NCT06137833 Wide Spectrum Micronutrients Supplementation in Patients With Cancer Related Fatigue During Neoadjuvant and Adjuvant Chemotherapy
| NCT ID | NCT06137833 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pharmanutra S.p.a. |
| Condition | Fatigue |
| Study Type | INTERVENTIONAL |
| Enrollment | 92 participants |
| Start Date | 2023-11-27 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 92 participants in total. It began in 2023-11-27 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: 1. Females aged 18 or higher. 2. Patients diagnosed with histologically confirmed breast cancer. 3. 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 (\*). 4. Patients with ECOG performance status ≤1 at screening. 5. Patients with cancer related fatigue of moderate-severe intensity (Numerical Rating Scale NRS \> 4). 6. Patients able to follow the recommendations on the physical exercise to do. 7. Patients who accept to use adequate contraceptive methods, if they are of child-bearing potential. 8. Patients willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the protocol tests and procedures. (\*)Examples of chemotheraphy and standard therapeutic regimens in the neoadjuvant and adjuvant phase in breast cancer and on the basis of the biological characteristics of the neoplasm are as follows: Neoadjuvant Chemotheraphy * Epirubicin + Cyclophosphamide, 3 cycles -\> Taxol\* weekly for 12 weeks; * Epirubicin + Cyclophosphamide -\> Pertuzumab + Trastuzumab (or Phesgo) 3 cycles + Taxol weekly for 12 weeks; * Carboplatin + Taxol\* weekly for 12 weeks -\> Epirubicin + Cyclophosphamide; * Taxol could be replaced by Taxotere Adjuvant Chemotheraphy * Epirubicin + Cyclophosphamide, 4 cycles, every 21 days -\> Taxol weekly for 12 weeks * Epirubicin + Cyclophosphamide, 4 cycles, every 14 days -\> Taxol, 4 cycles every 14 days * Epirubicin + Cyclophosphamide, 4 cycles every 21 days -\> Taxol weekly + Trastuzumab with or without Pertuzumab for 1 year * Taxotere + Cyclophosphamide, 4 cycles, every 21 days. These lists are not to be considered exclusive Exclusion Criteria: 1. Women who are pregnant or breast-feeding. 2. Neoplastic disease other than primary breast cancer. 3. 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. 4. Patients with known or symptomatic metastases. 5. Patients unable to readily swallow. Patients with severe gastrointestinal disease (including esophagitis, gastritis, malabsorption, or obstructive symptoms) or intractable or frequent vomiting are excluded. 6. Patients with known or suspected allergy or hypersensitivity to the study products or any of their excipients. 7. Patients with an active, uncontrolled infection. 8. Patients with uncontrolled diabetes mellitus. 9. Patients with untreated clinically relevant hypothyroidism. 10. Patients with concomitant not-correctable alterations, present before chemotherapy, possible determinants of fatigue (NRS ≥ 4), such as anemia, not well controlled pain (NRS \> 4), insomnia, electrolyte imbalance, dehydration, anorexia/cachexia, hepatic, renal or heart failure, adrenocortical failure, neurological deficit. 11. Other clinical diagnosis, serious chronic diseases (renal failure with creatinine clearance \<30 ml / min; liver failure, heart failure with NYHA -New York Heart Association- class\> 2), ongoing or intercurrent illness that in the Investigator's opinion would prevent the patient's participation. 12. Patients receiving opioids or corticosteroids (except as replacement therapy at physiological dose, in subjects with adrenal insufficiency or to prevent emesis on the chemotherapy day). 13. Patients receiving parenteral nutrition (either total or partial). 14. Use of other investigational drug(s) within 30 days before study entry or during the study. 15. Triple negative patients in neoadjuvant treatment with Pembrolizumab.
Contact & Investigator
Alessandra Fabi
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT06137833 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Fatigue. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06137833 currently recruiting?
Yes, NCT06137833 is actively recruiting participants. Contact the research team at ms.rossato@pharmanutra.it for enrollment information.
Where is the NCT06137833 trial being conducted?
This trial is being conducted at Brescia, Italy, Rozzano, Italy, Pisa, Italy, Rome, Italy and 1 additional location.
Who is sponsoring the NCT06137833 clinical trial?
NCT06137833 is sponsored by Pharmanutra S.p.a.. The principal investigator is Alessandra Fabi at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 92 participants.