A prospective study to evaluate the efficacy and safety of vitamin E and levocarnitine prophylaxis against doxorubicin-induced cardiotoxicity in adult breast cancer patients.

BACKGROUND: Doxorubicin induces acute and chronic cardiotoxicity. This study is aimed to evaluate the efficacy and safety of vitamin E and levocarnitine (EL) as cardioprotective agents against acute doxorubicin cardiotoxicity in female adult breast cancer patients. METHODS: A prospective, randomized controlled study was conducted in patients treated with doxorubicin and cyclophosphamide (AC). Patients were randomly assigned to EL plus AC or AC alone for the duration of 4 cycles. Cardiac enzymes (B-type natriuretic peptide, creatine kinase, troponin I (Trop)) and cardiac events were monitored during treatment to evaluate the cardioprotective efficacy of EL. RESULTS: Seventy-four patients were recruited and received four cycles of chemotherapy. The intervention group (n = 35) showed a significant reduction in both the B-type natriuretic peptide and creatine kinase cardiac enzymes compared to the control group (n = 39). The median (IQR) change for BNP was 0.80 (0.00-4.00) for IG versus 1.80 (0.40-3.60) for CG groups (p < 0.001); creatine kinase was -0.08 (-0.25-0.05) for IG versus 0.20 (0.05-0.50) for CG (p < 0.001). The addition of EL decreased the cardiac events by 24.2% (p = 0.02). All adverse events were tolerable and manageable. CONCLUSION: This study supports the addition of EL as prophylaxis against acute doxorubicin cardiotoxicity and it was also very well tolerated by a majority of the patients. The co-administration of EL at higher doxorubicin (240 mg/m2) dose should be further investigated.

Quality of Life and Psychological Wellbeing of Breast Cancer Survivors in the Kingdom of Saudi Arabia.

INTRODUCTION: Breast cancer is the most common cancer among Saudi population. Breast cancer patients suffer from several negative consequences after treatment and these include pain, fatigue, sexual problems, appearance and body image concerns, with psychological dysfunction. This could affect the patient quality of life and psychological well-being. METHODS: a multicenter cross-sectional study to assess quality of life and psychological wellbeing and their predictors for female breast cancers survivors diagnosed between 1 January 2015 and May 2017 with the assessment conducted at 12 to 36 months after initial diagnosis. Assessment was performed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), the Breast Module (QLQ-BR23) and the Hospital Anxiety and Depression Scale (HADS). RESULTS: 246 Breast cancer patients participated in the study with a mean age of 49.5±10.9. The mean global health status has a mean of 72.7±23.5. The worst domain of the functioning scales was physical functioning (mean score of 62.14±26.03, while the best scores were for social functioning of 80.06±29.18. For the symptom scales, the worst scores were reported for fatigue and pain. Results of HADS scale showed that 57% had moderate to severe depression, while 44% had moderate to severe anxiety. Only 6.8% of the participants reported receiving psychosocial support. DISCUSSION: Breast cancer survivors in the KSA have overall good quality of life scores when compared with patients from Western countries. However, their psychological wellbeing is more impaired. There is an urgent need for psychosocial support programs and psychological screening and consultation for breast cancer patients at cancer care centers in the KSA.

Quality of Life and Psychological Wellbeing of Colorectal Cancer Survivors in the KSA.

