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Colon CancerNCT02603757

Effectiveness of High Dose Vitamin D Supplementation in Stage III Colorectal Cancer

A study testing cholecalciferol in people with Colon Cancer and Rectal Cancer, run by Legacy Health System at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a pilot study to test whether there is an association between baseline Vitamin D levels, Vitamin D supplementation and survival in patients with stage III colon and stage II/III rectal cancer receiving chemotherapy. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Colon Cancer, Rectal Cancer
What is being tested?
cholecalciferol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
3 sitesUnited States
Study dates
Mar 2016to Jun 2020
Phase
Interventional
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 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 18 years of age
  • Willing to stop herbal medications as directed by physician
  • Willing to stop current supplemental Vitamin D (Multivitamin with Vitamin D component is acceptable)
  • Willing to travel to Legacy Health/OHSU facility if necessary
  • Agree to attend study visits outside of standard of care visits, if necessary
  • Diagnosed with stage III colon or stage II/III rectal cancer that will receive neoadjuvant or adjuvant chemotherapy but have not yet started
  • Baseline serum Vitamin D level below 52 ng/ml

Who cannot join

  • ≤ 18 years of age
  • Colon cancer stages I-II and IV or Rectal cancer stage I or IV
  • Patients who do not undergo chemotherapy
  • Patients with prior chemotherapy for this cancer
  • No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cancer, or other cancer for which the patient has been disease-free for > 3 years
  • Unable to comply with protocol
Show all 12Show fewer
  • Unable to provide written informed consent
  • Unwilling or unable to stop oral supplemental Vitamin D
  • Patients taking high-dose Vitamin D supplementation (50,000 IU weekly) prior to enrollment
  • Patients with Vitamin D levels above 52 ng/ml at baseline testing
  • Patients with hypercalcemia and/or any condition resulting in malabsorption
  • Investigator does not believe study participation, for any reason, is in the best interest of the patient

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

  • Legacy Good Samaritan Medical Center

    Portland, Oregon, 97210

  • Legacy Meridian Park Medical Center

    Tualatin, Oregon, 97062

Other trials in United States

About this study

Official title: Prospective Pilot Study to Assess the Effectiveness of Vitamin D Supplementation for Patients Requiring Chemotherapy for Stage III Colorectal Cancer

This is a pilot study to test whether there is an association between baseline Vitamin D levels, Vitamin D supplementation and survival in patients with stage III colon and stage II/III rectal cancer receiving chemotherapy. 70 patients with colon stage III or rectal stage II or III cancer that require chemotherapy will be screened and 60 patients will be enrolled. Patients will be randomized to standard dose (2000 IU daily) or high-dose (50,000 IU weekly) Vitamin D supplementation for 1 year after initiation of chemotherapy. Patients' Vitamin D levels will be checked throughout supplementation then followed for 5 years with occasional Vitamin D testing and surveying in order to collect information on recurrence and survival outcomes.

Being tested
cholecalciferol
Keywords
Vitamin D
Medical subject headings
Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cholecalciferolDietary supplement

    Also called Vitamin D3

    2,000 IU of Vitamin D3 daily and 50,000 IU Vitamin D3 daily

Study groups in NCT02603757
Study groupRoleWhat they receive
Group AActive comparatorStandard-dose of 2,000 IU Vitamin D3, daily
Receives: Dietary Supplement: cholecalciferol
Group BExperimentalHigher-dose of 50,000 IU of Vitamin D3, weekly
Receives: Dietary Supplement: cholecalciferol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Increase in serum Vitamin D3 level during chemotherapy in the active supplementation group compared to the control group.

    Measured: 1 year

Secondary outcomes (2)

  1. Relapse-free survival (RFS)

    Measured: 5 years

  2. Overall survival (OS)

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2015 (estimated)
  2. Study startMar 2016
  3. Primary completionJun 2020
  4. Study completionJun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02603757
Sponsor's protocol ID
Vitamin D & Colorectal Cancer
Status last verified
Sep 2020
First submitted
9 Nov 2015
Last updated
1 Oct 2020
Results posted
No
Data monitoring committee
No

Publications

  • Fiscella K, Winters P, Tancredi D, Hendren S, Franks P. Racial disparity in death from colorectal cancer: does vitamin D deficiency contribute? Cancer. 2011 Mar 1;117(5):1061-9. doi: 10.1002/cncr.25647. Epub 2010 Oct 13.

