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Clinical Impact of Highly Purified, Whey Proteins in Patients Affected With Colorectal Cancer Undergoing Chemotherapy: Preliminary Results of a Placebo-Controlled Study.

ABSTRACT: Background and Aims: Sarcopenia, the loss of both lean body and skeletal muscle mass, may interfere in cancer patients outcome. As investigated, whey proteins could prevent the onset of sarcopenia. We have conducted a study to evaluate the effects of whey protein in colorectal cancer patients, undergoing 5-fluorouracil-based chemotherapy. Methods: After written informed consent, patients were blind randomized 1:1 to whey protein (ProLYOtin; arm A) versus placebo (arm B). The patients were assessed both physically and nutritionally before chemotherapy and after 3 (T2) and 6 months (T3) by body impedance assessment, L3-computed tomography scan, Mini Nutritional Assessment (MNA), and Malnutrition Universal Screening Tool (MUST) tests. Results: Forty-seven patients were included in this preliminary analysis. Baseline characteristics were well balanced between the 2 arms. During chemotherapy, 33 patients were reevaluated: anthropometric parameters (lean body mass from 68.5% to 71.2% vs 68.7% to 66.3%, and sarcopenia from 84% to 54% and 83% to 77% from baseline to T2 evaluation in arms A and B, respectively), nutritional status (MNA >24 = 100% [A] vs 73.7% [B]), and toxicity (no adverse effects in 86% [A] vs 29% [B] and 94% [A] vs 29% [B] for hematological and gastrointestinal toxicities, respectively) resulted to be significantly different. At univariate analysis, a condition of malnutrition risk according to MUST (relative risk [RR] = 7.5, P = .02) or MNA (RR = 1.45, P = .02) and ProLYOtin intake (RR = 0.12, P = .01) were found to be significantly predictive of chemotherapy toxicity. Conclusions: At present, our study shows how whey protein could be an important therapeutic option to improve nutritional status, and particularly to prevent severe toxicity during chemotherapy.

SUBMITTER: Mazzuca F

PROVIDER: S-EPMC6681246 | biostudies-literature | 2019 Jan-Dec

REPOSITORIES: biostudies-literature

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Clinical Impact of Highly Purified, Whey Proteins in Patients Affected With Colorectal Cancer Undergoing Chemotherapy: Preliminary Results of a Placebo-Controlled Study.

Mazzuca Federica F Roberto Michela M Arrivi Giulia G Sarfati Elena E Schipilliti Francesca Matilde FM Crimini Edoardo E Botticelli Andrea A Di Girolamo Marco M Muscaritoli Maurizio M Marchetti Paolo P

Integrative cancer therapies 20190101

<b>Background and Aims:</b> Sarcopenia, the loss of both lean body and skeletal muscle mass, may interfere in cancer patients outcome. As investigated, whey proteins could prevent the onset of sarcopenia. We have conducted a study to evaluate the effects of whey protein in colorectal cancer patients, undergoing 5-fluorouracil-based chemotherapy. <b>Methods:</b> After written informed consent, patients were blind randomized 1:1 to whey protein (ProLYOtin; arm A) versus placebo (arm B). The patien ...[more]

