Vitamin D3 Effects on Musculoskeletal Symptoms With Use of Aromatase Inhibitors

H

HealthPartners Institute

Status and phase

Completed
Phase 2

Conditions

Joint Pain
Muscle Pain

Treatments

Drug: Vitamin D3

Study type

Interventional

Funder types

Other

Identifiers

NCT01509079
03962-10C

Details and patient eligibility

About

The Purpose of this study is to determine whether vitamin D3 supplements will decrease the muscle and bone pain that are reported by women who take Aromatase Inhibitors.

Full description

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.

Enrollment

116 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

116 participants in 2 patient groups

Vitamin D3 4000 IU
Experimental group
Treatment:
Drug: Vitamin D3
Vitamin D3 600 IU
Active Comparator group
Treatment:
Drug: Vitamin D3

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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