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

Primary Purpose

Colon Cancer, Rectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cholecalciferol
Sponsored by
Legacy Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring Vitamin D

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ≥ 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

Exclusion Criteria:

  • ≤ 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
  • 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

Sites / Locations

  • Legacy Mount Hood Medical Center
  • Legacy Good Samaritan Medical Center
  • Legacy Meridian Park Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A

Group B

Arm Description

Standard-dose of 2,000 IU Vitamin D3, daily

Higher-dose of 50,000 IU of Vitamin D3, weekly

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Relapse-free survival (RFS)
Overall survival (OS)

Full Information

First Posted
November 9, 2015
Last Updated
September 29, 2020
Sponsor
Legacy Health System
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1. Study Identification

Unique Protocol Identification Number
NCT02603757
Brief Title
Effectiveness of High Dose Vitamin D Supplementation in Stage III Colorectal Cancer
Official Title
Prospective Pilot Study to Assess the Effectiveness of Vitamin D Supplementation for Patients Requiring Chemotherapy for Stage III Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Legacy Health System

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Rectal Cancer
Keywords
Vitamin D

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Standard-dose of 2,000 IU Vitamin D3, daily
Arm Title
Group B
Arm Type
Experimental
Arm Description
Higher-dose of 50,000 IU of Vitamin D3, weekly
Intervention Type
Dietary Supplement
Intervention Name(s)
cholecalciferol
Other Intervention Name(s)
Vitamin D3
Intervention Description
2,000 IU of Vitamin D3 daily and 50,000 IU Vitamin D3 daily
Primary Outcome Measure Information:
Title
Increase in serum Vitamin D3 level during chemotherapy in the active supplementation group compared to the control group.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Relapse-free survival (RFS)
Time Frame
5 years
Title
Overall survival (OS)
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥ 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 Exclusion Criteria: ≤ 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric C Anderson, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Legacy Mount Hood Medical Center
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Legacy Good Samaritan Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Legacy Meridian Park Medical Center
City
Tualatin
State/Province
Oregon
ZIP/Postal Code
97062
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20945439
Citation
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Results Reference
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Citation
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PubMed Identifier
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Citation
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Results Reference
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Effectiveness of High Dose Vitamin D Supplementation in Stage III Colorectal Cancer

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