    PubMed 20945439

  • Zgaga L, Theodoratou E, Farrington SM, Din FV, Ooi LY, Glodzik D, Johnston S, Tenesa A, Campbell H, Dunlop MG. Plasma vitamin D concentration influences survival outcome after a diagnosis of colorectal cancer. J Clin Oncol. 2014 Aug 10;32(23):2430-9. doi: 10.1200/JCO.2013.54.5947. Epub 2014 Jul 7.

    PubMed 25002714

  • Ng K, Sargent DJ, Goldberg RM, Meyerhardt JA, Green EM, Pitot HC, Hollis BW, Pollak MN, Fuchs CS. Vitamin D status in patients with stage IV colorectal cancer: findings from Intergroup trial N9741. J Clin Oncol. 2011 Apr 20;29(12):1599-606. doi: 10.1200/JCO.2010.31.7255. Epub 2011 Mar 21.

    PubMed 21422438

  • Brunner RL, Wactawski-Wende J, Caan BJ, Cochrane BB, Chlebowski RT, Gass ML, Jacobs ET, LaCroix AZ, Lane D, Larson J, Margolis KL, Millen AE, Sarto GE, Vitolins MZ, Wallace RB. The effect of calcium plus vitamin D on risk for invasive cancer: results of the Women's Health Initiative (WHI) calcium plus vitamin D randomized clinical trial. Nutr Cancer. 2011;63(6):827-41. doi: 10.1080/01635581.2011.594208. Epub 2011 Jul 20.

    PubMed 21774589

  • Fakih MG, Andrews C, McMahon J, Muindi JR. A prospective clinical trial of cholecalciferol 2000 IU/day in colorectal cancer patients: evidence of a chemotherapy-response interaction. Anticancer Res. 2012 Apr;32(4):1333-8.

    PubMed 22493367

  • Fedirko V, Bostick RM, Flanders WD, Long Q, Shaukat A, Rutherford RE, Daniel CR, Cohen V, Dash C. Effects of vitamin D and calcium supplementation on markers of apoptosis in normal colon mucosa: a randomized, double-blind, placebo-controlled clinical trial. Cancer Prev Res (Phila). 2009 Mar;2(3):213-23. doi: 10.1158/1940-6207.CAPR-08-0157. Epub 2009 Mar 3.

    PubMed 19258546

  • Fernandez-Garcia NI, Palmer HG, Garcia M, Gonzalez-Martin A, del Rio M, Barettino D, Volpert O, Munoz A, Jimenez B. 1alpha,25-Dihydroxyvitamin D3 regulates the expression of Id1 and Id2 genes and the angiogenic phenotype of human colon carcinoma cells. Oncogene. 2005 Sep 29;24(43):6533-44. doi: 10.1038/sj.onc.1208801.

    PubMed 16007183

  • Fedirko V, Bostick RM, Long Q, Flanders WD, McCullough ML, Sidelnikov E, Daniel CR, Rutherford RE, Shaukat A. Effects of supplemental vitamin D and calcium on oxidative DNA damage marker in normal colorectal mucosa: a randomized clinical trial. Cancer Epidemiol Biomarkers Prev. 2010 Jan;19(1):280-91. doi: 10.1158/1055-9965.EPI-09-0448.

    PubMed 20056649

  • Bee CR, Sheerin DV, Wuest TK, Fitzpatrick DC. Serum vitamin D levels in orthopaedic trauma patients living in the northwestern United States. J Orthop Trauma. 2013 May;27(5):e103-6. doi: 10.1097/BOT.0b013e31825cf8fb.

    PubMed 22576645

  • Morgan SL, Weinsier RL. Fundamentals of clinical nutrition, Mosby, St. Louis 1998. p.3

Questions about this trial

What is this clinical trial studying?

A study testing cholecalciferol in people with Colon Cancer and Rectal Cancer, run by Legacy Health System at 3 sites in United States.

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 7 inclusion and 12 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 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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?

Increase in serum Vitamin D3 level during chemotherapy in the active supplementation group compared to the control group. (time frame: 1 year). 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 NCT02603757, which also lists 10 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 1 Oct 2020.

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