Clinical trial · Interventional
Vitamin Supplementation in NSCLC Patients on Pemetrexed Based Chemotherapy
Optimum Duration of Vitamin B12 and Folate Supplementation in Non-squamous Non-small Cell Lung Cancer (NSCLC) Patients Undergoing Pemetrexed Containing Chemotherapy: a Randomized Controlled Trial
- 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)
Folic acid (FA; folate) in the dose of 350-1,000 μg daily should be supplemented, daily, starting 7 days before the first dose of pemetrexed based chemotherapy and should be continued while the patient is on therapy and for 21 days after cessation of therapy. Vitamin B12 injections (1,000 μg i.m.) should also be started 1 week before the first dose of chemotherapy. However, the evidence for delaying chemotherapy by seven days for the purpose of giving vitamin B12 and FA supplementation is not robust. Observational and prospective single arm studies have not shown any increased toxicity if pemetrexed was started earlier than the recommended duration of supplementation. In a resource constrained setting, this will lead to one additional visit and 1-week chemotherapy delay which may be inconvenient for patients. Hence an open label, randomized control trial is being undertaken to evaluate if there are any differences in pemetrexed related hematological toxicity amongst patients who receive delayed initiation of chemotherapy (following 5 - 7 days of vitamin B12 and FA supplementation; Delayed Arm) as compared to those in whom vitamin B12 and FA supplementation is starting simultaneously (within 24 hours) of initiation of chemotherapy (Immediate Arm).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Lung Adenocarcinoma | Lung Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Neutropenia | — | UNRESOLVED | — |
| Nonsquamous Nonsmall Cell Neoplasm of Lung | — | UNRESOLVED | — |
| Thrombocytopenia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Folate and B12 | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Delayed Arm
- description
- Participants are started on folate and vitamin B12 supplementation for 5-7 days prior to initiation of chemotherapy
- type
- EXPERIMENTAL
- label
- Immediate Arm
- description
- Participants are started on folate and vitamin B12 supplementation simultaneously with chemotherapy (within 24 hours of initiation of chemotherapy)
- interventionNames
- Dietary Supplement: Folate and B12
Primary outcomes (1)
- measure
- Incidence of any grade hematological toxicity
- timeFrame
- Completion of six cycles (average of 18 weeks; each cycle is 21 days) of pemetrexed-platinum doublet chemotherapy
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Locally advanced or metastatic (Stage IIIB/IV) NSCLC and Stage III A NSCLC, not scheduled for upfront surgical resection * Nonsquamous histology (including adenocarcinoma) * At least one unidimensionally measurable lesion, according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.0), or at least one nonmeasurable lesion that was assessable using conventional techniques or a spiral computed tomography scan * An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * No previous chemotherapy for advanced disease and no previous targeted molecular therapy * Adequate liver and renal function; * Previous radiation therapy is permitted if completed \>4 weeks before enrollment and the patient has recovered from any treatment-related toxicity. Exclusion Criteria: * Hemoglobin value \< 9gm/dl * Required erythropoiesis stimulating agents or blood transfusions in the recent past (4 months) * Symptomatic untreated brain metastasis * Any previous malignancy * Concurrent use of any other tumor therapy * Active infection or a serious concomitant disorder * Inability to interrupt nonsteroidal anti-inflammatory agents * Inability or unwillingness to take folic acid, vitamin B12, or dexamethasone supplementation * Pregnancy or breast feeding
References
Publications (2)
- DERIVEDSingh N, Baldi M, Kaur J, Muthu V, Prasad KT, Behera D, Bal A, Gupta N, Kapoor R. Timing of folic acid/vitamin B12 supplementation and hematologic toxicity during first-line treatment of patients with nonsquamous non-small cell lung cancer using pemetrexed-based chemotherapy: The PEMVITASTART randomized trial. Cancer. 2019 Jul 1;125(13):2203-2212. doi: 10.1002/cncr.32028. Epub 2019 Mar 2. PMID 30825389
- DERIVEDBaldi M, Behera D, Kaur J, Kapoor R, Singh N. Rationale and Design of PEMVITASTART-An Open-label Randomized Trial Comparing Simultaneous Versus Standard Initiation of Vitamin B12 and Folate Supplementation in Nonsquamous, Non-Small-cell Lung Cancer Patients Undergoing First-line Pemetrexed-based Chemotherapy. Clin Lung Cancer. 2017 Jul;18(4):432-435. doi: 10.1016/j.cllc.2016.11.017. Epub 2016 Dec 2. PMID 28073680