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New treatment option for Fatigue
Official title Wide Spectrum Micronutrients Supplementation in Patients With Cancer Related Fatigue During Neoadjuvant and Adjuvant Chemotherapy
ClinicalTrials.gov ID: NCT06137833
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- Patients with ECOG performance status ≤1 at screening.
- Patients with cancer related fatigue of moderate-severe intensity (Numerical Rating Scale NRS \> 4).
You likely can't join if
- 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...
- Patients with known or symptomatic metastases.
- Patients unable to readily swallow. Patients with severe gastrointestinal disease (including esophagitis, gastritis, malabsorption, or obstructive...
- Patients with known or suspected allergy or hypersensitivity to the study products or any of their excipients.
See the full eligibility criteria
- 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.
- Patients with cancer related fatigue of moderate-severe intensity (Numerical Rating Scale NRS \> 4).
- Patients able to follow the recommendations on the physical exercise to do.
- Patients who accept to use adequate contraceptive methods, if they are of child-bearing potential.
- 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...
- 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
- 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...
- Patients with known or symptomatic metastases.
- Patients unable to readily swallow. Patients with severe gastrointestinal disease (including esophagitis, gastritis, malabsorption, or obstructive symptoms) or intractable or frequent vomiting are excluded.
- Patients with known or suspected allergy or hypersensitivity to the study products or any of their excipients.
- Patients with an active, uncontrolled infection.
- Patients with uncontrolled diabetes mellitus.
- Patients with untreated clinically relevant hypothyroidism.
- 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...
- Other clinical diagnosis, serious chronic diseases (renal failure with creatinine clearance \ 2), ongoing or intercurrent illness that in the Investigator's opinion would prevent the patient's participation.
- Patients receiving opioids or corticosteroids (except as replacement therapy at physiological dose, in people with adrenal insufficiency or to prevent emesis on the chemotherapy day).
- Patients receiving parenteral nutrition (either total or partial).
- Use of other investigational drug(s) within 30 days before study entry or during the study.
- Triple negative patients in neoadjuvant treatment with Pembrolizumab.
The study team makes the final eligibility decision.
Where it's taking place
- Brescia, BRESCIA, Italy
- Rozzano, MILANO, Italy
- Pisa, PISA, Italy
- Rome, ROME, Italy
- Udine, UDINE, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brescia, BRESCIA, Italy; Rozzano, MILANO, Italy; Pisa, PISA, Italy; Rome, ROME, Italy; Udine, UDINE, Italy. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.