Micronutrient supplementation for fatigue in breast cancer patients during chemotherapy

Clinical Study on Wide Spectrum Micronutrients Supplementation in Patients With Cancer Related Fatigue During Neoadjuvant and Adjuvant Chemotherapy

This study is testing whether a micronutrient supplement can help breast cancer patients feel less tired during chemotherapy and improve their overall quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 92 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Pharmanutra S.p.a. (Industry-sponsored)
• Drugs / interventions: Pertuzumab, Trastuzumab, Pembrolizumab, chemotherapy, Cyclophosphamide
• Locations: 5 sites (Brescia, BRESCIA and 4 other locations)
• Trial ID: NCT06137833 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of APPORTAL®, a micronutrient supplement, on fatigue levels in breast cancer patients undergoing neoadjuvant and adjuvant chemotherapy. The study aims to determine if APPORTAL® can enhance energy levels, improve nutritional status, and boost quality of life while patients continue their standard physical exercise regimen. Participants will attend three study visits over an 8-week period, with assessments of fatigue, muscular strength, and overall satisfaction with the treatment. Safety and tolerability of the supplement will also be monitored throughout the trial.

Who should consider this trial

Good fit: Ideal candidates include females aged 18 or older with histologically confirmed breast cancer experiencing moderate to severe fatigue during chemotherapy.

Not a fit: Patients who are not currently undergoing chemotherapy or have a performance status greater than ECOG 1 may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly alleviate fatigue in breast cancer patients undergoing chemotherapy, improving their quality of life.

How similar studies have performed: While similar approaches have been explored, this specific supplementation strategy is relatively novel and has not been extensively tested in this context.

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.

Where this trial is running

Brescia, BRESCIA and 4 other locations

• 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)

Study contacts

• Principal investigator: Alessandra Fabi — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Study coordinator: Maria Sole Rossato

Conditions Fatigue; Breast Cancer