Phase II study of oral vitamin B12 supplementation as an alternative to intramuscular injection for patients with non-small cell lung cancer undergoing pemetrexed therapy

Takagi, Yusuke; Hosomi, Yukio; Nagamata, Makoto; Watanabe, Kageaki; Takahashi, Satoshi; Nakahara, Yoshiaki; Yomota, Makiko; Sunami, Kuniko; Okuma, Yusuke; Shimokawa, Tsuneo; Okamura, Tatsuru

doi:10.1007/s00280-015-2954-x

Cited by 7 publications

(16 citation statements)

References 12 publications

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“…As a therapeutic agent, folic acid has been used in various combinations showing modest effects in preventing colorectal cancer [166], or in preventing secondary effects of chemotherapy for lung cancer [167]. Unfortunately, little to no effects have been shown in the prevention of colorectal adenomas [168].…”

Section: Vitaminsmentioning

confidence: 99%

Role of Key Micronutrients from Nutrigenetic and Nutrigenomic Perspectives in Cancer Prevention

et al. 2019

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Regarding cancer as a genetic multi-factorial disease, a number of aspects need to be investigated and analyzed in terms of cancer’s predisposition, development and prognosis. One of these multi-dimensional factors, which has gained increased attention in the oncological field due to its unelucidated role in risk assessment for cancer, is diet. Moreover, as studies advance, a clearer connection between diet and the molecular alteration of patients is becoming identifiable and quantifiable, thereby replacing the old general view associating specific phenotypical changes with the differential intake of nutrients. Respectively, there are two major fields concentrated on the interrelation between genome and diet: nutrigenetics and nutrigenomics. Nutrigenetics studies the effects of nutrition at the gene level, whereas nutrigenomics studies the effect of nutrients on genome and transcriptome patterns. By precisely evaluating the interaction between the genomic profile of patients and their nutrient intake, it is possible to envision a concept of personalized medicine encompassing nutrition and health care. The list of nutrients that could have an inhibitory effect on cancer development is quite extensive, with evidence in the scientific literature. The administration of these nutrients showed significant results in vitro and in vivo regarding cancer inhibition, although more studies regarding administration in effective doses in actual patients need to be done.

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Section: Vitaminsmentioning

confidence: 99%

Role of Key Micronutrients from Nutrigenetic and Nutrigenomic Perspectives in Cancer Prevention

et al. 2019

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“…Reduction in homocysteine levels with continued supplementation was also observed in another small prospective study. 29 It needs to be emphasized here that it is important to deliver vitamin B12 by the intramuscular route and not orally. 29 Can the results of this trial be applied straightaway to routine clinical practice?…”

Section: Discussionmentioning

confidence: 99%

“…29 It needs to be emphasized here that it is important to deliver vitamin B12 by the intramuscular route and not orally. 29 Can the results of this trial be applied straightaway to routine clinical practice? The answer is both yes and no: Yes , because this randomized, prospective trial was conducted in a real world setting with appropriate practical primary and secondary endpoints; but no , because the trial excluded patients who had pre-existing hemoglobin levels ≤9 g/dL and those who had received prior treatment for anemia.…”

Section: Discussionmentioning

confidence: 99%

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

Singh

Baldi

Kaur

et al. 2019

Cancer

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Background Vitamin B12 and folic acid (FA) supplementation (B12‐FAS) reduces hematologic toxicity with pemetrexed‐based chemotherapy (PEM). However, the basis for recommending 1 week of B12‐FAS before PEM initiation has never been proven in a randomized trial. Methods An open‐label, randomized trial (PEMVITASTART; clinicaltrials.gov identifier NCT02679443) was conducted to compare hematologic toxicity between patients with locally advanced/metastatic nonsquamous non–small cell lung cancer who initiated PEM after 5 to 7 days of B12‐FAS (delayed arm [DA]) versus those who received B12‐FAS simultaneously (≤24 hours) with PEM initiation (immediate arm [IA]). Every 3 weeks, all enrolled patients received pemetrexed (500 mg/m2) AND either cisplatin (65 mg/m2) OR carboplatin (area under the curve = 5.0 mg/mL per minute) on day 1 for a maximum of 6 cycles. Supplementation consisted of oral FA 1000 μg daily and intramuscular vitamin B12 1000 μg every 3 weeks. The primary outcome was any grade of hematologic toxicity and secondary outcomes included grade 3/4 hematologic toxicity, the relative dose intensity delivered, and changes in serum levels of B12/FA/homocysteine. Results Of 161 patients (IA, n = 81; DA, n = 80) recruited, 150 (IA, n = 77; DA, n = 73) received ≥1 cycle and were included in a modified intention‐to‐treat analysis. Baseline anemia prevalence was 34.7% (IA, 32.5%; DA, 37%; P = .56). The incidence of any grade anemia, leukopenia, neutropenia, and thrombocytopenia was 87% versus 87.7% (P = .90), 37.7% versus 28.8% (P = .25), 20.8% versus 15.1% (P = .36), and 31.2% versus 16.4% (P = .04), respectively, in the IA and DA, respectively. Grade 3/4 cytopenias and median relative dose intensities delivered (pemetrexed, 93.5%; platinum, 91%) were similar in both arms. After cycle 3 (compared with baseline), serum homocysteine levels were lower, whereas FA and B12 levels were higher. In the DA, serum FA and B12 levels on day 1 of cycle 1 (after 5‐7 days of B12‐FAS) were significantly higher than at baseline, but homocysteine levels were similar. Conclusions Simultaneous B12‐FAS initiation with a pemetrexed‐platinum doublet chemotherapy regimen is feasible and does not lead to enhanced hematologic toxicity. Serum homocysteine levels are unaffected by 5 to 7 days of B12‐FAS.