INTRODUCTION: Colorectal cancer (CRC) ranked first among cancers reported in males and ranked third amongst females in Saudi Arabia. CRC cancer symptoms or symptoms secondary to treatment, such as diarrhea, constipation, fatigue and loss of appetite are very common and has significant negative effects on the quality of life (QoL). METHODS: This project was a cross-sectional study of colorectal cancer survivors diagnosed between 1 January 2015 and May 2017. Assessment was performed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), the colorectal cancer specific module (EORTC QLQ-CR 29) and the Hospital Anxiety and Depression Scale (HADS). Data on potential predictors of scores were also collected. RESULTS: 115 CRC patients from Middle, Eastern and Western regions of the KSA participated in the study. Participants have unexpectedly low global health score with a mean of 56.9±31.3. Physical functioning scale had the lowest score of 61.3±27.7. Regarding the generic symptoms of cancer, fatigue was the worst symptom, followed by appetite loss. Psychological wellbeing assessment utilizing HADS reveals alarming outcomes for survivors of CRC in the KSA with high proportion of participants with moderate to severe depression (55%) and a good proportion of participants with moderate to high anxiety (31%). Only 3.7% of participants reported receiving psychosocial support. DISCUSSION: Results of this project reveal an overall trend of low scores of quality of life amongst colorectal cancer patients in the KSA when compared with regional or international figures. Consistent results for psychological wellbeing were reached. We recommend routine screening for quality of life and psychological wellbeing and including the outcomes per individual patient care. Psychological support is highly needed for cancer survivors.

Electronic early notification of sepsis in hospitalized ward patients: a study protocol for a stepped-wedge cluster randomized controlled trial.

BACKGROUND: To evaluate the effect of screening for sepsis using an electronic sepsis alert vs. no alert in hospitalized ward patients on 90-day in-hospital mortality. METHODS: The SCREEN trial is designed as a stepped-wedge cluster randomized controlled trial. Hospital wards (total of 45 wards, constituting clusters in this design) are randomized to have active alert vs. masked alert, 5 wards at a time, with each 5 wards constituting a sequence. The study consists of ten 2-month periods with a phased introduction of the intervention. In the first period, all wards have a masked alert for 2 months. Afterwards the intervention (alert system) is implemented in a new sequence every 2-month period until the intervention is implemented in all sequences. The intervention includes the implementation of an electronic alert system developed in the hospital electronic medical records based on the quick sequential organ failure assessment (qSOFA). The alert system sends notifications of "possible sepsis alert" to the bedside nurse, charge nurse, and primary medical team and requires an acknowledgment in the health information system from the bedside nurse and physician. The calculated sample size is 65,250. The primary endpoint is in-hospital mortality by 90 days. DISCUSSION: The trial started on October 1, 2019, and is expected to complete patient follow-up by the end of October 2021. TRIAL REGISTRATION: ClinicalTrials.gov NCT04078594 . Registered on September 6, 2019.

Obesity, gestational weight gain, and polyunsaturated fatty acids profile in pregnant Saudi women.

Obesity and excessive gestational weight gain (GWG) are associated with a deficiency of essential fatty acids, affecting maternal health during and after pregnancy. Therefore, it is of interest to identify the associations of pre-pregnancy body mass index (BMI) and GWG with lipid profiles in Saudi women after giving birth. Hence, a cross-sectional study of 238 pregnant women aged 20-40 years was conducted at the King Abdul Aziz Hospital, in Al-Ahsa Governorate-Saudi Arabia. Thus, socio-demographic and anthropometric data were collected using a structured questionnaire. Poly-unsaturated fatty acids (PUFAs), saturated fatty acids (SFAs), and monounsaturated fatty acids (MUFAs) levels were assessed from blood samples collected after the women gave birth. The participants generally consumed diets low in omega-3 and omega-6 PUFAs and high in SFAs and MUFAs. Among them, 51% had university degrees, only 20.4% were employed, and 50% had pre-pregnancy overweight/obesity. Women with overweight/obesity had a higher omega-6 to omega-3 PUFA ratio than women with normal weight. Overweight, obesity, and excessive GWG were not associated with higher levels of total n-3 PUFAs, docosahexaenoic acid, and α-linolenic acid but were associated with higher levels of total n-6 PUFAs and linoleic acid. Women with obesity had significantly higher SFA and MUFA levels than women with normal weight, whereas women with excessive GWG were twice as likely to have higher SFA levels than women with adequate GWG. We show that a higher pre-pregnancy BMI and excessive GWG were significantly associated with abnormal lipid profiles in Saudi women after giving birth. We believe that future studies will help explore these associations in detail.