients that were vitamin D deficient and experienced myalgias, arthralgias and/or joint stiffness.
Measured: Baseline and 1 month post vitamin D repletion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2006 (estimated)
- Study startOct 2006
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ArthralgiaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Hannah Linden, University of Washington
- Investigators
- Hannah Linden, Principal investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00416715
- Sponsor's protocol ID
- 6346
- Other IDs
- NCI-2010-00621
- Status last verified
- Jun 2017
- First submitted
- 27 Dec 2006
- Last updated
- 11 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Vitamin D Deficiency and Myalgias, Arthralgias and/or Joint Stiffness Associated With Letrozole (Femara® )
- ClinicalTrials.gov ID
- NCT00416715
- Acronym / sponsor ID
- 6346
- Conditions
- Arthralgia, Musculoskeletal Complications, Pain, Recurrent Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2006
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 28 Dec 2006 (estimated)
- Results
- Posted 11 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
PRIMARY OBJECTIVES:
- To assess the rate of vitamin D deficiency in breast cancer patients who experience myalgias, arthralgias and/or joint stiffness following initiation of adjuvant letrozole treatment.
SECONDARY OBJECTIVES:
- To determine if there is a correlation between letrozole serum levels and the development of myalgias, arthralgias and/or joint stiffness.
II. To assess if vitamin D supplementation may alleviate myalgias, arthralgias and/or joint stiffness associated with letrozole in those subjects with vitamin D deficiency.
OUTLINE:
Patients receive letrozole orally (PO) once daily (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 PO and vitamin D3 PO. Treatment continues for up to 28 weeks in the absence of disease progression or unacceptable toxicity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (letrozole) | Experimental | 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/preventionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| letrozoleAlso: CGS 20267, Femara, LTZGiven PO | Drug | Treatment (letrozole) |
| calcium carbonateAlso: CaCO3Given PO | Dietary supplement | Treatment (letrozole) |
| laboratory biomarker analysisOptional correlative studies | Other | Treatment (letrozole) |
| calcium citrateAlso: Acicontral, CALCIT, Citracal, Tricalcium CitrateGiven PO | Dietary supplement | Treatment (letrozole) |
| calcium glucarateAlso: antacidin, calcium D-glucarate, calcium D-saccharate, CGTGiven PO | Dietary supplement | Treatment (letrozole) |
| calcium gluconateAlso: Calcium D-gluconate, CALGLUC, CalgluconGiven PO | Drug | Treatment (letrozole) |
| cholecalciferolAlso: Calciol, Vitamin D3Given PO | Dietary supplement | Treatment (letrozole) |
| assessment of therapy complicationsAncillary studies | Procedure or surgery | Treatment (letrozole) |
| musculoskeletal complications management/preventionAlso: complications management/prevention, musculoskeletal, management/prevention, musculoskeletal complicationsCorrelative studies | Procedure or surgery | Treatment (letrozole) |
Primary outcome
Number of Early Breast Cancer Patients Prescribed Adjuvant Letrozole That Are Vitamin D Deficient and Who Experience Myalgias, Arthralgias and/or Joint Stiffness
Time frame: Baseline and 1 month post vitamin D repletion
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.
1 secondary outcome
Letrozole Serum Levels Before and After Vitamin D Repletion
Time frame: Baseline and 1 month post vitamin D repletion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannah Linden principal investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing letrozole, calcium carbonate and laboratory biomarker analysis in people with Arthralgia and Musculoskeletal Complications, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Early Breast Cancer Patients Prescribed Adjuvant Letrozole That Are Vitamin D Deficient and Who Experience Myalgias, Arthralgias and/or Joint Stiffness (time frame: Baseline and 1 month post vitamin D repletion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.