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Phase 2
18 Years
N/A
Open (Enrolling)
Female
Muscle Pain, Joint Pain

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Trial Information


This project will determine the efficacy of vitamin D3 supplements for reducing side effects
of treatment with aromatase inhibitors in women with a history of breast cancer that have no
evidence of current disease. The aromatase inhibitors (AI) have become a critical
component of adjuvant therapy for this population, but they cause bone pain, joint pain,
joint stiffness, and muscle weakness in approximately 40% of patients. These symptoms,
referred to as aromatase inhibitor-associated musculoskeletal symptoms (AIMSS), decrease
quality of life and medication adherence. Identifying effective ways to decrease these
symptoms may allow for longer and more adherent medication use and thus may improve
disease-free survival. We hypothesize that vitamin D3 may decrease symptoms associated with
the use of aromatase inhibitors.


Inclusion Criteria:



- Age ≥ 18 years

- Women with a history of stage I-IIIa invasive breast cancer

- History of hormone-receptor positive cancer (either ER + or PR + or both)

- Are prescribed and are taking anastrozole, letrozole or exemestane for at least one
month and have at least 7 months of AI treatment remaining

- Are experiencing AIMSS

Exclusion Criteria:

- Unable to read or understand English

- History of psychiatric disability affecting informed consent or compliance with drug
intake

- Malabsorption syndrome or inability to take oral medication

- Has less than 7 months of AI therapy remaining

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Musculoskeletal symptoms on the BCPT symptom scale

Outcome Time Frame:

Change from baseline to 6 months

Safety Issue:

No

Principal Investigator

Alice C. Shapiro, PhD RD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Park Nicollet Health Services

Authority:

United States: Institutional Review Board

Study ID:

03962-10C

NCT ID:

NCT01509079

Start Date:

March 2012

Completion Date:

September 2014

Related Keywords:

  • Muscle Pain
  • Joint Pain
  • Arthralgia

Name

Location

Park Nicollet Frauenshuh Cancer CenterMinneapolis, Minnesota  55416