Vitamin D Supplementation to Correct the Vitamin D Deficiency for Breast Cancer

NCT04091178 | Completed Phase 2

• 1 other identifier: ICM2013/06
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Normalisation of Vitamin D level

  percentage of vitamin D level normalisation

  from the Cycle 1 to cycle 6 (each cycle is 21 days)

Secondary Outcomes (4)

• initial vitamin D and calcium level

  at cycle 1( one cycle is 21 days)

• normalization of 25-OHD (vitamin D)

  at FU 6,12,18,24 months after the first dose of vitamin D

• adverses events rates

  from cycle 1 to follow-up 24 months (one cycle is 21 days)

• vitamin D and calcium level

  from cycle 1 to 24 months (one cycle is 21 days)

Study Arms (1)

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.

Dietary Supplement: VITAMIN D

Interventions

VITAMIN D DIETARY_SUPPLEMENT

ORAL SOLUTION (2 ml) at 100.000 UI

VITAMIN D SUPPLEMENTATION ARM

Eligibility Criteria

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

You may qualify if:

• Breast adenocarcinoma should receive 6 cycles of adjuvant chemotherapy
• Women ≥ 18 years old (no age limit)
• Performance status :0 or 1
• Patients must be affiliated to a Social Security System
• Signed informed consent obtained before any study specific procedures.
• Vitamin D deficiency confirmed ( vitamin D result must be \< at 30 ng/ml)

You may not qualify if:

• Metastatic disease
• Patients with previous or concomitant other (not breast cancer) malignancy within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease free for at least five years
• calcium or colecalciferol contraindications (vitamin D hypersensitivity - disease or an other condition result in hypercalcaemia or hypercalciuria -Calcic lithiasis- high vitamin D level)
• Presence of the following diseases in the last 3 years : endocrinal disease, A phosphor calcic disorder treated by vitamin D supplementation at 1000 UI/day or more (this patient who have received a dose \< 1000 UI/day, will be included after have to stop Vitamin D at least 48 hours ) - Osteopenia or osteoporosis confirmed treated
• Concomittant treatment with an other experimental product
• Pregnant or breastfeeding women
• Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study.

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

Related Publications (13)

• 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.

  PMID: 19099529 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.

  PMID: 19116321 RESULT

• 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 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.

  PMID: 15886381 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.

  PMID: 17720017 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.

  PMID: 18387220 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.

  PMID: 15113819 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.

  PMID: 18419802 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.

  PMID: 17974532 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.

  PMID: 19655244 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.

  PMID: 21384167 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.

  PMID: 19546403 RESULT

• 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.

  PMID: 34959982 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• WILLIAM JACOT, MD

  Institut régional du cancer de Montpellier

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A phase 2 clinical trial not randomized

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 16, 2019
• Study Start: October 10, 2013
• Primary Completion: June 11, 2015
• Study Completion: March 16, 2017
• Last Updated: September 16, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)