Effect of egg Protein, Omega-3 fatty acids and Vitamin D on Immunonutritional Status and Quality of Life of Breast Cancer Patients undergoing Chemotherapy: A Randomized Control Trial

Abstract

Background: Breast cancer ranked second over all cancers. With increasing numbers of breast cancer patients, the number of younger survivors is growing. Medical treatments such as chemotherapy can negatively interfere with nutritional status. A major player in adequate nutrition is protein. Protein is responsible for building and repairing muscle, tissues, and every cell in human body. It can also help strengthen immune system, making one less susceptible to sickness and infection. Along with the risk factor of breast cancer, it is necessary to find out how- nutritional status, immunity, micronutrient deficiency and quality of life, can be improved to address better disease prognosis. In this study, gold standard egg-protein, omega-3 fatty acid, and Vitamin D were supplemented to the BC chemotherapy patients aiming to improve nutritional status and immunity, thus upgrading QoL and immune-nutritional status. Here, scientific evidence shows a path to oncologist and dietician through improving diet rich in standard protein and Quality of life for the efficacy of drugs. The aim of this study was to assess the effect of breast cancer chemotherapy patients through supplement protein, omega 3 and vitamin D. Materials and Methods: This study, started in December 2019, was a randomized controlled trial (Three-month or 12-weeks follow up) involved breast cancer patients (N=104) undergoing chemotherapy. Participants selected randomly (using a random number generator from the 'calculator.net' website) for both the control (n=52), and intervention groups (n=52). Ethical approvals were obtained from the Ethical Review Committee, Faculty of Biological Sciences, University of Dhaka (Ref. No. 86/Bio. Scs.), and the National Institute of Cancer Research and Hospital, Dhaka (Ref. No. NICRH/Ethics/2020/240). Data collection was carried out through face-to-face interviews using a structured questionnaire. Data were collected at three time points (Baseline, six-weeks later, after the intervention or 12-weeks later), during three-month (or twelve weeks) interventions. Both verbal and written informed consents were obtained from all participants. The intervention group received supplements of 3 eggs (1 whole+ 2 whites), omega-3 fatty xv acids (1 g), and vitamin D (2000 IU) daily for 3-months. Both groups underwent a series of laboratory tests (Albumin, SGPT, SGOT, Creatinine, CRP, CBC, Neutrophil, Eosinophil, and Basophil etc.), and estimation of IgG and CD4 were used to assess immune function, while BMI (Kg/m2), and the Subjective Global Assessment (SGA) scale were used to evaluate nutritional status. Information on physical activity and 24-hour dietary intake were also collected. Quality of life (QoL) was measured for both groups using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ-30 version 3 and EORTC QLQ-BR23). Statistical analysis was conducted using SPSS (version 27) and a significance level of .05. Descriptive statistics, including mean, standard deviation (SD), and percentages were used. At first, normality tests were performed for the data, and for non-normal data, a log10 transformation was applied to normalize the distribution before performing statistical treatment. Homoscedasticity (constant variance), multicoolinearity (tolerance tests) were applied for multivariate tests. Non-parametric ‘Friedman rank test’ was used to compare the case and control groups especially for the laboratory data, and a general linear model (GLM) was used to assess the differences between the two groups across three timelines. Results: The mean age was 44±8.9 years in the intervention group and 44.7±9.3 years in the control group. Baseline BMI was 25.8±4.0 kg/m² in the intervention group (range 19.4-38.2 kg/m²) and 26.4±4.2 kg/m² in the control group (range 18.5-35.5 kg/m²). Patients with advanced-stage, recurrent, or metastatic breast cancer were excluded. Immunohistochemistry revealed that in the intervention and control groups, respectively, the prevalence of breast cancer subtypes was as follows: Luminal A (9.6% vs. 28.8%), Luminal B (7.7% vs. 15.4%), Triple Negative (57.7% vs. 32.7%), and Her2 (25% vs. 23.1%). Subjective Global Assessment (SGA) scores showed significant improvement in the intervention group compared to the control group across three timelines, with a grand mean of 5.24±0.7 for the intervention group and 4.66±0.66 for the control group (p < 0.05). QOL scores were also significantly higher in the intervention group (4.8±0.66) compared to the control group (4.0±0.80) (p < 0.05). xvi BMI showed significant changes over time within both groups, but no significant differences were found between the groups. For albumin, a significance differences within-group effect was observed (F (1,102) =14.67, p < 0.001), though the interaction effect between groups approached significance (F (1,102) =2.9, p = 0.057). Significant within-group and interaction effects were found for SGA scores (F(2,204)=29.36, p < 0.001; F(2,204)=27.39, p < 0.001), Vitamin D (F(1,102)=54.9, p < 0.001; F(1,102)=82.9, p < 0.001), and CD4 levels (F(1,102)=24.9, p < 0.001; F(1,102)=6.57, p = 0.012). IgG showed no significant differences between the groups. Health and QOL both showed significant interaction effects between the intervention and control groups (F (2,204) =101.05, p < 0.001; F (2,204) =91.91, p < 0.001, respectively). In conclusion, the intervention with egg protein, omega-3 fatty acids, and vitamin D supplementation significantly improved nutritional status (BMI Kg/m2, SGA), immune parameters (IgG, CD4), and quality of life (QoL) in breast cancer patients undergoing chemotherapy.