Cancer BreastNCT06551688
Influence of Preoperative Vitamin D Level on Postoperative Pain in Breast Cancer Surgery Patients
An observational study of Cancer Breast and Hypovitaminosis D, run by Fayoum University at 1 site in Egypt.
Trial summary
Vitamin D deficiency is a general problem that vigorously affects human health . Breast cancer is the most frequently diagnosed life-threatening cancer in women and the leading cause of cancer death among women.Vitamin D deficiency is common in breast cancer patients and some evidence suggests that low vitamin D… Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Cancer Breast, Hypovitaminosis D
- What is being tested?
- Serum 25(OH)D level
- How many people
- 184 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 20 Apr 2025
- Phase
- Observational
- 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 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: newly diagnosed and pathologically proven breast cancer patients who are prepared for elective breast cancer surgery will be recruited from the general surgery department of Fayoum university hospital.
Who may be able to join
- Female patients ASA II -III.
- aged 20-65 years, who will be scheduled to undergo elective unilateral breast cancer surgery.
- modified radical mastectomy.
Who cannot join
- Patient refusal.
- Chronic opioid use.
- cognitive disorders.
- patients using drugs affecting the levels of calcium, phosphorus, and vitamin D, such as vitamin D supplement, calcitonin, and estrogen or its analogs, one month before enrolment.
- hyperparathyroidism or undergoing parathyroidectomy.
- diseases affecting vitamin D absorption, such as long-term diarrhea, chronic pancreatitis, biliary obstruction, colitis, partial resection of the small intestine.
Show all 11Show fewer
- severe liver and kidney diseases.
- severe peripheral or central neuropathy.
- heart failure.
- pneumonia.
- parenteral nutrition patients.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Fayoum university hospital
El Fayoum Qesm, Faiyum Governorate, 63514
About this study
Official title: Influence of Preoperative Vitamin D Level on Postoperative Pain in Breast Cancer Surgery Patients: A Prospective Observational Study
Vitamin D deficiency is a general problem that vigorously affects human health . Breast cancer is the most frequently diagnosed life-threatening cancer in women and the leading cause of cancer death among women.Vitamin D deficiency is common in breast cancer patients and some evidence suggests that low vitamin D status enhances the risk for disease development or progression .
Though the relationship between vitamin D and breast cancer is unclear . Several research studies currently support vitamin D deficiency as a risk factor for breast cancer. Observational studies have also revealed significant relationships of vitamin D with breast cancer, colorectal cancer, prostate cancer and pancreatic cancer .
Read more
However, no work has been done to investigate the relationship between vitamin D deficiency and acute postoperative pain in breast cancer surgery patients. In the current study we will investigate the relationship between preoperative vitamin D levels and acute postoperative pain in cancer breast surgery patients.
The aim of current study is to investigate the relationship between preoperative vitamin D levels and acute postoperative pain in breast cancer surgery patients.
Read the detailed description
This study will be performed in the FAYOUM University Hospital after the local Institutional Ethics Committee and local institutional review board approval. Newly diagnosed and pathologically proven breast cancer patients who are prepared for elective breast cancer surgery will be recruited from the general surgery department of our hospital. The study design will be prospective observational study. A detailed informed consent will be signed by the eligible patients before recruitment.
Measurement of vitamin D:
The characteristics of 25 (OH) D3 are relatively longer half-life than 1.25 (OH)2 D3, stability, strong detection repeatability, and no biological activity. Generally, systemic levels of the more stable 25 (OH) D3 are considered to be the best index to reflect status of vitamin D in the individual patient .
study design:
Serum 25(OH)D levels will be measured preoperative . Patients will be divided into two groups :
(1) group D: vitamin D-deficient group (<30nmol/L); and (2) group S: vitamin D-sufficient group (≥30nmol/L) .
Randomization:
Preoperative serum 25(OH) D levels will be assessed by an anaesthesiologist who will not be included in the study, to get the number of patients required in each group. Randomization will be done via computer-generated random numbers that will be placed in separate closed envelopes and will be opened by study investigators just after induction of general anaesthesia. Neither the patients, the study investigators, the attending clinicians nor the data collectors will be aware of the allocation of groups till the study ends. The patients will be allocated in 1:1 ratio to one of the two groups: group D: vitamin D-deficient group (n= 92 ), and group S: vitamin D-sufficient group (n= 92).
