Dataset Information

Nutri-PEITC Jelly Significantly Improves Progression-Free Survival and Quality of Life in Patients with Advanced Oral and Oropharyngeal Cancer: A Blinded Randomized Placebo-Controlled Trial.

ABSTRACT: TP53 mutation is associated with cancer progression. Novel strategies to reboot p53 are required to stabilize the disease and improve survival. This randomized placebo-controlled trial investigated safety and efficacy of Nutri-PEITC Jelly (a texture-modified nutritious diet fortified with β-phenethyl isothiocyanate (PEITC) on oral cancer. Seventy-two patients with advanced-staged oral or oropharyngeal cancer were randomly assigned to study and control groups, who consumed 200 g of Nutri-Jelly with and without 20 mg of PEITC, respectively, 5 days/week for 12 weeks. Outcomes, including adverse events, health-related quality of life (HRQOL), progression-free survival (PFS), tumor response, serum p53, and cytochrome c, were measured at 0, 1, and 3 months. Results show that the study group had a higher proportion of participants with improved HRQOL, stable disease, and increased serum p53 levels than those in the control group (p < 0.001). The PFS time in the study group was significantly longer than that of the control group (p < 0.05). Serum cytochrome c levels were non-significantly decreased in the study group. No serious intervention-related adverse events occurred in either group. In conclusion, Nutri-PEITC Jelly intake for 3 months is safe, stabilizes the disease, improves quality of life and progression-free survival, and might re-activate p53 in advanced-stage oral and oropharyngeal cancer patients.

SUBMITTER: Lam-Ubol A

PROVIDER: S-EPMC10177844 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature

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Nutri-PEITC Jelly Significantly Improves Progression-Free Survival and Quality of Life in Patients with Advanced Oral and Oropharyngeal Cancer: A Blinded Randomized Placebo-Controlled Trial.

Lam-Ubol Aroonwan A Sukhaboon Jirasak J Rasio Withee W Tupwongse Peerawitch P Tangshewinsirikul Thapana T Trachootham Dunyaporn D

International journal of molecular sciences 20230425 9

<i>TP53</i> mutation is associated with cancer progression. Novel strategies to reboot p53 are required to stabilize the disease and improve survival. This randomized placebo-controlled trial investigated safety and efficacy of Nutri-PEITC Jelly (a texture-modified nutritious diet fortified with β-phenethyl isothiocyanate (PEITC) on oral cancer. Seventy-two patients with advanced-staged oral or oropharyngeal cancer were randomly assigned to study and control groups, who consumed 200 g of Nutri-J ...[more]

PMID: 37175527

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Project description:Intestinal bacteria may influence lung homeostasis via the gut-lung axis. We conducted a single-center, quadruple-blinded, randomized trial in adult symptomatic Coronavirus Disease 2019 (Covid19) outpatients. Subjects were allocated 1:1 to probiotic formula (strains Lactiplantibacillus plantarum KABP022, KABP023, and KAPB033, plus strain Pediococcus acidilactici KABP021, totaling 2 × 109 colony-forming units (CFU)) or placebo, for 30 days. Co-primary endpoints included: i) proportion of patients in complete symptomatic and viral remission; ii) proportion progressing to moderate or severe disease with hospitalization, or death; and iii) days on Intensive Care Unit (ICU). Three hundred subjects were randomized (median age 37.0 years [range 18 to 60], 161 [53.7%] women, 126 [42.0%] having known metabolic risk factors), and 293 completed the study (97.7%). Complete remission was achieved by 78 of 147 (53.1%) in probiotic group compared to 41 of 146 (28.1%) in placebo (RR: 1.89 [95 CI 1.40-2.55]; P < .001), significant after multiplicity correction. No hospitalizations or deaths occurred during the study, precluding the assessment of remaining co-primary outcomes. Probiotic supplementation was well-tolerated and reduced nasopharyngeal viral load, lung infiltrates and duration of both digestive and non-digestive symptoms, compared to placebo. No significant compositional changes were detected in fecal microbiota between probiotic and placebo, but probiotic supplementation significantly increased specific IgM and IgG against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV2) compared to placebo. It is thus hypothesized this probiotic primarily acts by interacting with the host's immune system rather than changing colonic microbiota composition. Future studies should replicate these findings and elucidate its mechanism of action (Registration: NCT04517422).Abbreviations: AE: Adverse Event; BMI: Body Mass Index; CONSORT: CONsolidated Standards of Reporting Trials; CFU: Colony-Forming Units; eDRF: Electronic Daily Report Form; GLA: Gut-Lung Axis; GSRS: Gastrointestinal Symptoms Rating Scale; hsCRP: High-sensitivity C-Reactive Protein; HR: Hazard Ratio; ICU: Intensive Care Unit; OR: Odds Ratio; PCoA: Principal Coordinate Analysis; RR: Relative Risk; RT-qPCR: Real-Time Quantitative Polymerase Chain Reaction; SARS-CoV2: Severe acute respiratory syndrome coronavirus 2; SpO2: Peripheral Oxygen Saturation; WHO: World Health Organization.

Project description:BackgroundPrevious studies have shown that dexamethasone has a positive effect on postoperative pain control, opioid consumption, nausea, and vomiting and length of hospital stay after arthroplasty surgery.Purpose/hypothesisThe purpose of this study was to assess whether adding perioperative dexamethasone to our current pain regimen after hip arthroscopy is more effective than a placebo. It was hypothesized that dexamethasone would reduce postoperative pain, reduce opioid consumption, improve subjective pain and nausea scores, and reduce the number of vomiting events.Study designRandomized controlled trial; Level of evidence, 1.MethodsA total of 50 patients requiring unilateral elective hip arthroscopy were randomized to receive intravenous dexamethasone immediately before induction of anesthesia and at 8 am on the first postoperative day (2 ×12 mg) or a placebo (sodium chloride 0.9%). The patient, the surgeons, the treating anesthesiologist, and the involved nursing and physical therapy personnel were blinded to group assignment. The primary outcome was postoperative pain, and secondary outcomes were opioid consumption and nausea scores-assessed using a translated revised version of the American Pain Society Patient Outcome Questionnaire 6 hours postoperatively and on days 1 and 2-and vomiting events. A clinical follow-up was performed 12 weeks postoperatively to assess adverse events.ResultsThe mean age at inclusion was 29 years in both groups. Postoperative pain levels did not differ significantly in most instances. Opioid requirements during the hospitalization in the dexamethasone group were significantly lower than those in the placebo group (31.96 ± 20.56 mg vs 51.43 ± 38 mg; P = .014). Significantly fewer vomiting events were noted in the dexamethasone group (0.15 ± 0.59 vs 0.65 ± 0.91; P = .034). Descriptive data and surgical parameters did not differ significantly.ConclusionPerioperative intravenous dexamethasone significantly reduced postoperative opioid consumption by 40% without compromising pain level and safety, as no corticosteroid-related side effects were observed. Dexamethasone may be a valuable adjuvant to a multimodal systemic pain regimen after hip arthroscopy.RegistrationNCT04610398 (ClinicalTrials.gov identifier).

Dataset Information

Nutri-PEITC Jelly Significantly Improves Progression-Free Survival and Quality of Life in Patients with Advanced Oral and Oropharyngeal Cancer: A Blinded Randomized Placebo-Controlled Trial.

Publications

Nutri-PEITC Jelly Significantly Improves Progression-Free Survival and Quality of Life in Patients with Advanced Oral and Oropharyngeal Cancer: A Blinded Randomized Placebo-Controlled Trial.

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