Back to resultsHigh Dose Vitamin D vs Standard Dose Vitamin D Study
Primary Purpose
Breast Cancer
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
800 IU Vitamin D Supplement
50,000 IU Vitamin D supplement
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Hormone Receptor Positive, Vitamin D
Eligibility 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.
Sites / Locations
- Washington University / Siteman Cancer Center
- Baylor College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High Dose Vitamin D ARM
800 IU Vitamin D Supplement
Arm Description
50,000 IU Vitamin D supplement
800 IU Vitamin D Supplement
Outcomes
Primary Outcome Measures
Number of Participants With Aromatase Inhibitor Induced Arthralgia (AIA) After 12 Weeks of Therapy
Aromatase Inhibitor Arthralgia (AIA) was assessed by a questionnaire that describe the level of pain experienced by the participant. The questionnaire asks 20 questions scored 0-3 in 8 categories of functioning: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. An average composite score on the HAQ-II was calculated. The visual analog scale is the other major component of the HAQ-II, which we ask patients to mark where their pain lies on a horizontal line and we converts the number into a score from 0 to 3. For the purposes of this study, AIA will be defined as any of the following criteria: 1) increase in HAQ-II score from baseline by 0.2 or greater; or 2) increase in visual analog pain score by 0.3 or greater.
Secondary Outcome Measures
Compliance With Anti-Cancer Treatment
We checked 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 52 weeks. A percentage of the number of pills were actually taken of the number of pills should be taken was calculated.
Association Between Vitamin D Levels Changes and Treatment.
Patients' serum 25-hydroxyvitamin D level were tested at baseline and week 12. The changes between baseline and week 12 were calculated.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01988090
Brief Title
High Dose Vitamin D vs Standard Dose Vitamin D Study
Official Title
A Randomized, Controlled Trial of High Dose vs. Standard Dose Vitamin D for Aromatase-Inhibitor Induced Arthralgia in Breast Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
An interim analysis demonstrated no benefit of high dose vitamin D when compared to standard dose vitamin D in the reduction or prevention of arthralgia
Study Start Date
December 2013 (Actual)
Primary Completion Date
July 21, 2018 (Actual)
Study Completion Date
December 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mothaffar Rimawi
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Hormone Receptor Positive, Vitamin D
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Dose Vitamin D ARM
Arm Type
Experimental
Arm Description
50,000 IU Vitamin D supplement
Arm Title
800 IU Vitamin D Supplement
Arm Type
Active Comparator
Arm Description
800 IU Vitamin D Supplement
Intervention Type
Drug
Intervention Name(s)
800 IU Vitamin D Supplement
Intervention Description
Standard Dose
Intervention Type
Drug
Intervention Name(s)
50,000 IU Vitamin D supplement
Intervention Description
High Dose
Primary Outcome Measure Information:
Title
Number of Participants With Aromatase Inhibitor Induced Arthralgia (AIA) After 12 Weeks of Therapy
Description
Aromatase Inhibitor Arthralgia (AIA) was assessed by a questionnaire that describe the level of pain experienced by the participant. The questionnaire asks 20 questions scored 0-3 in 8 categories of functioning: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. An average composite score on the HAQ-II was calculated. The visual analog scale is the other major component of the HAQ-II, which we ask patients to mark where their pain lies on a horizontal line and we converts the number into a score from 0 to 3. For the purposes of this study, AIA will be defined as any of the following criteria: 1) increase in HAQ-II score from baseline by 0.2 or greater; or 2) increase in visual analog pain score by 0.3 or greater.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Compliance With Anti-Cancer Treatment
Description
We checked 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 52 weeks. A percentage of the number of pills were actually taken of the number of pills should be taken was calculated.
Time Frame
52 Weeks
Title
Association Between Vitamin D Levels Changes and Treatment.
Description
Patients' serum 25-hydroxyvitamin D level were tested at baseline and week 12. The changes between baseline and week 12 were calculated.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Grip Strength
Description
Exploratory Endpoints For each patient on the study, grip strength will be correlated with AIA score using Spearman correlation at three time points throughout the study - baseline, week 12, and week 52.
Time Frame
52 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mothaffar Rimawi, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University / Siteman Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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High Dose Vitamin D vs Standard Dose Vitamin D Study
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