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.
Pharmanutra S.p.a.
Lead sponsor
Latis S.r.l.
Collaborator