Anaesthesia procedure:
All patients will undergo routine preoperative investigations; CBC, coagulation profile, liver function tests, kidney function tests, ECG and preoperative serum 25(OH)D level. Upon arrival to the operating room, standard monitors (5-lead electrocardiogram, pulse oximeter, noninvasive blood pressure monitoring) will be applied and continue all over the operation. An IV access will be established. All patients will receive IV ondansetron 4 mg before induction of anesthesia as a premedication. General anesthesia will be performed as follows: induction using IV propofol (2mg/kg), atracurium (0.5mg/kg), and fentanyl (1 microgram/kg). A cuffed endotracheal tube (7mm ID) will be placed to secure the airway. Mechanical ventilation parameters will be adjusted to ensure proper oxygenation and ventilation with normocapnia. Maintenance of anesthesia will be made using inhalational anesthesia with isoflurane 1.5% volume concentration and IV atracurium (0.1 mg/kg) every 20 minutes. Continuous hemodynamic monitoring of blood pressure and heart rate will be done . If the systolic blood pressure decreased to a 20% below the baseline or less than 90 mmHg, 5 mg of ephedrine will be injected IV. Moreover, if the heart rate reduced to a 50 bpm or less, 0.5 mg of atropine will be injected IV. At the end of operation , the patients will be transferred to the postoperative anaesthesia care unit for routine monitoring and then to the general surgery department when they have a modified Aldrete score ≥9.
Postoperative Pain Management:
Throughout the first 24 hrs, patients will receive IV paracetamol 1 g every 8 hrs for postoperative analgesia according to the general surgery department protocol.
They also will receive IV tramadol through a patient controlled analgesia (PCA) system (concentration of 4 mg/mL); with; a 20 mg dose, a 10 mins lockout interval and a 50 mg 1 hr limit as supplementary analgesia with no background analgesia.
- Conditions
- Cancer Breast, Hypovitaminosis D
- Being tested
- Serum 25(OH)D level
- Keywords
- preoperative vitamin D level, postoperative pain, cancer breast surgery
- Medical subject headings
- Breast Neoplasms, Vitamin D Deficiency, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum 25(OH)D levelDiagnostic test
The characteristics of 25 (OH) D3 are relatively longer half-life than 1.25 (OH)2 D3, stability, strong detection repeatability, and no biological activity. Generally, systemic levels of the more stable 25 (OH) D3 are considered to be the best index to reflect status of vitamin D in the individual patient
| Study group | Role | What they receive |
|---|---|---|
| group D | vitamin D-deficient group (<30nmol/L) Receives: Diagnostic Test: Serum 25(OH)D level | |
| group S | vitamin D-sufficient group (≥30nmol/L) Receives: Diagnostic Test: Serum 25(OH)D level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of moderate to severe postoperative pain
Incidence
Measured: at 12 hours after surgery
Secondary outcomes (13)
American Society of Anaesthesiologists
The ASA Classification is a physical status classification used to determine a patient's risk with anaesthesia1. The classification runs from ASA I to ASA VI, with the higher the number indicating a greater risk
Measured: 24 hours before operation
Pain assessment by NRS
Pain assessment by numerical rating score (NRS) from 0 to 10 where 0 equals no pain and 10 equals the worst pain
Measured: 24 hours before operation during the preoperative visit
Previous associated comorbidities
like hypertension, diabetes mellitus, coronary artery disease, chronic renal failure and liver impairment
Measured: 24 hours before operation
Preoperative Serum 25(OH)D level (nmol/L)
Level
Measured: 24 hours before operation
Duration of surgery
Duration
Measured: from start to the end of operation
Total fentanyl consumption (in micrograms)
Pain
Measured: intraoperative till end of the operation
Heart rate
measured in beats per minute
Measured: baseline, every 30 minutes up to end of the operation
Non- invasive mean arterial blood pressure
measured in mmHg
Measured: baseline, every 30 minutes up to end of the operation
Postoperative pain scores
NRS (Numerical rating scale) (from 0 to 10) ,0 equals no pain and 10 equals the worst pain
Measured: at times: hour zero, hour 6, hour12, hour18, hour24 postoperative.
