Influence of Preoperative Vitamin D Level on Postoperative Pain in Breast Cancer Surgery Patients

NCT06551688 | Completed

• 1 other identifier: D328
• Study Type: observational
• Target: 184
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Cancer Breast; Hypovitaminosis D

Keywords

preoperative vitamin D level; postoperative pain; cancer breast surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of moderate to severe postoperative pain

  Incidence

  at 12 hours after surgery

Secondary Outcomes (13)

• American Society of Anaesthesiologists

  24 hours before operation

• Pain assessment by NRS

  24 hours before operation during the preoperative visit

• Previous associated comorbidities

  24 hours before operation

• Preoperative Serum 25(OH)D level (nmol/L)

  24 hours before operation

• Duration of surgery

  from start to the end of operation

Study Arms (2)

group D

vitamin D-deficient group (\<30nmol/L)

Diagnostic Test: Serum 25(OH)D level

group S

vitamin D-sufficient group (≥30nmol/L)

Diagnostic Test: Serum 25(OH)D level

Interventions

Serum 25(OH)D level DIAGNOSTIC_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

group D; group S

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Female patients ASA II -III.
• aged 20-65 years, who will be scheduled to undergo elective unilateral breast cancer surgery.
• modified radical mastectomy.

You may not qualify if:

• 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.
• severe liver and kidney diseases.
• severe peripheral or central neuropathy.
• heart failure.
• pneumonia.
• parenteral nutrition patients.

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Fayoum university hospital

El Fayoum Qesm, Faiyum Governorate, 63514, Egypt

Location

Related Publications (15)

• 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.

  PMID: 36258760 BACKGROUND

• Roth 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.

  PMID: 30225965 BACKGROUND

• Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.

  PMID: 17634462 BACKGROUND

• Imtiaz 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.

  PMID: 22629509 BACKGROUND

• Bose 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.

  PMID: 25752462 BACKGROUND

• Ulitsky 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.

  PMID: 21527593 BACKGROUND

• Martinez-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.

  PMID: 26315460 BACKGROUND

• Sharma 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.

  PMID: 22247839 BACKGROUND

• Welsh 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.

  PMID: 28746837 BACKGROUND

• Feldman 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.

  PMID: 24705652 BACKGROUND

• Deeb 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.

  PMID: 17721433 BACKGROUND

• Altieri 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.

  PMID: 27030935 BACKGROUND

• Meeker 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.

  PMID: 26811638 BACKGROUND

• Jacobs 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.

  PMID: 26918035 BACKGROUND

• Xia 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.

  PMID: 36288586 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Vitamin D Deficiency; Pain, Postoperative

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Mohamed A Hamed, A.professor

  Faculty of medicine , Fayoum university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of anaesthesiology

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: August 13, 2024
• Study Start: September 1, 2024
• Primary Completion: April 20, 2025
• Study Completion: April 20, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-05

Locations

EG (1)