The effects of a family-centered psychosocial-based nutrition intervention in patients with advanced cancer: the PiCNIC2 pilot randomised controlled trial

BACKGROUND: Malnutrition in advanced cancer patients is common but limited and inconclusive data exists on the effectiveness of nutrition interventions. Feasibility and acceptability of a novel family-based nutritional psychosocial intervention were established recently. The aims of this present study were to assess the feasibility of undertaking a randomised controlled trial of the latter intervention, to pilot test outcome measures and to explore preliminary outcomes.METHODS: Pilot randomised controlled trial recruiting advanced cancer patients and family caregivers in Australia and Hong Kong. Participants were randomised and assigned to one of two groups, either a family-centered nutritional intervention or the control group receiving usual care only. The intervention provided 2-3 h of direct dietitian contact time with patients and family members over a 4-6-week period. During the intervention, issues with nutrition impact symptoms and food or eating-related psychosocial concerns were addressed through nutrition counselling, with a focus on improving nutrition-related communication between the dyads and setting nutritional goals. Feasibility assessment included recruitment, consent rate, retention rate, and acceptability of assessment tools. Validated nutritional and quality of life self-reported measures were used to collect patient and caregiver outcome data, including the 3-day food diary, the Patient-Generated Subjective Global Assessment Short Form, the Functional Assessment Anorexia/Cachexia scale, Eating-related Distress or Enjoyment, and measures of self-efficacy, carers' distress, anxiety and depression.RESULTS: Seventy-four patients and 54 family caregivers participated in the study. Recruitment was challenging, and for every patient agreeing to participate, 14-31 patients had to be screened. The consent rate was 44% in patients and 55% in caregivers. Only half the participants completed the trial's final assessment. The data showed promise for some patient outcomes in the intervention group, particularly with improvements in eating-related distress (p = 0.046 in the Australian data; p = 0.07 in the Hong Kong data), eating-related enjoyment (p = 0.024, Hong Kong data) and quality of life (p = 0.045, Australian data). Energy and protein intake also increased in a clinically meaningful way. Caregiver data on eating-related distress, anxiety, depression and caregiving burden, however, showed little or no change.CONCLUSIONS: Despite challenges with participant recruitment, the intervention demonstrates good potential to have positive effects on patients' nutritional status and eating-related distress. The results of this trial warrant a larger and fully-powered trial to ascertain the effectiveness of this intervention.TRIAL REGISTRATION: The trial was registered with the Australian &amp; New Zealand Clinical Trials Registry, registration number ACTRN12618001352291 .</p

Adverse events following immunization and psychological distress among cancer patients/survivors following vaccination against SARS-CoV-2 infection

PurposeThis study aims to describe the adverse events following immunization (AEFIs) of SARS-CoV-2 vaccination in cancer patients/survivors associated with their psychological distress.MethodsA cross-sectional study was conducted to assess AEFIs after the receipt of SARS-CoV-2 vaccines in cancer patients/survivors attending a university hospital in Malaysia. Psychological distress was measured using the Hospital Anxiety and Depression Scale (HADS) before and after the first and second doses of COVID-19 vaccine.ResultsA total of 217 complete responses were received. Compared with before vaccination, both HADS Anxiety (HADS-A) and HADS Depression (HADS-D) scores were significantly reduced after the first and second dose of the SARS-CoV-2 vaccine. Most of the participants had mild-or-moderate systemic and local AEFIs, with the most common being pain at the injection site, tiredness, and headache for both the first and second doses of the vaccine. Positive correlations between the total AEFI score and HADS-A (r = 0.309, p &lt; 0.001) and HADS-D (r = 0.214, p = 0.001) scores were observed after the first dose of the SARS-CoV-2 vaccine. Similarly, positive associations were observed between the total AEFI score and HADS-A (r = 0.305, p &lt; 0.001) and HADS-D (r = 0.235, p &lt; 0.001) scores after the second dose of the SARS-CoV-2 vaccine.ConclusionMild-to-moderate AEFIs found in this study help address vaccine hesitancy in cancer patients/survivors. Receiving the SARS-CoV-2 vaccine had a positive effect on decreasing psychological distress in cancer patients/survivors. High severity of an AEFI was associated with higher anxiety and depressive symptoms

The impact of epilepsy and antiseizure medications on pregnancy and neonatal outcomes: A nationwide cohort study

Abstract Purpose Our objective was to assess the adverse outcomes during pregnancy, as well as for the fetus and neonates, in women with epilepsy, both with and without the use of antiseizure medications (ASMs). Methods A cohort of singleton pregnancies between January 1, 2004 and December 31, 2014 was identified using the Taiwan National Health Database. The pregnancies were categorized into ASM exposure, ASM nonexposure, and control (consisting of women without an epilepsy diagnosis) groups. We recorded adverse outcomes in neonates and documented pregnancy complications. The generalized estimating equation with logit link was used to estimate adjusted odds ratios. Results There were 629 singleton pregnancies in the group exposed to ASMs, 771 in the epilepsy group without ASM exposure, and 2,004,479 in the control group. Women with epilepsy had a significantly higher risk of puerperal cerebrovascular diseases (adjusted odds ratios in the exposure and nonexposure groups = 54.46 and 20.37, respectively), respiratory distress syndrome (5.1 and 2.99), mortality (3.15 and 3.22), sepsis (2.67 and 2.54), pregnancy‐related hypertension (1.71 and 1.8), preeclampsia (1.87 and 1.79), cesarean delivery (1.72 and 2.15), and preterm labor (1.38 and 1.56). The use of ASMs may increase the risk of eclampsia (adjusted odds ratio = 12.27). Compared to controls, fetuses/neonates born to women with epilepsy had a higher risk of unexplained stillbirth (adjusted odds ratios in the exposure and nonexposure groups = 2.51 and 2.37, respectively), congenital anomaly (1.37 and 1.33), central nervous system malformation (3.57 and 2.25), low birth weight (1.90 and 1.97), and a low Apgar score at 5 min (2.63 and 1.3). The use of ASMs may introduce an additional risk of small for gestational age; the adjusted odds ratio was 1.51. Conclusion Women with epilepsy, irrespective of their exposure to ASMs, had a slightly elevated risk of pregnancy and perinatal complications. Puerperal cerebrovascular diseases may be a hidden risk for women with epilepsy

Regulation of G₂/M cell cycle DNA damage checkpoints

Deregulation of the cell cycle checkpoints is a key step in tumorigenesis. we present evidence that apart from CDC25, WEE1 may also be important for the G₂/M DNA damage checkpoints. ING1 is a candidate tumor suppressor that cooperates with p53 to inhibit cell proliferation. We show that ING1 can regulate the cell cycle and the DNA damage responses at G₂/M phase independent of p53 functions. ING1b enhanced the p53-independent G₂/M DNA damage checkpoint induced by adriamycin, but did not affect the G₁ DNA damage checkpoint. No significant transactivation of p21^CIP1/WAF1 and MDM2 by ING1 in the absence of p53 was observed, suggesting that mechanisms involving activation of p53-related proteins are unlikely to contribute to the G₂/M cell cycle arrest caused by ING1b. These data provide evidence of the involvement of WEE1 and ING1 in the G₂/M DNA damage checkpoint. Understanding precisely how these proteins regulate the cell cycle and checkpoints may shed light on the mechanism of tumorigenesis