Total tramadol consumption
measured in mg
Measured: within 1st 24 hours postoperative
Incidence of adverse effects
nausea and vomiting (0 = no symptoms, 1 = only nausea, 2 = nausea and vomiting), respiratory depression (respiratory rate less than 10), sedation (0 = awake and alert,
1 = quietly awake, 2 = asleep but easily arousable, 3 = deep sleep, responding to painful stimulus)
Measured: during 1st 24 hours postoperative
Hospital stay
in days (defined as the time elapsed from day 0; the operative day; to the time of discharge)
Measured: from the date of the operation to the date of discharge from hospital
Patient satisfaction
will be assessed on a 4-point scale (1: excellent, 2: good 3: fair, 4: poor).
Measured: up to 2 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start1 Sep 2024
- Primary completion20 Apr 2025
- Study completion20 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Cancer BreastStudies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Hamed, Fayoum University
- Investigators
- Mohamed A Hamed, A.professor, Principal investigator, Faculty of medicine , Fayoum university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551688
- Sponsor's protocol ID
- D328
- Status last verified
- May 2025
- First submitted
- 3 Jul 2024
- Last updated
- 6 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zeng X, Chen X, Li C, Shi H. Preoperative Vitamin D Level is Associated with Acute Pain After Video-Assisted Thoracoscopic Surgery: A Retrospective Cohort Study. J Pain Res. 2022 Oct 12;15:3189-3196. doi: 10.2147/JPR.S382407. eCollection 2022.
PubMed 36258760Roth DE, Abrams SA, Aloia J, Bergeron G, Bourassa MW, Brown KH, Calvo MS, Cashman KD, Combs G, De-Regil LM, Jefferds ME, Jones KS, Kapner H, Martineau AR, Neufeld LM, Schleicher RL, Thacher TD, Whiting SJ. Global prevalence and disease burden of vitamin D deficiency: a roadmap for action in low- and middle-income countries. Ann N Y Acad Sci. 2018 Oct;1430(1):44-79. doi: 10.1111/nyas.13968. Epub 2018 Sep 18.
PubMed 30225965Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
PubMed 17634462Imtiaz S, Siddiqui N, Raza SA, Loya A, Muhammad A. Vitamin D deficiency in newly diagnosed breast cancer patients. Indian J Endocrinol Metab. 2012 May;16(3):409-13. doi: 10.4103/2230-8210.95684.
PubMed 22629509Bose S, Khanna A, You J, Arora L, Qavi S, Turan A. Low serum vitamin D levels are not associated with increased postoperative pain and opioid requirements: a historical cohort study. Can J Anaesth. 2015 Jul;62(7):770-6. doi: 10.1007/s12630-015-0357-4. Epub 2015 Mar 10.
PubMed 25752462Ulitsky A, Ananthakrishnan AN, Naik A, Skaros S, Zadvornova Y, Binion DG, Issa M. Vitamin D deficiency in patients with inflammatory bowel disease: association with disease activity and quality of life. JPEN J Parenter Enteral Nutr. 2011 May;35(3):308-16. doi: 10.1177/0148607110381267.
PubMed 21527593Martinez-Alonso M, Dusso A, Ariza G, Nabal M. Vitamin D deficiency and its association with fatigue and quality of life in advanced cancer patients under palliative care: A cross-sectional study. Palliat Med. 2016 Jan;30(1):89-96. doi: 10.1177/0269216315601954. Epub 2015 Aug 27.
PubMed 26315460Sharma GN, Dave R, Sanadya J, Sharma P, Sharma KK. Various types and management of breast cancer: an overview. J Adv Pharm Technol Res. 2010 Apr;1(2):109-26.
PubMed 22247839Welsh J. Vitamin D and breast cancer: Past and present. J Steroid Biochem Mol Biol. 2018 Mar;177:15-20. doi: 10.1016/j.jsbmb.2017.07.025. Epub 2017 Jul 23.
PubMed 28746837Feldman D, Krishnan AV, Swami S, Giovannucci E, Feldman BJ. The role of vitamin D in reducing cancer risk and progression. Nat Rev Cancer. 2014 May;14(5):342-57. doi: 10.1038/nrc3691. Epub 2014 Apr 4.
PubMed 24705652Deeb KK, Trump DL, Johnson CS. Vitamin D signalling pathways in cancer: potential for anticancer therapeutics. Nat Rev Cancer. 2007 Sep;7(9):684-700. doi: 10.1038/nrc2196.
