High Dose Vitamin D vs Standard Dose Vitamin D Study

Phase 2

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: 50,000 IU Vitamin D supplement; Drug: 800 IU Vitamin D Supplement

• Registration Number: NCT01988090
• Lead Sponsor: Mothaffar Rimawi

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.

Study Timeline

• Study First Submitted: 2013-11-07
• Study First Submitted QC: 2013-11-13
• Study First Posted: 2013-11-20
• Study Start: 2013-12
• Primary Completion: 2018-07-21
• Study Completion: 2018-12-10
• Results First Submitted: 2019-01-31
• Results First Submitted QC: 2019-02-28
• Results First Posted: 2019-03-19
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-05
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 93

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Dose Vitamin D ARM	50,000 IU Vitamin D supplement	50,000 IU Vitamin D supplement
800 IU Vitamin D Supplement	800 IU Vitamin D Supplement	800 IU Vitamin D Supplement

Primary Outcome Measures

Name	Time	Method
Number of Participants With Aromatase Inhibitor Induced Arthralgia (AIA) After 12 Weeks of Therapy	12 weeks	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

Name	Time	Method
Association Between Vitamin D Levels Changes and Treatment.	12 weeks	Patients' serum 25-hydroxyvitamin D level were tested at baseline and week 12. The changes between baseline and week 12 were calculated.
Compliance With Anti-Cancer Treatment	52 Weeks	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.

Trial Locations

Locations (2)

Washington University / Siteman Cancer Center; 🇺🇸 Saint Louis, Missouri, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States