High Dose Vitamin D vs Standard Dose Vitamin D Study

• ClinicalTrials.gov Identifier: NCT01988090
• Recruitment Status: Terminated
• First Posted: November 20, 2013
• Results First Posted: March 19, 2019
• Last Update Posted: August 9, 2021
• Sponsor: Mothaffar Rimawi
• Information provided by (Responsible Party): Mothaffar Rimawi, Baylor Breast Care Center

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).

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: 800 IU Vitamin D Supplement; Drug: 50,000 IU Vitamin D supplement	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 93 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Actual Study Start Date: December 2013
• Actual Primary Completion Date: July 21, 2018
• Actual Study Completion Date: December 10, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: High Dose Vitamin D ARM; 50,000 IU Vitamin D supplement	Drug: 50,000 IU Vitamin D supplement; High Dose
Active Comparator: 800 IU Vitamin D Supplement; 800 IU Vitamin D Supplement	Drug: 800 IU Vitamin D Supplement; Standard Dose

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Aromatase Inhibitor Induced Arthralgia (AIA) After 12 Weeks of Therapy [ Time Frame: 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 :

1. Compliance With Anti-Cancer Treatment [ Time Frame: 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.
2. Association Between Vitamin D Levels Changes and Treatment. [ Time Frame: 12 weeks ]
   Patients' serum 25-hydroxyvitamin D level were tested at baseline and week 12. The changes between baseline and week 12 were calculated.

Other Outcome Measures:

1. Grip Strength [ Time Frame: 52 weeks ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes 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

Locations

United States, Missouri

Washington University / Siteman Cancer Center

Saint Louis, Missouri, United States, 63110

United States, Texas

Baylor College of Medicine

Houston, Texas, United States, 77030

Sponsors and Collaborators

Mothaffar Rimawi

Investigators

• Principal Investigator: Mothaffar Rimawi, MD; Baylor College of Medicine

  Study Documents (Full-Text)

Documents provided by Mothaffar Rimawi, Baylor Breast Care Center:

Study Protocol and Statistical Analysis Plan  [PDF] July 14, 2015

More Information

• Responsible Party: Mothaffar Rimawi, Professor, Baylor Breast Care Center
• ClinicalTrials.gov Identifier: NCT01988090
• Other Study ID Numbers: H-33261
• First Posted: November 20, 2013
• Results First Posted: March 19, 2019
• Last Update Posted: August 9, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Mothaffar Rimawi, Baylor Breast Care Center:

Breast Cancer; Hormone Receptor Positive; Vitamin D

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins; Micronutrients; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents