Clinical trial · Interventional
Cholecalciferol in Improving Survival in Patients With Newly Diagnosed Cancer With Vitamin D Insufficiency
Effect of Vitamin D Replacement on Tumor Response and Survival Parameters for Vitamin D Insufficient Patients With Cancer
NCT01787409CI-TRIAL-00114932active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (15)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aggressive Non-Hodgkin Lymphoma | Aggressive Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Anaplastic Large Cell Lymphoma | Anaplastic Large Cell Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Angioimmunoblastic T-Cell Lymphoma | Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type | ALIAS | 0.90 |
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Diffuse Large B-Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Enteropathy-Associated T-Cell Lymphoma | Enteropathy-Associated T-Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Hepatosplenic T-Cell Lymphoma | Hepatosplenic T-Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma | Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cholecalciferol | Dietary Supplement | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (cholecalciferol)
- description
- 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.
- interventionNames
- Dietary Supplement: Cholecalciferol
- Other: Laboratory Biomarker Analysis
Primary outcomes (2)
- measure
- Event free survival (EFS) (Study I)
- timeFrame
- Time from study registration to lymphoma progression, initiation of new anti-lymphoma therapy after completion or cessation of the original anthracycline based treatment, or death due to any cause, assessed at 12 months
- description
- The proportion of successes will be estimated separately in the groups by the number of successes divided by the total number of evaluable patients. 95% confidence intervals for the true success proportion will be calculated by the exact binomial method.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Newly diagnosed aggressive lymphoma or CLL/small lymphocytic lymphoma (SLL) that meets disease specific criteria below:
* Study 1 - Aggressive lymphoma
* Newly diagnosed de-novo DLBCL or primary mediastinal B-cell lymphoma that will be treated with an anthracycline-containing regimen (rituximab-cyclophosphamide, doxorubicin hydrochloride, prednisone \[R-CHOP\] or equivalent); patients with composite lymphomas can also be enrolled as long as they have large cell component and will be treated with an anthracycline; in addition, patients with "B cell lymphoma, unclassifiable, with features intermediate between diffuse large B cell lymphoma and Burkitt lymphoma" or post-transplant DLBCL are also eligible as long as they meet other criteria; patients with typical Burkitt lymphoma are not eligible
* NOTE: patients can be enrolled up through day 1 of cycle 3 of therapy; the patient is permitted to participate in any other therapeutic therapy for their disease as long as it does not concern vitamin D; patients can begin their chemotherapy while awaiting vitamin D results and treatment arm assignment or
* Newly diagnosed untreated peripheral T-cell non-Hodgkin lymphoma (NHL) that will be treated with chemotherapy; NOTE: patients can be enrolled up through day 1 of cycle 3 of therapy; this includes the following disease types:
* Peripheral T cell lymphoma, unspecified
* Anaplastic large cell lymphoma (T and null cell type)
* Extranodal NK/T-cell lymphoma, nasal type
* Enteropathy-type T-cell lymphoma
* Hepatosplenic T-cell lymphoma
* Subcutaneous panniculitis-like T-cell lymphoma
* Angioimmunoblastic T-cell lymphoma
* Anaplastic large cell lymphoma - primary cutaneous type and
* Willing to provide tissue for correlative research purposes
* Study 2 - CLL/SLL
* Newly diagnosed (\< 12 months from pre-registration on this study) CLL according to the National Cancer Institute (NCI) criteria or SLL according to the World Health Organization (WHO) criteria; this includes previous documentation of:
* Biopsy-proven small lymphocytic lymphoma
* Diagnosis of CLL according to NCI working group criteria as evidenced by all of the following:
* Peripheral blood lymphocyte count of \> 5,000/mm\^3; if present, prolymphocytes should be \< 55%
* Immunophenotyping consistent with CLL defined as:
* The predominant population of lymphocytes share both B-cell antigens (cluster of differentiation \[CD\]19, CD20, or CD23) as well as CD5 in the absence of other pan-T-cell markers (CD3, CD2, etc.)
* Dim surface immunoglobulin expression
* Restricted surface kappa or lambda light chain expression
* Before diagnosing CLL or SLL, mantle cell lymphoma must be excluded by demonstrating a negative fluorescent in situ hybridization (FISH) analysis for t(11;14)(immunoglobulin H \[IgH\]/cyclin D 1 \[CCND1\]) on peripheral blood or tissue biopsy or negative immunohistochemical stains for cyclin D1 on involved tissue biopsy
* Rai stage 0 or 1
* Previously untreated
* Asymptomatic with the plan for observation
* Life expectancy of at least 24 months
* Willing to provide tissue for correlative research purposes
* Both Studies:
* Capable of swallowing intact study medication capsules
* Serum calcium \< 11 mg/dL; note: patients with hypercalcemia can be enrolled after the calcium is corrected with standard of care treatments
* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
* Note: During the Active Monitoring Phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up
* Willing to provide blood samples for correlative research purposes
* Vitamin D level (25 hydroxy D2 + hydroxyl D3) confirmed by central laboratory review
Exclusion Criteria:
* Patients with Burkitt lymphoma or any patient receiving rituximab-cyclophosphamide, vincristine, doxorubicin, high-dose methotrexate / ifosfamide, etoposide, high-dose cytarabine (R- CODOXM/IVAC)
* Patients who previously had indolent lymphoma and now at a separate episode have large cell NHL (i.e. transformationReferences
Publications (0)
Data not yet available
No reference posted for this study.