Trial Summary
What is the purpose of this trial?This partially randomized clinical trial studies cholecalciferol in improving survival in patients with newly diagnosed cancer with vitamin D insufficiency. Vitamin D replacement may improve tumor response and survival and delay time to treatment in patients with cancer who are vitamin D insufficient.
Is the drug Cholecalciferol (Vitamin D3) a promising treatment for lymphoma?Yes, Cholecalciferol (Vitamin D3) shows promise as a treatment for lymphoma. Studies suggest that higher vitamin D levels may be linked to better survival rates in certain types of lymphoma, like extranodal natural killer/T-cell lymphoma. Additionally, vitamin D might help reduce the risk of developing non-Hodgkin lymphoma by supporting healthy cell functions.237910
What data supports the idea that Vitamin D for Lymphoma is an effective treatment?The available research shows that higher levels of Vitamin D might be linked to better outcomes for some types of lymphoma. For example, one study found that low Vitamin D levels were associated with worse survival in patients with follicular lymphoma. Another study indicated that Vitamin D deficiency was linked to poorer survival in patients with a specific type of lymphoma called extranodal natural killer/T-cell lymphoma. However, the research is not entirely conclusive, and more studies are needed to fully understand the role of Vitamin D in treating lymphoma.457810
What safety data exists for Vitamin D treatment in lymphoma?The research does not directly address safety data for Vitamin D treatment in lymphoma. However, one study on murine lymphoma suggests that Vitamin D3 (Cholecalciferol) may have anticlastogenic properties, potentially reducing chromosomal aberrations and increasing survival time in mice. This indicates a possible antineoplastic effect, but specific safety data for human clinical trials is not provided in the available research.124610
Do I need to stop my current medications for the Vitamin D for Lymphoma trial?The trial protocol does not specify if you need to stop your current medications. However, you can participate in other therapies for your disease as long as they don't involve vitamin D.
Eligibility Criteria
This trial is for newly diagnosed patients with aggressive lymphoma or chronic lymphocytic leukemia/small lymphocytic lymphoma who can swallow capsules, are willing to return for follow-up and provide blood samples. They must have normal serum calcium levels and confirmed vitamin D insufficiency.Inclusion Criteria
I have been recently diagnosed with aggressive lymphoma or CLL/SLL.
I can swallow pills without any issues.
Treatment Details
The study tests if cholecalciferol (a form of vitamin D) improves survival, tumor response, and delays treatment in cancer patients with low vitamin D. It's a partially randomized trial that includes laboratory biomarker analysis to monitor effects.
1Treatment groups
Experimental Treatment
Group I: Treatment (cholecalciferol)Experimental Treatment2 Interventions
Vitamin D sufficient patients receive no intervention. Vitamin D insufficient patients receive cholecalciferol PO once weekly for 12 weeks and then once monthly for a total of 36 months.