PMID: 31370717

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Project description:BackgroundA safe, effective, and rapidly scalable vaccine against Zika virus infection is needed. We developed a purified formalin-inactivated Zika virus vaccine (ZPIV) candidate that showed protection in mice and non-human primates against viraemia after Zika virus challenge. Here we present the preliminary results in human beings.MethodsWe did three phase 1, placebo-controlled, double-blind trials of ZPIV with aluminium hydroxide adjuvant. In all three studies, healthy adults were randomly assigned by a computer-generated list to receive 5 μg ZPIV or saline placebo, in a ratio of 4:1 at Walter Reed Army Institute of Research, Silver Spring, MD, USA, or of 5:1 at Saint Louis University, Saint Louis, MO, USA, and Beth Israel Deaconess Medical Center, Boston, MA, USA. Vaccinations were given intramuscularly on days 1 and 29. The primary objective was safety and immunogenicity of the ZPIV candidate. We recorded adverse events and Zika virus envelope microneutralisation titres up to day 57. These trials are registered at ClinicalTrials.gov, numbers NCT02963909, NCT02952833, and NCT02937233.FindingsWe enrolled 68 participants between Nov 7, 2016, and Jan 25, 2017. One was excluded and 67 participants received two injections of Zika vaccine (n=55) or placebo (n=12). The vaccine caused only mild to moderate adverse events. The most frequent local effects were pain (n=40 [60%]) or tenderness (n=32 [47%]) at the injection site, and the most frequent systemic reactogenic events were fatigue (29 [43%]), headache (26 [39%]), and malaise (15 [22%]). By day 57, 52 (92%) of vaccine recipients had seroconverted (microneutralisation titre ≥1:10), with peak geometric mean titres seen at day 43 and exceeding protective thresholds seen in animal studies.InterpretationThe ZPIV candidate was well tolerated and elicited robust neutralising antibody titres in healthy adults.FundingDepartments of the Army and Defense and National Institute of Allergy and Infectious Diseases.

Project description:ObjectiveThis study aimed to explore the effects of our rational emotive behavior therapy (REBT) program on symptoms, anxiety, depression, and sleep state in patients with colorectal cancer (CRC) undergoing chemotherapy.MethodsFrom October 2020 to May 2021, fifty-six patients with CRC in a hospital in the Hunan Province were randomly divided into an intervention group (n = 28) and a control group (n = 28). The patients in the intervention group completed a 6-week REBT program based on routine nursing care, including four courses: 1) establish a relationship and formulate health files; 2) group communications and study symptom management; 3) continuously provide health knowledge and strengthen healthy behavior; and 4) review the treatment and summary. The control group maintained routine nursing care. The simplified Chinese version of the Memorial Symptom Assessment Scale Short Form (MSAS-SF-SC), the Hospital Anxiety and Depression Scale (HADS), and the Pittsburgh Sleep Quality Index (PSQI) scale were used to investigate and compare the intervention effects of the two groups at baseline (T1, before the intervention), four weeks (T2), and six weeks (T3) after the intervention.ResultsThe intervention group was significantly improved in symptoms, anxiety, depression, and sleep state, compared with the control group. At T2, MSAS-SF-SC (24.43 ± 4.26 vs.28.07 ± 3.91), symptom distress (17.29 ± 4.04 vs. 19.39 ± 3.59), symptom frequency (7.14 ± 1.51 vs. 8.68 ± 1.42), HADS (13.68 ± 3.38 vs. 15.86 ± 3.79), anxiety (3.89 ± 1.85 vs. 5.18 ± 2.18), and depression (9.79 ± 2.06 vs. 10.68 ± 2.23), showed that the difference between the two groups was statistically significant (P < 0.05). At T3, MSAS-SF-SC (23.89 ± 3.54 vs. 30.14 ± 3.94), symptom distress (17.61 ± 3.52 vs. 21.32 ± 3.57), symptom frequency (6.29 ± 1.49 vs. 8.82 ± 1.47), HADS (11.82 ± 2.57 vs. 16.29 ± 3.13), anxiety (3.21 ± 1.64 vs. 5.61 ± 1.77), and depression (8.61 ± 1.52 vs. 10.68 ± 1.81), showed that the difference between the two groups was statistically significant (P < 0.05). The sleep state of the intervention group was better than the control group at T3, with decreased score of PSQI [4.00 (3.00,8.00) vs. 9.00 (7.00,12.50), Z = -3.706, P < 0.001].ConclusionThe 6-week REBT program can effectively improve the symptom, anxiety, depression, and sleep state of patients with CRC undergoing chemotherapy, which could as a care plan for patients with CRC who are repeatedly admitted to the hospital for chemotherapy.

Dataset Information

Clinical Impact of Highly Purified, Whey Proteins in Patients Affected With Colorectal Cancer Undergoing Chemotherapy: Preliminary Results of a Placebo-Controlled Study.

Publications

Clinical Impact of Highly Purified, Whey Proteins in Patients Affected With Colorectal Cancer Undergoing Chemotherapy: Preliminary Results of a Placebo-Controlled Study.

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