Newly Diagnosed Operative Invasive Ductal Breast Carcinoma Stage I-IIPhase 1NCT01816555
Vitamin D3 (Vit D3) Supplementation and T Cell Immunomodulation in Patients With Newly Diagnosed Operative Invasive Ductal Breast Carcinoma
A Phase 1 study testing Vitamin D in people with Newly Diagnosed Operative Invasive Ductal Breast Carcinoma Stage I-II, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This study is for adult females who have been newly diagnosed with breast cancer that includes surgery as part of standard cancer treatment. This is a research study combining Vitamin D (an over the counter medication) with the standard of care (or the established and approved treatment), surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Newly Diagnosed Operative Invasive Ductal Breast Carcinoma Stage I-II
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Nov 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be greater than or equal to 18 years of age.
- Patients must have a newly diagnosed invasive ductal breast carcinoma, Stage I-II.
- Patients who have completed their surgical and radiation therapy.
- Patients must have SWOG performance status of 0, 1 or 2.
- Patients must have adequate organ function as defined by:
- Hgb > 8.0 gm/dl, WBC > 3,500, platelet count > 100,000
Show all 12Show fewer
- Bilirubin < 2.0 mg/dl, SGOT < 4x upper limit of normal
- Creatinine < 2.0 mg/dl or calculated creatinine clearance > 50 ml/min
- Patients must have a serum calcium - phosphate product that is less than 70.
- Patients must have recovered from any prior surgery.
- Patients must be willing to use appropriate contraception if of child-bearing potential.
- Patients may be on standard of care maintenance dose Vit D3
Who cannot join
- Patients with histology of lobular carcinoma.
- Patients with metastatic disease.
- Pregnant or lactating women.
- Male gender.
- Patients with a history of sarcoidosis.
- Patients with any history of idiopathic urinary calcium stone disease, chronic hypercalcemia, or gastrointestinal malabsorptive conditions.
Show all 21Show fewer
- Patients who have received any of the following treatments within the last 14 days prior to study registration will be excluded.
- Lithium
- Digitalis
- Thiazide diuretics
- Calcium supplementation during 1,25-dihydroxyvitamin D3 treatment
- Bisphosphonates
- Teriparatide
- Aluminum Hydroxide
- Bile Acid sequestrants
- Repletion dose VitD3 in setting of known Vit D3 deficiency or insufficiency
- Patients who have received concurrent corticosteroid treatments within the last 14 days prior to study registration will be excluded.
- Known HIV positive.
- Patients with an active infection requiring antibiotic therapy.
- Other malignancies unless the patient is considered to be disease-free for 5 or more years prior to randomization and is deemed by her physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
- Patients undergoing neoadjuvant chemotherapy or neoadjuvant endocrine therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Vitamin D3 (Vit D3) Supplementation and T Cell Immunomodulation in Patients With Newly Diagnosed Operative Invasive Ductal Breast Carcinoma Stage I-II
This study is for adult females who have been newly diagnosed with breast cancer that includes surgery as part of standard cancer treatment. This is a research study combining Vitamin D (an over the counter medication) with the standard of care (or the established and approved treatment), surgery. Evidence shows that women who are Vitamin D3 deficient have a higher risk of breast cancer and breast cancer recurrence. The purpose of this study is to find out the effects of Vitamin D3 during the treatment period for Stage I-II breast cancer. Screening tests will be done to determine if subjects are eligible to participate in this study. If subjects are eligible and they agree to participate, they will be assigned to one of two groups which will receive different amounts of vitamin D. Subjects will be asked to keep a medication diary. Subjects may remain on treatment for approximately 56 days.
- Being tested
- Vitamin D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Subjects will be assigned to a dosage level between 600IU daily and 10,000IU daily depending on their age, weight and current vitamin D level
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D- Normal Level at Screening | Experimental | Subjects will have surgery as their initial breast therapy. If subjects have a normal level of Vitamin D(25-hydroxyVit D 30-100ng/mL), they will be assigned to this group. Receives: Dietary Supplement: Vitamin D |
| Vitamin D- Insufficient or Deficient Level at Screening | Experimental | Subjects will have surgery as their initial breast therapy. If subjects are insufficient (25-hydroxy Vit D 21-29 ng/mL)or deficient (25-hydroxyVit D <20ng/mL) Vitamin D levels, they will be assigned to this group. Receives: Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the differences in the T cell phenotype and function using PBMCs from patients in different cohorts
T cell analysis for the following markers will be evaluated-
- memory markers
- activation status and presence of regulatory T cells
- lymphoid organ-homing receptors
- Functional status of gated T cells will be analyzed
- cell surface thiol molecules and intracellular glutathione using flow cytometry to evaluate if anti-oxidant stus of the T cells is modulated in presence of the Vitamin D.