PubMed 17721433Altieri B, Grant WB, Della Casa S, Orio F, Pontecorvi A, Colao A, Sarno G, Muscogiuri G. Vitamin D and pancreas: The role of sunshine vitamin in the pathogenesis of diabetes mellitus and pancreatic cancer. Crit Rev Food Sci Nutr. 2017 Nov 2;57(16):3472-3488. doi: 10.1080/10408398.2015.1136922.
PubMed 27030935Meeker S, Seamons A, Maggio-Price L, Paik J. Protective links between vitamin D, inflammatory bowel disease and colon cancer. World J Gastroenterol. 2016 Jan 21;22(3):933-48. doi: 10.3748/wjg.v22.i3.933.
PubMed 26811638Jacobs ET, Kohler LN, Kunihiro AG, Jurutka PW. Vitamin D and Colorectal, Breast, and Prostate Cancers: A Review of the Epidemiological Evidence. J Cancer. 2016 Jan 5;7(3):232-40. doi: 10.7150/jca.13403. eCollection 2016.
PubMed 26918035Xia J, Li D, Yu G, Xu B, Gao X, Wang H, Ma Y, Li X, Xiong Y. Effects of Hypovitaminosis D on Preoperative Pain Threshold and Perioperative Opioid Use in Colorectal Cancer Surgery: A Cohort Study. Pain Physician. 2022 Oct;25(7):E1009-E1019.
PubMed 36288586
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Preoperative Vitamin D Level on Postoperative Pain in Breast Cancer Surgery Patients: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06551688
- Acronym / sponsor ID
- D328
- Conditions
- Cancer Breast, Hypovitaminosis D
- Keywords
- preoperative vitamin D level, postoperative pain, cancer breast surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 20 Apr 2025 (actual)
- Study completion
- 20 Apr 2025 (actual)
- First posted
- 13 Aug 2024 (actual)
- 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.
Vitamin D deficiency is a general problem that vigorously affects human health . Breast cancer is the most frequently diagnosed life-threatening cancer in women and the leading cause of cancer death among women.Vitamin D deficiency is common in breast cancer patients and some evidence suggests that low vitamin D status enhances the risk for disease development or progression .
Though the relationship between vitamin D and breast cancer is unclear . Several research studies currently support vitamin D deficiency as a risk factor for breast cancer. Observational studies have also revealed significant relationships of vitamin D with breast cancer, colorectal cancer, prostate cancer and pancreatic cancer .
However, no work has been done to investigate the relationship between vitamin D deficiency and acute postoperative pain in breast cancer surgery patients. In the current study we will investigate the relationship between preoperative vitamin D levels and acute postoperative pain in cancer breast surgery patients.
The aim of current study is to investigate the relationship between preoperative vitamin D levels and acute postoperative pain in breast cancer surgery patients.
Detailed description
This study will be performed in the FAYOUM University Hospital after the local Institutional Ethics Committee and local institutional review board approval. Newly diagnosed and pathologically proven breast cancer patients who are prepared for elective breast cancer surgery will be recruited from the general surgery department of our hospital. The study design will be prospective observational study. A detailed informed consent will be signed by the eligible patients before recruitment.
Measurement of vitamin D:
The characteristics of 25 (OH) D3 are relatively longer half-life than 1.25 (OH)2 D3, stability, strong detection repeatability, and no biological activity. Generally, systemic levels of the more stable 25 (OH) D3 are considered to be the best index to reflect status of vitamin D in the individual patient .
study design:
Serum 25(OH)D levels will be measured preoperative . Patients will be divided into two groups :
(1) group D: vitamin D-deficient group (<30nmol/L); and (2) group S: vitamin D-sufficient group (≥30nmol/L) .
Randomization:
Preoperative serum 25(OH) D levels will be assessed by an anaesthesiologist who will not be included in the study, to get the number of patients required in each group. Randomization will be done via computer-generated random numbers that will be placed in separate closed envelopes and will be opened by study investigators just after induction of general anaesthesia. Neither the patients, the study investigators, the attending clinicians nor the data collectors will be aware of the allocation of groups till the study ends. The patients will be allocated in 1:1 ratio to one of the two groups: group D: vitamin D-deficient group (n= 92 ), and group S: vitamin D-sufficient group (n= 92).