Cholecalciferol is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:
🇺🇸 Approved in United States as Vitamin D3 for:
- Prevention and treatment of vitamin D deficiency
- Osteoporosis prevention
- Rickets prevention
🇪🇺 Approved in European Union as Cholecalciferol for:
- Prevention and treatment of vitamin D deficiency
- Osteoporosis prevention
- Rickets prevention
🇨🇦 Approved in Canada as Vitamin D3 for:
- Prevention and treatment of vitamin D deficiency
- Osteoporosis prevention
- Rickets prevention
🇯🇵 Approved in Japan as Cholecalciferol for:
- Prevention and treatment of vitamin D deficiency
- Osteoporosis prevention
- Rickets prevention
🇨🇳 Approved in China as Vitamin D3 for:
- Prevention and treatment of vitamin D deficiency
- Osteoporosis prevention
- Rickets prevention
🇨🇭 Approved in Switzerland as Cholecalciferol for:
- Prevention and treatment of vitamin D deficiency
- Osteoporosis prevention
- Rickets prevention
Find a clinic near you
Research locations nearbySelect from list below to view details:
Mayo Clinic in ArizonaScottsdale, AZ
University of Iowa/Holden Comprehensive Cancer CenterIowa City, IA
Emory University/Winship Cancer InstituteAtlanta, GA
Mayo ClinicRochester, MN
More Trial Locations
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Anticlastogenic potential of 1alpha,25-dihydroxyvitamin D3 in murine lymphoma. [2019]Vitamin D3, having gained scientific interest for so long because of its role in mineral homeostasis, has now received great importance as a possible antitumor agent. This study was undertaken in an attempt to visualize the possible anticlastogenic potential of the vitamin in an ascitic mouse lymphoma model namely, Dalton's lymphoma. Frequencies of structural type chromosomal aberrations, sister chromatid exchanges and micronucleus assays have been chosen as the genotoxic endpoints in the proposed investigation. All these cytogenetic markers have been found to be markedly elevated during the progression of lymphoma in bone marrow cells. Vitamin D3 effectively suppressed the frequencies of chromosomal aberrations and sister chromatid exchanges in the lymphoma-bearing mice during the entire phase of tumor growth that significantly coupled with almost two-fold increase in survival time (37 +/- 2 and 68 +/- 2 days in lymphoma controls and vitamin D3-treated lymphoma-bearing mice, respectively), thus substantiating the antineoplastic efficacy of this secosteroid. The outcome of this study also is clearly reflected in the depletion of circulating (serum) vitamin D3 levels in the lymphoma control mice compared with normal (vehicle) controls while a still higher level was maintained in the VD3-treated lymphoma mice. This anticlastogenic property of the vitamin has so far been neglected and this is the first attempt to unravel the vitamin D3's effect in combating tumor development in vivo by limiting the frequencies of chromosomal aberrations, sister chromatid exchanges and micronuclei at least in transplantable murine model studied herein.
A prospective investigation of serum 25-hydroxyvitamin D and risk of lymphoid cancers. [2021]Studies indicate that higher sun exposure, especially in the recent past, is associated with reduced risk of non-Hodgkin lymphoma (NHL). Ultraviolet radiation-derived vitamin D may be protective against lymphomagenesis. We examined the relationship between prediagnostic serum 25-hydroxyvitamin D (25(OH)D) and lymphoid cancer risk in a case-control study nested within the Alpha-Tocopherol Beta-Carotene Cancer Prevention Study cohort (1985-2002) of 29,133 Finnish male smokers (ages 50-69). We identified 270 incident lymphoid cancer cases and matched them individually with 538 controls by birth-year and month of fasting blood draw at baseline. In conditional logistic regression models for 10 nmol/L increments or tertile comparisons, serum 25(OH)D was not associated with the risk of overall lymphoid cancers, NHL (n = 208) or multiple myeloma (n = 41). Odds ratios (OR) for NHL for higher tertiles were 0.75 (95% confidence interval (CI), 0.50, 1.14) and 0.82 (95% CI, 0.53, 1.26). The 25(OH)D-NHL association, however, differed by follow-up duration at diagnosis. Cases diagnosed less than 7 years from the baseline showed an inverse association (OR for highest vs. lowest tertile = 0.43; 95% CI: 0.23, 0.83; p for trend = 0.01), but not later diagnoses (OR = 1.52; 95% CI: 0.82, 2.80; p for trend = 0.17). The inverse association found for close exposure to diagnosis was not confounded by other risk factors for lymphoma or correlates of 25(OH)D. Although our findings suggest that circulating 25(OH)D is not likely associated with overall lymphoid cancer, they indicate a potentially protective effect on short-term risk of NHL.
Vitamin D and non-Hodgkin lymphoma risk in adults: a review. [2021]Animal and human studies support a protective effect of vitamin D sufficiency related to malignancy by uncovering paracrine and autocrine effects of extra-renal 25-hydroxyvitamin D (25(OH)D) activation including regulation of cell cycle proliferation, apoptosis induction, and increased cell differentiation signaling. Recent epidemiologic studies demonstrate a reduction in non-Hodgkin lymphoma (NHL) risk with increased sunlight exposure. As sunlight is a major vitamin D source, it has been suggested that vitamin D status may mediate this observed association. This review provides a comprehensive discussion of the current epidemiologic evidence with regard to the investigation of an association between vitamin D status and NHL risk.