These markers will help in determining the immunomodulatory potential of Vitamin D on T cell with respect to function, activation status and anti-oxidant capacity that can effect persistence and in turn immune outcome. The data obtained will be reported in terms of percent increase or decrease in number of T cells expressing particular receptors (homing or chemokine) or for differences in functional outcome (cytokine response) upon activation relative to samples collected at baseline.
Measured: Prior to Treatment (Baseline), Week 4 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionNov 2014
- Study completionNov 2014
Why it stopped: Study closed due to low accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed Operative Invasive Ductal Breast Carcinoma Stage I-IIStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816555
- Sponsor's protocol ID
- 101813
- Status last verified
- Aug 2014
- First submitted
- 6 Feb 2013
- Last updated
- 22 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D3 (Vit D3) Supplementation and T Cell Immunomodulation in Patients With Newly Diagnosed Operative Invasive Ductal Breast Carcinoma Stage I-II
- ClinicalTrials.gov ID
- NCT01816555
- Acronym / sponsor ID
- 101813
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed due to low accrual.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 22 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is for adult females who have been newly diagnosed with breast cancer that includes surgery as part of standard cancer treatment. This is a research study combining Vitamin D (an over the counter medication) with the standard of care (or the established and approved treatment), surgery. Evidence shows that women who are Vitamin D3 deficient have a higher risk of breast cancer and breast cancer recurrence. The purpose of this study is to find out the effects of Vitamin D3 during the treatment period for Stage I-II breast cancer. Screening tests will be done to determine if subjects are eligible to participate in this study. If subjects are eligible and they agree to participate, they will be assigned to one of two groups which will receive different amounts of vitamin D. Subjects will be asked to keep a medication diary. Subjects may remain on treatment for approximately 56 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D- Normal Level at Screening | Experimental | Dietary Supplement: Vitamin DSubjects will have surgery as their initial breast therapy. If subjects have a normal level of Vitamin D(25-hydroxyVit D 30-100ng/mL), they will be assigned to this group. |
| Vitamin D- Insufficient or Deficient Level at Screening | Experimental | Dietary Supplement: Vitamin DSubjects will have surgery as their initial breast therapy. If subjects are insufficient (25-hydroxy Vit D 21-29 ng/mL)or deficient (25-hydroxyVit D <20ng/mL) Vitamin D levels, they will be assigned to this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must be greater than or equal to 18 years of age.
- Patients must have a newly diagnosed invasive ductal breast carcinoma, Stage I-II.
- Patients who have completed their surgical and radiation therapy.
- Patients must have SWOG performance status of 0, 1 or 2.
- Patients must have adequate organ function as defined by:
Key exclusion criteria (21 listed)
- Patients with histology of lobular carcinoma.
- Patients with metastatic disease.
- Pregnant or lactating women.
- Male gender.
- Patients with a history of sarcoidosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DSubjects will be assigned to a dosage level between 600IU daily and 10,000IU daily depending on their age, weight and current vitamin D level | Dietary supplement | Vitamin D- Insufficient or Deficient Level at Screening, Vitamin D- Normal Level at Screening |
Primary outcome
Compare the differences in the T cell phenotype and function using PBMCs from patients in different cohorts
Time frame: Prior to Treatment (Baseline), Week 4 and Week 8
T cell analysis for the following markers will be evaluated- 1. memory markers 2. activation status and presence of regulatory T cells 3. lymphoid organ-homing receptors 4. Functional status of gated T cells will be analyzed 5. cell surface thiol molecules and intracellular glutathione using flow cytometry to evaluate if anti-oxidant stus of the T cells is modulated in presence of the Vitamin D. These markers will help in determining the immunomodulatory potential of Vitamin D on T cell with respect to function, activation status and anti-oxidant capacity that can effect persistence and in turn immune outcome. The data obtained will be reported in terms of percent increase or decrease in number of T cells expressing particular receptors (homing or chemokine) or for differences in functional outcome (cytokine response) upon activation relative to samples collected at baseline.
Results and safety
The study was stopped early (reason given: Study closed due to low accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vitamin D in people with Newly Diagnosed Operative Invasive Ductal Breast Carcinoma Stage I-II, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study closed due to low accrual.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the differences in the T cell phenotype and function using PBMCs from patients in different cohorts (time frame: Prior to Treatment (Baseline), Week 4 and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2015.