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High-Dose Vitamin D3 for Colon Cancer

Phase < 1

Recruiting

Led By Kimmie Ng, MD, MPH

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

Participants must have histologically confirmed adenocarcinoma of the colon that is localized, with no evidence of distant metastasis (stage I, II, or III), and for which surgical resection of the primary tumor is being planned

Must not have

Pregnant or nursing women or men/women of child-bearing potential who are unwilling to employ adequate contraception

Inability to swallow pills

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 to 28 days

Summary

This trial is testing if high-dose vitamin D will help treat colon cancer by binding to the vitamin D receptor in cancer cells.

Who is the study for?

This trial is for adults with stage I-III colon cancer or resectable liver metastases from colon cancer, who haven't had recent chemotherapy or radiation. They must be able to swallow pills, not have a history of allergic reactions to vitamin D, and should not be on certain medications like thiazide diuretics. Pregnant women and those unable to use contraception are excluded.

What is being tested?

The study tests high-dose versus standard-dose vitamin D given before surgery for colon cancer. It aims to understand how vitamin D affects the growth and death of cancer cells by interacting with the vitamin D receptor in these cells.

What are the potential side effects?

Potential side effects may include hypercalcemia (high calcium levels), digestive issues that affect pill absorption, allergic reactions if sensitive to vitamin D compounds, and possibly an increased risk of kidney stones.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My colon cancer is confirmed, hasn't spread far, and surgery is planned.

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I have colon cancer with liver metastases that can be surgically removed.

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I have not had radiation or systemic treatment for my stage I, II, or III colon cancer.

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I am fully active and can carry on all pre-disease activities without restriction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or nursing and willing to use contraception if of child-bearing age.

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I cannot swallow pills.

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I regularly take water pills for my blood pressure or swelling.

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I haven't had chemotherapy or radiotherapy within 4 weeks before my liver surgery.

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I have a history of poor nutrient absorption or uncontrolled stomach/intestine issues.

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I am taking medication that can lower my vitamin D levels.

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I have an active condition affecting my calcium levels.

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I have had painful kidney or bladder stones in the last year.

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I do not have any uncontrolled illnesses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 to 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 to 28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 to 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

VDR Binding Sites

Secondary study objectives

Changes in TME

Number of Participants with Serious and Non-Serious Adverse Events

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Vitamin D3 - Blinded RegistrationExperimental Treatment1 Intervention

One capsule of vitamin D3 10,000 IU orally once daily for 14 days until the date of surgery. To allow for some flexibility in the scheduling of surgery, patients can be treated with preoperative vitamin D3 for up to 28 days. On the morning of surgery, prior to operating, a second blood sample will be collected for follow-up 25(OH)D, calcium, and albumin determination. Colon and liver resection will occur per institutional standards of care, and malignant and adjacent benign tissue will be collected for the laboratory endpoints described in this protocol.

Group II: Placebo - Blinded RegistrationPlacebo Group1 Intervention

One placebo capsule orally once daily for 14 days until the date of surgery. To allow for some flexibility in the scheduling of surgery, patients can be treated with preoperative placebo for up to 28 days. On the morning of surgery, prior to operating, a second blood sample will be collected for follow-up 25(OH)D, calcium, and albumin determination. Colon and liver resection will occur per institutional standards of care, and malignant and adjacent benign tissue will be collected for the laboratory endpoints described in this protocol.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vitamin D3

2011

Completed Phase 4

~3590

0 / 14Eligibility criteria met