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Vitamin D Replacement Therapy Can Affects Pathological Response in Neoadjuvant Breast Cancer Treatment

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ClinicalTrials.gov Identifier: NCT03986268
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Cetin Ordu, Florence Nightingale Hospital, Istanbul

Brief Summary:
The aim of the study is to evaluate the relationship between the vitamin D replacement and pathological response in patients undergoing neoadjuvant therapy according to different molecular sub types. Because of no study evaluating pathological response to neoadjuvant therapy with vitamin D replacement in patients with breast cancer.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Chemotherapy Effect Pathology Drug: Vit D Not Applicable

Detailed Description:
Calcitriol, a vitamin D metabolite, inhibits cell proliferation and pathways in invitro experiments. Vitamin D affects gene expression related to breast cancer and prevents cell differentiation, growth and angiogenesis . Low vitamin D may include a high risk of breast cancer, but there are also studies reporting that patients with low vitamin D levels at the time of diagnosis show more aggressive breast cancer course . Breast cells can produce vitamin D by taking part in the formation of 1,25 OH vit D3 in vitamin D synthesis as well as in kidney cells. Apoptosis can be caused by vitamin D receptors . There are very few studies on the effect of vitamin D replacement on breast cancer-related survival. There are studies reporting the incidence of fewer breast cancer with vitamin D replacement in contrast to there are studies showing the opposite .Patients achieved pathological complete response (PCR) with neoadjuvant therapy have been shown to have better survival. There are studies showing that they do not affect the PCR ratio related to the level of vitamin D in breast cancer patients receiving neoadjuvant chemotherapy. In one study, it was shown that it increases the response rate when given with bisphosphonate .There is no study evaluating pathological response to neoadjuvant therapy with vitamin D replacement in patients with breast cancer. The aim of the study is to evaluate the relationship between the vitamin D replacement and pathological response in patients undergoing neo-adjuvant therapy according to different molecular subtypes of biopsy-diagnosed breast cancer patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: The patients had measured a total of 25 OH vit D3 levels, previously treated with neoadjuvant therapy without replacement treatment with vitamine D3, as a control group, were planned to be compared with 30-50 patient in study groups at baseline and / or at the end of the treatment period. The pathological response rates of both groups were planned to be evaluated according to the molecular subtypes.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Vitamin D Replacement Therapy on Pathological Response in Breast Cancer Treatment With Neoadjuvant Therapy
Actual Study Start Date : May 10, 2019
Estimated Primary Completion Date : May 10, 2020
Estimated Study Completion Date : May 10, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: study group
The patients measured a total of 25 OH vitamin D3 levels, initial, 3'th month and 6'th month of neoadjuvant therapy with replacement treatment with vitamin D3 at least weekly 50000 IU for eight weeks.
Drug: Vit D
The aim of this study is investigating pathologic response to neoadjuvant therapy if we give replacement therapy with vitamin D3 50.000 IU weekly dosage concurrent with chemotherapy in breast cancer patients.
Other Names:
  • Vitamin D3
  • cholecalciferol

control group
The patients had measured a total of 25 OH vitamin D3 levels, previously treated with neoadjuvant therapy without replacement treatment with vitamin D3.
Drug: Vit D
The aim of this study is investigating pathologic response to neoadjuvant therapy if we give replacement therapy with vitamin D3 50.000 IU weekly dosage concurrent with chemotherapy in breast cancer patients.
Other Names:
  • Vitamin D3
  • cholecalciferol




Primary Outcome Measures :
  1. pathological complete response (PCR) [ Time Frame: an average 24 weeks ]
    No residual tumor cells both in axilla and breast


Secondary Outcome Measures :
  1. pathological complete response (PCR) relations with vitamin D levels [ Time Frame: an average 24 weeks ]
    evaluating PCR in both axilla and breast in terms of levels of total 25 (OH) vitamin D at initial and after replacement vitamin D

  2. pathological complete response (PCR) ratio regarding molecular sub types [ Time Frame: an average 24 weeks ]
    evaluating PCR in both axilla and breast in terms of levels of total 25 (OH) vitamin D at initial and after replacement vitamin D according moleculary subtypes



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Invasive breast cancer is confirmed by biopsy
  • enough organ function,
  • metabolically normal,
  • eligible for neoadjuvant treatment
  • The patients who were informed about the prerequisites with their consent

Exclusion Criteria:

  • having metastatic disease
  • having not operated from breast cancer after neoadjuvant treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986268


Contacts
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Contact: Çetin Ordu, Assoc.Prof +902122883400 cetinordu@hotmail.com
Contact: Fatma Aktepe, Prof +902122883400 fatma.aktepe@florence.com.tr

Locations
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Turkey
İstanbul Florence Nightingale Hospital Breast Health Center Recruiting
Istanbul, Şişli, Turkey, 34450
Contact: Çetin Ordu, Assoc.Prof    +902122883400    cetinordu@hotmail.com   
Contact: Fatma Aktepe, Prof    +902122883400    fatma.aktepe@florence.com.tr   
Sponsors and Collaborators
Florence Nightingale Hospital, Istanbul
Investigators
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Principal Investigator: Çetin Ordu, Assoc. Prof Gayrettepe FN Hospital
Study Director: Fatma Aktepe, Prof Gayrettepe FN Hospital
Study Chair: Vahit Özmen, Prof İstanbul FN hospital

Publications of Results:

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Responsible Party: Cetin Ordu, Assoc. Prof. Çetin Ordu, MD, Florence Nightingale Hospital, Istanbul
ClinicalTrials.gov Identifier: NCT03986268     History of Changes
Other Study ID Numbers: 2019-40016-06
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The aim of the study was to evaluate the relationship between the vitamin D replacement and pathological response in patients undergoing biopsy-diagnosed neo-adjuvant therapy according to different molecular subtypes.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Cetin Ordu, Florence Nightingale Hospital, Istanbul:
neoadjuvant treatment
Breast Cancer
Vitamin D3

Additional relevant MeSH terms:
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Breast Neoplasms
Vitamin D Deficiency
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents