Vitamin D for Lymphoma

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Nebraska

Disqualifiers: Allergic reactions, Paget's disease, Hypercalcemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether cholecalciferol (a type of vitamin D) can boost vitamin D levels and improve survival for people with non-Hodgkin lymphoma or chronic lymphocytic leukemia. Participants will join one of three groups: one receiving high-dose cholecalciferol, another receiving low-dose cholecalciferol, and a control group receiving no additional treatment. The trial seeks participants recently diagnosed with these conditions who have low vitamin D levels but have not yet undergone significant treatment. As an unphased trial, this study offers a unique opportunity to contribute to understanding the potential benefits of vitamin D in cancer care.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that cholecalciferol, a type of vitamin D, is generally well-tolerated by the body. Both high and low doses of vitamin D supplements are often used to boost vitamin D levels. While vitamin D is safe for most people, excessive intake can lead to hypercalcemia, an excess of calcium in the blood, which can affect bones and cause other health issues. These side effects are rare and typically occur only with excessive intake.

Studies also suggest that taking vitamin D does not significantly increase the risk of serious cancer or heart problems compared to a placebo. For individuals with lymphoma, low vitamin D levels are linked to lower survival rates, indicating that vitamin D supplementation might be beneficial. Overall, vitamin D supplements like cholecalciferol are considered safe for most people, especially when taken under a doctor's guidance. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using cholecalciferol, a form of vitamin D, for treating lymphoma because it introduces a new approach compared to the standard options like chemotherapy and radiation. Unlike traditional treatments, which can be harsh and have significant side effects, cholecalciferol is a natural compound that may offer a gentler alternative. The trial explores both high-dose and low-dose regimens to assess effectiveness, marking a shift towards potentially safer long-term management of lymphoma. This exploration of vitamin D's role could open new pathways for treating the disease with fewer side effects.

What evidence suggests that this trial's treatments could be effective for lymphoma?

This trial will compare the effects of different doses of cholecalciferol (vitamin D3) on lymphoma outcomes. Research has shown that vitamin D, particularly in the form of cholecalciferol, may improve outcomes for some cancer patients. One study found that patients with sufficient vitamin D levels after supplementation experienced better results. Another study found that vitamin D intake reduced cancer-related deaths, although it did not decrease the overall number of cancer cases. However, some research found no benefit from regular vitamin D supplements for patients with slow-growing lymphoma treated with rituximab. Overall, while not all studies agree, evidence suggests that vitamin D might help cancer patients live longer, especially those with vitamin D deficiency. ^{1 3 6 7 8}

Who Is on the Research Team?

Julie M Vose, MD, MBA

Principal Investigator

University of Nebraska

Are You a Good Fit for This Trial?

This trial is for newly diagnosed or untreated patients with non-Hodgkin lymphoma or chronic lymphocytic leukemia who also have vitamin D deficiency. They can join even if they're on 'wait and watch' therapy, had up to two chemo cycles, or localized radiation. However, those with a history of severe allergic reactions to vitamin D, Paget's disease, high calcium levels in the blood, or conditions that could affect protocol adherence cannot participate.

Inclusion Criteria

I have newly diagnosed or untreated non-Hodgkin’s lymphoma or CLL.

Patients must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts

You can participate in other clinical trials for different treatments at the same time.

Exclusion Criteria

You have any other medical condition or mental illness that may make it difficult for you to follow the study protocol or understand the information provided to you.

Inability to cooperate with the requirements of the protocol

Hypercalcemia

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either high-dose or low-dose cholecalciferol orally daily for 3 years

3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cholecalciferol

Trial Overview The study tests how well Cholecalciferol (a form of Vitamin D) works alongside standard chemotherapy in improving survival rates for patients with certain types of leukemia and lymphoma who are deficient in Vitamin D. It's an early phase I trial where some participants will receive Cholecalciferol while their responses are monitored through lab analysis.

How Is the Trial Designed?

Group I: Arm II (low-dose cholecalciferol) Experimental Treatment 2 Interventions

Patients receive low-dose cholecalciferol PO daily for 3 years in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (high-dose cholecalciferol) Experimental Treatment 2 Interventions

Patients receive high-dose cholecalciferol PO daily for 3 years in the absence of disease progression or unacceptable toxicity.

Group III: Arm III (control) Active Control 1 Intervention

Patients receive no intervention.

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5773978/

Vitamin D deficiency and supplementation in patients with ... Our study provides the first evidence that achievement of normal 25(OH)D levels after vitamin D3 supplementation is associated with improved outcome in patients ...

2. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00538-8/fulltext

Vitamin D in patients with low tumor-burden indolent non ... As tested in this study, there is no benefit to routine vitamin D supplementation in patients with indolent lymphoma treated with rituximab.

3. mdpi.com mdpi.com/1718-7729/30/4/331

A Systematic Review Assessing the Impact of Vitamin D ... This systematic review aimed to assess the association between vitamin D levels at diagnosis of lymphoid malignancies, patient outcomes, and survival.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05450419

The Role of Vitamin D3 Supplementation in Advanced ... A cross-sectional study showed positive correlation of vitamin D status with absence of fatigue and improved physical and functional well-being in 30 advanced ...

5. annalsofoncology.org annalsofoncology.org/article/s0923-7534(19)31159-7/fulltext

Vitamin D supplementation and total cancer incidence ... In an updated meta-analysis of RCTs, vitamin D supplementation significantly reduced total cancer mortality but did not reduce total cancer incidence.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK557876/

Vitamin D Toxicity - StatPearls - NCBI Bookshelf Toxicity of vitamin D leads to hypercalcemia and an imbalance in the regulation of bone metabolism; the resultant hypercalcemia leads to clinical ...

7. nejm.org nejm.org/doi/full/10.1056/NEJMoa1809944

Vitamin D Supplements and Prevention of Cancer ... Supplementation with vitamin D did not result in a lower incidence of invasive cancer or cardiovascular events than placebo.

8. mdpi.com mdpi.com/1718-7729/32/3/135

Influence of Vitamin D and Its Analogues in Type-B ... In conclusion, higher levels of circulating VitD are related to improved OS, reduced cancer-specific mortality, and better disease-free survival. VitD and ...