Plasma 25-hydroxyvitamin D concentration and lymphoma risk: results of the European Prospective Investigation into Cancer and Nutrition. [2023]The relation between vitamin D status and lymphoma risk is inconclusive.
Low Serum Vitamin D Levels Are Associated With Inferior Survival in Follicular Lymphoma: A Prospective Evaluation in SWOG and LYSA Studies. [2022]Recent literature reports a potential association between high vitamin D and improved lymphoma prognosis. We evaluated the impact of pretreatment vitamin D on follicular lymphoma (FL) outcome.
Vitamin D levels in Swiss breast cancer survivors. [2018]Cholecalciferol (vitamin D3) is widely supplemented in breast cancer survivors because of the role of vitamin D in multiple health outcomes.
Vitamin D deficiency is associated with inferior survival of patients with extranodal natural killer/T-cell lymphoma. [2022]Vitamin D deficiency is a common health issue; however, the effect of vitamin D deficiency on the survival of T-cell lymphoma is still not clear. We evaluated the impact of serum vitamin D level of patients with peripheral T-cell lymphoma (PTCL) and extranodal natural killer/T-cell lymphoma (ENKTL) on survival outcome. Pretreatment levels of 25-hydroxyvitamin D [25(OH)D] and inflammatory cytokines were measured in serum samples that were archived at diagnosis, and we evaluated their association with survival in newly diagnosed patients with PTCL (n = 137) and ENKTL (n = 114) at a university-based hospital in Korea. An independent cohort from Rui Jin Hospital (Shanghai, China) was used for validation. The median 25(OH)D serum level was 12.0 ng/mL (1.3-60.0 ng/mL), and 40% had less than 10 ng/mL, which was defined as vitamin D deficiency. Median serum 25(OH)D levels were similar between PTCL (11.5 ng/mL) and ENKTL (12.9 ng/mL); however, vitamin D deficiency was associated with inferior survival in ENKTL but not with PTCL. The independent validation cohort (n = 115) also showed a significant association of vitamin D deficiency with poor survival in ENKTL. The 25(OH)D level had an inverse relation with inflammatory cytokines; this association had a negative effect only on survival of ENKTL, and not on PTCL. In conclusion, vitamin D deficiency was associated with inferior survival outcome of patients with ENKTL.
Bioavailable 25(OH)D level is associated with clinical outcomes of patients with diffuse large B-cell lymphoma: An exploratory study. [2021]Vitamin D insufficiency is associated with worse clinical outcomes in multiple cancer types; however, its roles in diffuse large B-cell lymphoma (DLBCL) patients are still unclear. Here, we aimed to determine the prognostic values of circulating total 25(OH)D and bioavailable 25(OH)D levels in DLBCL patients.
Vitamin D levels in patients with non-Hodgkin lymphoma/diffuse large B-cell lymphoma, chronic lymphocytic leukemia and multiple myeloma. [2021]To investigate serum vitamin D levels in patients newly diagnosed with non-Hodgkin lymphoma/diffuse large B-cell lymphoma (NHL-DLBCL), multiple myeloma (MM) and chronic lymphocytic leukemia (CLL).
A Systematic Review Assessing the Impact of Vitamin D Levels on Adult Patients with Lymphoid Malignancies. [2023]Vitamin D deficiency has been correlated with various conditions, including the risk of developing lymphoid malignancies. This systematic review aimed to assess the association between vitamin D levels at diagnosis of lymphoid malignancies, patient outcomes, and survival. A systematic review was conducted, encompassing 15 studies published until January 2023, involving 4503 patients, examining the relationship between vitamin D and lymphoid cancers. The median age of the patients was 56.5 years, with a median follow-up duration of approximately 36 months across studies. The overall median vitamin D level at initial measurement was 20.4 ng/mL, while a