Anaesthesia procedure:
All patients will undergo routine preoperative investigations; CBC, coagulation profile, liver function tests, kidney function tests, ECG and preoperative serum 25(OH)D level. Upon arrival to the operating room, standard monitors (5-lead electrocardiogram, pulse oximeter, noninvasive blood pressure monitoring) will be applied and continue all over the operation. An IV access will be established. All patients will receive IV ondansetron 4 mg before induction of anesthesia as a premedication. General anesthesia will be performed as follows: induction using IV propofol (2mg/kg), atracurium (0.5mg/kg), and fentanyl (1 microgram/kg). A cuffed endotracheal tube (7mm ID) will be placed to secure the airway. Mechanical ventilation parameters will be adjusted to ensure proper oxygenation and ventilation with normocapnia. Maintenance of anesthesia will be made using inhalational anesthesia with isoflurane 1.5% volume concentration and IV atracurium (0.1 mg/kg) every 20 minutes. Continuous hemodynamic monitoring of blood pressure and heart rate will be done . If the systolic blood pressure decreased to a 20% below the baseline or less than 90 mmHg, 5 mg of ephedrine will be injected IV. Moreover, if the heart rate reduced to a 50 bpm or less, 0.5 mg of atropine will be injected IV. At the end of operation , the patients will be transferred to the postoperative anaesthesia care unit for routine monitoring and then to the general surgery department when they have a modified Aldrete score ≥9.
Postoperative Pain Management:
Throughout the first 24 hrs, patients will receive IV paracetamol 1 g every 8 hrs for postoperative analgesia according to the general surgery department protocol.
They also will receive IV tramadol through a patient controlled analgesia (PCA) system (concentration of 4 mg/mL); with; a 20 mg dose, a 10 mins lockout interval and a 50 mg 1 hr limit as supplementary analgesia with no background analgesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group D | – | Diagnostic Test: Serum 25(OH)D levelvitamin D-deficient group (<30nmol/L) |
| group S | – | Diagnostic Test: Serum 25(OH)D levelvitamin D-sufficient group (≥30nmol/L) |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- newly diagnosed and pathologically proven breast cancer patients who are prepared for elective breast cancer surgery will be recruited from the general surgery department of Fayoum university hospital.
Key inclusion criteria (3 listed)
- Female patients ASA II -III.
- aged 20-65 years, who will be scheduled to undergo elective unilateral breast cancer surgery.
- modified radical mastectomy.
Key exclusion criteria (11 listed)
- Patient refusal.
- Chronic opioid use.
- cognitive disorders.
- patients using drugs affecting the levels of calcium, phosphorus, and vitamin D, such as vitamin D supplement, calcitonin, and estrogen or its analogs, one month before enrolment.
- hyperparathyroidism or undergoing parathyroidectomy.
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 |
|---|---|---|
| Serum 25(OH)D levelThe characteristics of 25 (OH) D3 are relatively longer half-life than 1.25 (OH)2 D3, stability, strong detection repeatability, and no biological activity. Generally, systemic levels of the more stable 25 (OH) D3 are considered to be the best index to reflect status of vitamin D in the individual patient | Diagnostic test | group D, group S |
Primary outcome
Incidence of moderate to severe postoperative pain
Time frame: at 12 hours after surgery
Incidence
13 secondary outcomes
American Society of Anaesthesiologists
Time frame: 24 hours before operation
Pain assessment by NRS
Time frame: 24 hours before operation during the preoperative visit
Previous associated comorbidities
Time frame: 24 hours before operation
Preoperative Serum 25(OH)D level (nmol/L)
Time frame: 24 hours before operation
Duration of surgery
Time frame: from start to the end of operation
Total fentanyl consumption (in micrograms)
Time frame: intraoperative till end of the operation
Heart rate
Time frame: baseline, every 30 minutes up to end of the operation
Non- invasive mean arterial blood pressure
Time frame: baseline, every 30 minutes up to end of the operation
Postoperative pain scores
Time frame: at times: hour zero, hour 6, hour12, hour18, hour24 postoperative.
Total tramadol consumption
Time frame: within 1st 24 hours postoperative
Incidence of adverse effects
Time frame: during 1st 24 hours postoperative
Hospital stay
Time frame: from the date of the operation to the date of discharge from hospital
Patient satisfaction
Time frame: up to 2 days postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Background: PubMed 36258760Zeng X, Chen X, Li C, Shi H. Preoperative Vitamin D Level is Associated with Acute Pain After Video-Assisted Thoracoscopic Surgery: A Retrospective Cohort Study. J Pain Res. 2022 Oct 12;15:3189-3196. doi: 10.2147/JPR.S382407. eCollection 2022.
