Abstract P2-12-16: A PROSPECTIVE RANDOMIZED PLACEBO-CONTROLLED TRIAL EVALUATING EFFECT OF A WIDE SPECTRUM MICRONUTRIENTS SUPPLEMENT ON CANCER RELATED FATIGUE IN BREAST CANCER PATIENTS TREATED WITH ADJUVANT/NEO-ADJUVANT THERAPY

Abstract Background: Fatigue is the most common symptom experienced by patients during the cancer trajectory from diagnosis to the end of life. Several studies in breast cancer (BC) patients confirm that fatigue is the most reported symptom (88-91%). Women with BC are the highest users of complementary therapies, including use of micronutrients, to prevent or reduce the Cancer-related fatigue (CRF) severity. This highlights how there is still today the need for non-pharmacological treatments that are able to relieve CRF in breast cancer (BC) patients. There is no unanimous consensus on the use of micronutrients in CRF and randomized controlled studies are needed to define the effect of these substances. Recently a nutritional supplement containing 19 nutrients including amino acids such as arginine and carnitine, highly absorbed minerals such as Sucrosomial® iron, magnesium, zinc and selenium, group B vitamins, and plant extracts as Panax ginseng and Eleutherococcus senticosus (Apportal®) demonstrated a significantly improvement of post-Covid related fatigue and to ameliorate muscle strength and physical performance in subject suffering from long-Covid syndrome. Besides, a recent cohort study including 458 individuals who reported fatigue from different causes (not Covid related) showed that the intake of APPORTAL® significantly improves both mental and physical fatigue (under submission). Study Objectives: The primary objective of this study is to investigate if BC patients undergoing adjuvant or neo-adjuvant therapy can have a beneficial effect from Apportal® supplementation. Secondary objectives are evaluating if the supplementation with APPORTAL® can improve patients’ nutritional status, muscular strength, and quality of life (QoL). Trial design: This is a randomized, placebo controlled, multicenter study with two parallel groups of patients. Patients with BC, suffering from fatigue after at least one cycle of adjuvant or neo-adjuvant chemotherapy will receive APPORTAL®, (Pharmanutra SpA, Italy), 1 sachet per day or placebo for 8 weeks. Visits were scheduled at baseline and after 4-8-12 weeks, assessing fatigue (BFI questionnaire), physical status, blood nutritional markers, quality of life (QoL), muscular strengths, compliance and adverse events. Major Inclusion Criteria: - Females aged 18 or higher - Patients diagnosed with histologically confirmed BC - Patients having done at least one cycle of adjuvant or neo-adjuvant chemotherapy - ECOG performance status ≤1 at screening - CRF of moderate-severe intensity (NRS > 4) - Patients able to follow the recommendations on the physical exercise to do - Patients who accept to use adequate contraceptive methods, if they are of child-bearing potential. Sample Size 92 patients randomized 1:1 ratio into Treatment group (APPORTAL® plus physical exercise) and Placebo group (Placebo plus physical exercise). Estimated Dates for Completing Accrual Patient recruitment will be completed by mid-2025. First patient was enrolled in December 2023. Trial Registration Number NCT 06137833 Citation Format: Alessandra Fabi, Luisa Carbognin, Silvia Rotondaro, Stefania Russo, Giulia De Pieri, Andrea Fontana, Sara Donati, Carmelo Bengala, Laura Velutti, Rebecca Pedersini, Andrea Antonuzzo, Paolo Bossi, Maria Sole Rossato, Germano Tarantino. A PROSPECTIVE RANDOMIZED PLACEBO-CONTROLLED TRIAL EVALUATING EFFECT OF A WIDE SPECTRUM MICRONUTRIENTS SUPPLEMENT ON CANCER RELATED FATIGUE IN BREAST CANCER PATIENTS TREATED WITH ADJUVANT/NEO-ADJUVANT THERAPY [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2024; 2024 Dec 10-13; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2025;31(12 Suppl):Abstract nr P2-12-16.