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“…The 48 articles were classified into the following categories: full text peer-reviewed manuscripts (n = 38), conference abstracts (n = 8), and clinical trial registrations (n = 2). Of the full text peer-reviewed manuscripts, the majority reported on randomized controlled trials (RCTs) (n = 18) [34][35][36][37][38][39][40][41][42][43][44][45][46][47][48][49][50][51], followed by quasi-experimental trials (n = 15) [52][53][54][55][56][57][58][59][60][61][62][63][64][65][66], retrospective cohort observational studies (n = 2) [67,68], and case studies (n = 3) [69][70][71]. Conference abstracts reported on RCTs (n = 3) [72][73][74], quasi-experimental trials (n = 4) [75][76][77][78], and a case study (n = 1) [79].…”

Section: Study Characteristicsmentioning

confidence: 99%

“…Vitamins included in studies were vitamin A (n = 2) [44,54], B1 (n = 1) [76], B6 (n = 2) [70,76], B9 (n = 4) [46,60,61,68], B12 (n = 1) [60], C (n = 2) [44,54], D (n = 4) [40,59,62,64], and E (n = 3) [39,44,54]. Minerals included were calcium (n = 2) [62,64], iron (n = 2) [68,79], and selenium (n = 1) [75].…”

Section: Vitamins Minerals and Other Antioxidantsmentioning

confidence: 99%

Dietary Supplements in People with Metastatic Cancer Who Are Experiencing Malnutrition, Cachexia, Sarcopenia, and Frailty: A Scoping Review

et al. 2022

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Cancer-associated malnutrition, or cachexia, stemming from cancer or its treatments, is particularly prevalent in metastatic cancers, and is often interrelated with sarcopenia and frailty. Evidence suggests that dietary supplements play a role in managing these conditions. As metastatic cancer cells are associated with notable genomic and phenotypic alterations, response to dietary supplements may differ between metastatic and non-metastatic cancers. However, research in this area is lacking. This scoping review aims to identify the dietary supplements that have been studied in patients with metastatic cancers and malnutrition-related conditions, along with their proposed effects, mechanisms, outcome measures, and tools used. A systematic search was conducted across databases, including MEDLINE, EMBASE, CINAHL, and clinical trial registries. Of the initial 6535 records screened, a total of 48 studies were included, covering a range of dietary supplements—vitamins, minerals, antioxidants, proteins, amino acids, fatty acids, fiber, and others. While the types of dietary supplements included varied across cancer types, omega-3 and carnitine were investigated most often. Proposed relevant attributes of dietary supplements included their antioxidant, anti-inflammatory, anti-cancer, and immunomodulatory properties. Overall, there was a paucity of interventional studies, and more randomized controlled trials are warranted.

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Phase II study of oral vitamin B12 supplementation as an alternative to intramuscular injection for patients with non-small cell lung cancer undergoing pemetrexed therapy

Abstract: This study failed to meet its primary endpoint. We could not demonstrate the safety and efficacy of the 1-week vitamin B12 oral administration protocol as compared with intramuscular administration.

Cited by 7 publications

References 12 publications

Role of Key Micronutrients from Nutrigenetic and Nutrigenomic Perspectives in Cancer Prevention

Role of Key Micronutrients from Nutrigenetic and Nutrigenomic Perspectives in Cancer Prevention

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

Dietary Supplements in People with Metastatic Cancer Who Are Experiencing Malnutrition, Cachexia, Sarcopenia, and Frailty: A Scoping Review

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