- Background: PubMed 30225965Roth DE, Abrams SA, Aloia J, Bergeron G, Bourassa MW, Brown KH, Calvo MS, Cashman KD, Combs G, De-Regil LM, Jefferds ME, Jones KS, Kapner H, Martineau AR, Neufeld LM, Schleicher RL, Thacher TD, Whiting SJ. Global prevalence and disease burden of vitamin D deficiency: a roadmap for action in low- and middle-income countries. Ann N Y Acad Sci. 2018 Oct;1430(1):44-79. doi: 10.1111/nyas.13968. Epub 2018 Sep 18.
- Background: PubMed 17634462Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
- Background: PubMed 22629509Imtiaz S, Siddiqui N, Raza SA, Loya A, Muhammad A. Vitamin D deficiency in newly diagnosed breast cancer patients. Indian J Endocrinol Metab. 2012 May;16(3):409-13. doi: 10.4103/2230-8210.95684.
- Background: PubMed 25752462Bose S, Khanna A, You J, Arora L, Qavi S, Turan A. Low serum vitamin D levels are not associated with increased postoperative pain and opioid requirements: a historical cohort study. Can J Anaesth. 2015 Jul;62(7):770-6. doi: 10.1007/s12630-015-0357-4. Epub 2015 Mar 10.
- Background: PubMed 21527593Ulitsky A, Ananthakrishnan AN, Naik A, Skaros S, Zadvornova Y, Binion DG, Issa M. Vitamin D deficiency in patients with inflammatory bowel disease: association with disease activity and quality of life. JPEN J Parenter Enteral Nutr. 2011 May;35(3):308-16. doi: 10.1177/0148607110381267.
- Background: PubMed 26315460Martinez-Alonso M, Dusso A, Ariza G, Nabal M. Vitamin D deficiency and its association with fatigue and quality of life in advanced cancer patients under palliative care: A cross-sectional study. Palliat Med. 2016 Jan;30(1):89-96. doi: 10.1177/0269216315601954. Epub 2015 Aug 27.
- Background: PubMed 22247839Sharma GN, Dave R, Sanadya J, Sharma P, Sharma KK. Various types and management of breast cancer: an overview. J Adv Pharm Technol Res. 2010 Apr;1(2):109-26.
- Background: PubMed 28746837Welsh J. Vitamin D and breast cancer: Past and present. J Steroid Biochem Mol Biol. 2018 Mar;177:15-20. doi: 10.1016/j.jsbmb.2017.07.025. Epub 2017 Jul 23.
- Background: PubMed 24705652Feldman D, Krishnan AV, Swami S, Giovannucci E, Feldman BJ. The role of vitamin D in reducing cancer risk and progression. Nat Rev Cancer. 2014 May;14(5):342-57. doi: 10.1038/nrc3691. Epub 2014 Apr 4.
- Background: PubMed 17721433Deeb KK, Trump DL, Johnson CS. Vitamin D signalling pathways in cancer: potential for anticancer therapeutics. Nat Rev Cancer. 2007 Sep;7(9):684-700. doi: 10.1038/nrc2196.
- Background: PubMed 27030935Altieri B, Grant WB, Della Casa S, Orio F, Pontecorvi A, Colao A, Sarno G, Muscogiuri G. Vitamin D and pancreas: The role of sunshine vitamin in the pathogenesis of diabetes mellitus and pancreatic cancer. Crit Rev Food Sci Nutr. 2017 Nov 2;57(16):3472-3488. doi: 10.1080/10408398.2015.1136922.
- Individual participant dataSharing planned: Undecided
Related trials for Cancer Breast
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Mohamed A Hamed, A.professor principal investigator
Faculty of medicine , Fayoum university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Breast and Hypovitaminosis D, run by Fayoum University at 1 site in Egypt.
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 3 inclusion and 11 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: finished, as of the sponsor's last update on 6 May 2025. 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 Egypt. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of moderate to severe postoperative pain (time frame: at 12 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06551688, which also lists 15 linked publications.
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 6 May 2025.