Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
An open clinical trial not randomized, multicentric. This study search to evaluate vitamin D supplementation efficacy at high dose (UVEDOSE, colecalciferol, oral solution at 100 000 UI) of vitamin D on day 1 of each cycles for breast cancer treated adjuvant chemotherapy.
A calcium supplementation will be prescribed in parallel.
An initial dosage of 25OH vitamin D rate will be done and a vitamin-calcic dosage will done on day 1 of every cycles of chemotherapy
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VITAMIN D SUPPLEMENTATION ARM | Experimental | On day 1 of every chemotherapy cycle, the patient will be receive an oral solution of vitamin D (UVEDOSE/calciferol). In parallel,a calcium supplementation is prescribed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VITAMIN D | Dietary Supplement | ORAL SOLUTION (2 ml) at 100.000 UI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Normalisation of Vitamin D level | percentage of vitamin D level normalisation | from the Cycle 1 to cycle 6 (each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| initial vitamin D and calcium level | blood test | at cycle 1( one cycle is 21 days) |
| normalization of 25-OHD (vitamin D) | blood test | at FU 6,12,18,24 months after the first dose of vitamin D |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| WILLIAM JACOT, MD | Institut régional du cancer de Montpellier | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | Montpellier | 34298 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19099529 | Result | Cavalier E, Delanaye P, Chapelle JP, Souberbielle JC. Vitamin D: current status and perspectives. Clin Chem Lab Med. 2009;47(2):120-7. doi: 10.1515/CCLM.2009.036. | |
| 19116321 | Result | Sinotte M, Diorio C, Berube S, Pollak M, Brisson J. Genetic polymorphisms of the vitamin D binding protein and plasma concentrations of 25-hydroxyvitamin D in premenopausal women. Am J Clin Nutr. 2009 Feb;89(2):634-40. doi: 10.3945/ajcn.2008.26445. Epub 2008 Dec 30. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
A phase 2 clinical trial not randomized
Not provided
Not provided
Not provided
Not provided
| adverses events rates | graded based on NCI-CTCAE v4.03 | from cycle 1 to follow-up 24 months (one cycle is 21 days) |
| vitamin D and calcium level | blood test | from cycle 1 to 24 months (one cycle is 21 days) |
| 17634462 | Result | Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available. |
| 15886381 | Result | Bischoff-Ferrari HA, Willett WC, Wong JB, Giovannucci E, Dietrich T, Dawson-Hughes B. Fracture prevention with vitamin D supplementation: a meta-analysis of randomized controlled trials. JAMA. 2005 May 11;293(18):2257-64. doi: 10.1001/jama.293.18.2257. |
| 17720017 | Result | Tang BM, Eslick GD, Nowson C, Smith C, Bensoussan A. Use of calcium or calcium in combination with vitamin D supplementation to prevent fractures and bone loss in people aged 50 years and older: a meta-analysis. Lancet. 2007 Aug 25;370(9588):657-66. doi: 10.1016/S0140-6736(07)61342-7. |
| 18387220 | Result | Roux C, Bischoff-Ferrari HA, Papapoulos SE, de Papp AE, West JA, Bouillon R. New insights into the role of vitamin D and calcium in osteoporosis management: an expert roundtable discussion. Curr Med Res Opin. 2008 May;24(5):1363-70. doi: 10.1185/030079908x301857. Epub 2008 Apr 2. |
| 15113819 | Result | Bischoff-Ferrari HA, Dawson-Hughes B, Willett WC, Staehelin HB, Bazemore MG, Zee RY, Wong JB. Effect of Vitamin D on falls: a meta-analysis. JAMA. 2004 Apr 28;291(16):1999-2006. doi: 10.1001/jama.291.16.1999. |
| 18419802 | Result | Abbas S, Nieters A, Linseisen J, Slanger T, Kropp S, Mutschelknauss EJ, Flesch-Janys D, Chang-Claude J. Vitamin D receptor gene polymorphisms and haplotypes and postmenopausal breast cancer risk. Breast Cancer Res. 2008;10(2):R31. doi: 10.1186/bcr1994. Epub 2008 Apr 17. |
| 17974532 | Result | Abbas S, Linseisen J, Slanger T, Kropp S, Mutschelknauss EJ, Flesch-Janys D, Chang-Claude J. Serum 25-hydroxyvitamin D and risk of post-menopausal breast cancer--results of a large case-control study. Carcinogenesis. 2008 Jan;29(1):93-9. doi: 10.1093/carcin/bgm240. Epub 2007 Oct 31. |
| 19655244 | Result | Khan QJ, Reddy PS, Kimler BF, Sharma P, Baxa SE, O'Dea AP, Klemp JR, Fabian CJ. Effect of vitamin D supplementation on serum 25-hydroxy vitamin D levels, joint pain, and fatigue in women starting adjuvant letrozole treatment for breast cancer. Breast Cancer Res Treat. 2010 Jan;119(1):111-8. doi: 10.1007/s10549-009-0495-x. Epub 2009 Aug 5. |
| 21384167 | Result | Peppone LJ, Huston AJ, Reid ME, Rosier RN, Zakharia Y, Trump DL, Mustian KM, Janelsins MC, Purnell JQ, Morrow GR. The effect of various vitamin D supplementation regimens in breast cancer patients. Breast Cancer Res Treat. 2011 May;127(1):171-7. doi: 10.1007/s10549-011-1415-4. Epub 2011 Mar 8. |
| 19546403 | Result | Mann GB, Kang YC, Brand C, Ebeling PR, Miller JA. Secondary causes of low bone mass in patients with breast cancer: a need for greater vigilance. J Clin Oncol. 2009 Aug 1;27(22):3605-10. doi: 10.1200/JCO.2008.20.2549. Epub 2009 Jun 22. |
| 34959982 | Derived | Chartron E, Firmin N, Touraine C, Chapelle A, Legouffe E, Rifai L, Pouderoux S, Roca L, D'Hondt V, Jacot W. A Phase II Multicenter Trial on High-Dose Vitamin D Supplementation for the Correction of Vitamin D Insufficiency in Patients with Breast Cancer Receiving Adjuvant Chemotherapy. Nutrients. 2021 Dec 10;13(12):4429. doi: 10.3390/nu13124429. |
| D017437 |
| Skin and Connective Tissue Diseases |