Trial record 4 of 1132 for:    Open Studies | vitamins

High Dose Vitamin D vs Standard Dose Vitamin D Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Baylor Breast Care Center
Sponsor:
Information provided by (Responsible Party):
Baylor Breast Care Center
ClinicalTrials.gov Identifier:
NCT01988090
First received: November 7, 2013
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

This study is being done to look at the difference, if there is a difference between two different doses of Vitamin D and the reduction of joint/muscle pain (arthralgia)that is caused by taking anti-estrogen medications (aromatase inhibitors) by breast cancer patients. The investigators hope to learn if taking a higher dose of Vitamin D is a good way to prevent aromatase inhibitor arthralgia (AIA).


Condition Intervention Phase
Breast Cancer
Drug: 800 IU Vitamin D Supplement
Drug: 50,000 IU Vitamin D supplement
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Trial of High Dose vs. Standard Dose Vitamin D for Aromatase-Inhibitor Induced Arthralgia in Breast Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Baylor Breast Care Center:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 52 Weeks / 5 years ] [ Designated as safety issue: No ]

    The primary endpoint for this study is development of Aromatase Inhibitor Arthralgia (AIA) in each arm after 12 weeks of AI therapy. We will measure this by using patient questionnaires that describe the level of AIA pain experienced by the participant. We will also measure the grip strength of the patients enrolled.

    At five years, we will compare breast cancer recurrence rates in each arm to see if there is a difference between those patients that had less pain and stayed on their aromatase inhibitor therapy.



Secondary Outcome Measures:
  • Compliance with Anti-Cancer Treatment [ Time Frame: 52 Weeks ] [ Designated as safety issue: Yes ]

    We will check compliance of aromatase inhibitor therapy during the study by reviewing the patient's use of AI drug. This will be done by counting remaining pills in patient's bottles of AI at weeks 12, 24, 36, and 52 weeks. Compliance rate over 52 weeks of AI therapy will be compared between the two arms using longitudinal data analysis.

    We will test the participant's blood to see if there is an association between low baseline vitamin D levels and AIA (aromatase inhibitor arthralgia / pain).



Other Outcome Measures:
  • Number of patients that have improved grip strength due to less pain [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
    Exploratory Endpoints For each patient on the study, grip strength will be correlated with AIA score using logistic regression analysis and Spearman correlation at three time points throughout the study - baseline, week 12, and week 52.


Estimated Enrollment: 184
Study Start Date: December 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Dose Vitamin D ARM
50,000 IU Vitamin D supplement
Drug: 50,000 IU Vitamin D supplement
High Dose
Other Name: 50,000 IU Vitamin D supplement
Active Comparator: 800 IU Vitamin D Supplement
800 IU Vitamin D Supplement
Drug: 800 IU Vitamin D Supplement
Standard Dose
Other Name: 800 IU Vitamin D Supplement

Detailed Description:

Treatments with anti-estrogen agents for hormone receptor positive breast cancer is the most efficacious of systemic therapies, with aromatase inhibitors (AI's) being considered the most active anti-estrogen therapy in early stage breast cancer. But, use of these treatments has been shown to cause musculoskeletal (joint/muscle) side effects that sometimes cause patients to discontinue the use of them. Also, Vitamin D deficiency is a well know cause of a wide array of musculoskeletal issues. There is evidence that Vitamin D supplementation may help prevent arthralgia while on AI's. Therefore, the investigators want to see if giving a higher dose of Vitamin D could decrease the incidence of AIA as compared to a standard dose of Vitamin D. The investigators believe that this could possibly result in patients continued treatment with AI therapy for hormone receptor positive breast cancer.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All participants must be female and at least 21 years of age
  • Signed informed consent
  • Patients must have had histologically confirmed stage I-III breast carcinoma that is positive for Estrogen Receptor (ER) and/or Progesterone Receptor (PR).
  • Post-menopausal
  • Beginning adjuvant aromatase inhibitor therapy, with no previous use within the last 6 weeks
  • Bisphosphonates are allowed at the treating investigator¡¦s discretion
  • Performance status (WHO/ECOG scale) 0-2.

Exclusion Criteria:

  • History of kidney stones
  • Hypercalcemia at baseline, defined as any corrected calcium greater than the laboratory's normal parameters
  • History of either symptomatic hypercalcemia or hyperparathyroidism, at the treating investigator's discretion
  • Baseline Vitamin D level greater than 50 ng/mL
  • Inability or unwillingness to comply with, or follow study procedures.
  • Currently taking Phenytoin or phenobarbital -7 Currently taking cholestyramine or orlistat
  • Malabsorption syndrome, such as Crohn's disease

Prohibited Therapies: Patients may not take additional Calcium and Vitamin D aside from the study medications. Patients who are on cholestyramine or orlistat will not be allowed on the trial. Also, patients who are taking phenytoin or phenobarbital are not allowed on the trial either because of interaction between Vitamin D and anti-epileptic medications.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01988090

Contacts
Contact: Claudette Foreman, Sr. CRC 713-798-7315 caforema@bcm.edu
Contact: Kristen Otte, BS 713-798-8874 kristen.otte@bcm.edu

Locations
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Brenda Reusser, B.A.    713-798-1929    breusser@bcm.edu   
Sub-Investigator: Julie Nangia, MD         
Sub-Investigator: Mothaffar Rimawi, MD         
Sub-Investigator: C. Kent Osborne, MD         
Sub-Investigator: Sao Jiralerspong, M.D.         
Sponsors and Collaborators
Baylor Breast Care Center
Investigators
Principal Investigator: Polly Niravath, MD Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Baylor Breast Care Center
ClinicalTrials.gov Identifier: NCT01988090     History of Changes
Other Study ID Numbers: H-33261
Study First Received: November 7, 2013
Last Updated: May 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Baylor Breast Care Center:
Breast Cancer
Hormone Receptor Positive
Vitamin D

Additional relevant MeSH terms:
Vitamin D
Vitamins
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Ergocalciferols
Aromatase Inhibitors
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014