Condition: Fatigue · Breast Cancer · Sponsor: Pharmanutra S.p.a.
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 f…
This description comes directly from the study's public registry record.
Maria Sole Rossato · 00390507846560 · ms.rossato@pharmanutra.it
Fabio Cattaneo · 00393896191056 · cattaneo@latiscro.it
Always discuss trial participation with your own doctor first.
| U.O.C. Oncologia medica ASST Spedali Civili di Brescia | Brescia, BRESCIA, Italy | Recruiting |
| Cancer Center U.O. Oncologia Medica ed Ematologia IRCCS Humanitas Research Hospital | Rozzano, MILANO, Italy | Recruiting |
| U.O. Oncologia 2 Universitaria A.O.U. Pisana | Pisa, PISA, Italy | Recruiting |
| UOSD di Medicina di Precisione e Senologia, Policlinico Universitario A. Gemelli | Rome, ROME, Italy | Recruiting |
| Dipartimento di Oncologia Azienda Sanitaria Universitaria Integrata di Udine | Udine, UDINE, Italy | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06137833