Actively Recruiting
Wide Spectrum Micronutrients Supplementation in Patients With Cancer Related Fatigue During Neoadjuvant and Adjuvant Chemotherapy
Led by Pharmanutra S.p.a. · Updated on 2025-10-01
92
Participants Needed
5
Research Sites
109 weeks
Total Duration
On this page
Sponsors
P
Pharmanutra S.p.a.
Lead Sponsor
L
Latis S.r.l.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Wide Spectrum Micronutrients Supplementation in Patients With Cancer Related Fatigue During Neoadjuvant and Adjuvant Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 years or older
- Histologically confirmed diagnosis of breast cancer
- Received at least one cycle of neoadjuvant or adjuvant chemotherapy and currently on active chemotherapy during the study
- ECOG performance status of 1 or less at screening
- Moderate to severe cancer-related fatigue with Numerical Rating Scale above 4
- Able to follow physical exercise recommendations
- Willing to use adequate contraception if of childbearing potential
- Able and willing to provide signed informed consent and comply with study procedures
You will not qualify if you...
- Pregnant or breastfeeding women
- Presence of cancers other than primary breast cancer
- Major surgery within 4 weeks prior to randomization (excluding breast cancer surgery, central venous access, or biopsies)
- Known or symptomatic metastases
- Difficulty swallowing or severe gastrointestinal disease or frequent vomiting
- Known allergy or hypersensitivity to study products or their ingredients
- Active uncontrolled infections
- Uncontrolled diabetes mellitus
- Untreated clinically relevant hypothyroidism
- Pre-existing conditions causing fatigue such as anemia, uncontrolled pain, insomnia, electrolyte imbalance, dehydration, anorexia/cachexia, liver, kidney, heart failure, adrenal insufficiency, or neurological deficits
- Serious chronic diseases or conditions preventing participation as judged by investigator
- Use of opioids or corticosteroids except physiological replacement or chemotherapy emesis prevention
- Receiving parenteral nutrition (total or partial)
- Use of other investigational drugs within 30 days before or during the study
- Triple negative breast cancer patients receiving Pembrolizumab in neoadjuvant treatment
AI-Screening
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Trial Site Locations
Total: 5 locations
1
U.O.C. Oncologia medica ASST Spedali Civili di Brescia
Brescia, BRESCIA, Italy, 25123
Actively Recruiting
2
Cancer Center U.O. Oncologia Medica ed Ematologia IRCCS Humanitas Research Hospital
Rozzano, MILANO, Italy, 20089
Actively Recruiting
3
U.O. Oncologia 2 Universitaria A.O.U. Pisana
Pisa, PISA, Italy, 56126
Actively Recruiting
4
UOSD di Medicina di Precisione e Senologia, Policlinico Universitario A. Gemelli
Rome, ROME, Italy, 00168
Actively Recruiting
5
Dipartimento di Oncologia Azienda Sanitaria Universitaria Integrata di Udine
Udine, UDINE, Italy, 33100
Actively Recruiting
Research Team
M
Maria Sole Rossato
CONTACT
F
Fabio Cattaneo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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