The goal of this clinical trial is to test the effect of the administration of APPORTAL® in addition to the SoC (recommended physical exercise), in patients with breast cancer, suffering from fatigue during neoadjuvant and adjuvant chemotherapy. The main questions it aims to answer are:
* if the food supplement APPORTAL® can be of help in supporting the physiological energy level, against the fatigue symptom in cancer patients undergoing adjuvant chemotherapy; * if the supplementation with APPORTAL® can optimize the nutritional status, the muscular strength, the quality of life of the patient.
Also, the patients' satisfaction on the product received, the adherence to treatment will be evaluated and the overall safety and tolerability of the study product.
The patients will be asked to perform 3 study visits from baseline to the end of treatment (at 4 and 8 weeks after baseline) and a follow-up visit after 12 weeks from baseline.
The main assessments at each visit will be:
* physical examination, weight, Body Mass Index (BMI), body temperature (°C), heart rate, respiratory frequency, and systolic and diastolic blood pressure; * previous and concomitant treatments; * fatigue assessment through BFI questionnaire; * quality of life through questionnaire SF-12; * muscular strength (dynamometer) * Adverse Event check (from Visit 2) Moreover, at visit 1 (baseline) and at visit 3 (end of treatment) a blood sample will be collected to evaluate the blood metabolites.
Telephonic follow-up will be done at 2 weeks, 6 weeks, 10 weeks to assess compliance and to recommendations on physical activity and to study treatment (only at 2 and 6 weeks) and tolerability/safety.
Participants will receive the nutrition supplement or the placebo, in addition to the SoC (recommended physical exercise), for 8 weeks.
Researchers will compare Apportal® and Placebo groups to see if the physiological energy level against the fatigue symptom, the nutritional status, the muscular strength, the quality of life of the patient improve after 8 weeks of treatment with APPORTAL® in addition to SoC (recommended physical exercise).
Females aged 18 or higher.
Patients diagnosed with histologically confirmed breast cancer.
Patients having done at least one cycle of neoadjuvant or adjuvant chemotherapy (independently from type of chemotherapy) and who are on active chemotherapy treatment throughout the duration of the study (*).
Patients with ECOG performance status ≤1 at screening.
Women who are pregnant or breast-feeding.
Neoplastic disease other than primary breast cancer.
Had major surgery other than breast cancer surgery (central venous access placement and tumor biopsies are not considered major surgery) within 4 weeks prior to randomization. Patients must be well recovered from acute effects of surgery prior to screening. Patients should not have plans to undergo major surgical procedures during the treatment period.
Patients with known or symptomatic metastases.
Parallel
APPOPRTAL®
Dietary supplement1 sachet of APPORTAL® contains: Vitamin C 37,5 mg; Vitamin E 30 mg; Vitamin PP 18 mg; Vitamin B1 1 mg; Vitamin D 25 μg; Vitamin H 25 μg; L-arginine 1000 mg; L-carnitine 500 mg; Taurine 25 mg; Ginseng e.s. 100 mg; Eleutherococcus e.s. 50 mg; Magnesium 187,5 mg; Iron 14 mg; Zinc 1,5 mg; Iodine 75 μg; Selenium 27,5 μg; Coenzyme Q10 100 mg; Lycopene 3,06 mg; Tocotrienols 2,5 mg; Coenzyme Q10 100 mg; Lycopene 3,06 mg; Tocotrienols 2,5 mg
Placebo
Other interventionIngredients: Maltodextrin, acidifying agent: citric acid, flavours, anticaking agent: tricalcium phosphate, beetroot juice powder; sweetener: sucralose, anti-caking agent: silicon dioxide, colouring agent: beta-carotene
The change of fatigue perception by the patient through the BFI questionnaire
The Brief Fatigue Inventory (BFI) is a questionnaire specifically developed for rapid assessment of CRF. It is a simple, easily administered questionnaire and the fatigue scale (validated in different languages) consists in nine items anticipated by a flag question asking the patient whether she has felt unusually fatigued or tired during the last week. Three items are related to the intensity of fatigue "right now", at its "usual" level and at its "worst" level during the past 24 h using a 0-10 numerical scale (0= no fatigue, 10= fatigue as bad as you can image). Six items measure the interference of fatigue with the patients' life during the past 24 h by a 0-10 numerical scale (0= does not interfere, 10= completely interferes). Higher scores represent to more severe fatigue
The change of fatigue perception by the patient through the BFI questionnaire
The Brief Fatigue Inventory (BFI) is a questionnaire specifically developed for rapid assessment of CRF. It is a simple, easily administered questionnaire and the fatigue scale (validated in different languages) consists in nine items anticipated by a flag question asking the patient whether she has felt unusually fatigued or tired during the last week. Three items are related to the intensity of fatigue "right now", at its "usual" level and at its "worst" level during the past 24 h using a 0-10 numerical scale (0= no fatigue, 10= fatigue as bad as you can image). Six items measure the interference of fatigue with the patients' life during the past 24 h by a 0-10 numerical scale (0= does not interfere, 10= completely interferes). Higher scores represent to more severe fatigue
Change in Iron status through hemoglobin assessment
Blood samples of about 5 mL will be collected for the assessment of iron status (hemoglobin, ferritin, transferrin saturation), nutritional markers (albumin, total cholesterol, HDL, LDL and triglycerides), oxidative markers (homocysteine, uric acid) and C-Reactive Protein, serum L-arginine levels. Blood samples will be analysed locally by each site laboratory.
Change in Iron status through ferritin assessment
Blood samples of about 5 mL will be collected for the assessment of iron status (hemoglobin, ferritin, transferrin saturation), nutritional markers (albumin, total cholesterol, HDL, LDL and triglycerides), oxidative markers (homocysteine, uric acid) and C-Reactive Protein, serum L-arginine levels. Blood samples will be analysed locally by each site laboratory.
Change in Iron status through transferrin saturation assessment
Blood samples of about 5 mL will be collected for the assessment of iron status (hemoglobin, ferritin, transferrin saturation), nutritional markers (albumin, total cholesterol, HDL, LDL and triglycerides), oxidative markers (homocysteine, uric acid) and C-Reactive Protein, serum L-arginine levels. Blood samples will be analysed locally by each site laboratory.
Study product tolerability
Study product tolerability will be assessed by number of adverse events related to the product
Change in Physical Examination through weight measurement
Weight (Kg)
Change in Physical Examination through BMI evaluation
BMI (Kg/m\^2)
Change in Physical Examinations through clinical evaluation by system
Number of normal/abnormal conditions per system
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Pharmanutra S.p.a.
Lead sponsor
Latis S.r.l.
Collaborator
