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

NCT06137833 | Recruiting

• 1 other identifier: APPORTAL-01-23
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 5

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).

Conditions

Fatigue; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• The change of fatigue perception by the patient through the BFI questionnaire

  The Brief Fatigue Inventory (BFI) is a questionnaire specifically developed for rapid assessment of CRF. It is a simple, easily administered questionnaire and the fatigue scale (validated in different languages) consists in nine items anticipated by a flag question asking the patient whether she has felt unusually fatigued or tired during the last week. Three items are related to the intensity of fatigue "right now", at its "usual" level and at its "worst" level during the past 24 h using a 0-10 numerical scale (0= no fatigue, 10= fatigue as bad as you can image). Six items measure the interference of fatigue with the patients' life during the past 24 h by a 0-10 numerical scale (0= does not interfere, 10= completely interferes). Higher scores represent to more severe fatigue

  Change from baseline to 8 weeks of treatment (Visit 3), in active and placebo groups.

Secondary Outcomes (14)

• The change of fatigue perception by the patient through the BFI questionnaire

  Change after 4, 8 and 12 weeks with respect to baseline in both the active and placebo groups

• Change in Iron status through hemoglobin assessment

  Change after 8 weeks of study treatment with respect to baseline, in both the active and placebo groups

• Change in Iron status through ferritin assessment

  Change after 8 weeks of study treatment with respect to baseline, in both the active and placebo groups

• Change in Iron status through transferrin saturation assessment

  Change after 8 weeks of study treatment with respect to baseline in both the active and placebo groups

• Change in nutritional status through albumin assessment

  Change after 8 weeks of study treatment with respect to baseline in both the active and placebo groups

Other Outcomes (8)

• Study product tolerability

  Through study completion, an average of 12 weeks, in active and placebo groups

• Change in Physical Examination through weight measurement

  Change after 4, 8 and 12 weeks from baseline in both the active and placebo groups

• Change in Physical Examination through BMI evaluation

  Change after 4, 8 and 12 weeks from baseline in both the active and placebo groups

Study Arms (2)

APPORTAL®

EXPERIMENTAL

APPORTAL® sachet, 1 sachet per day dissolved in a glass of water. To be consumed in the morning, about 10 minutes after breakfast. Dosage form: powder Route: Oral Treatment duration: 8 weeks

Dietary Supplement: APPOPRTAL®

PLACEBO

PLACEBO COMPARATOR

PLACEBO sachet, 1 sachet per day dissolved in a glass of water To be consumed in the morning, about 10 minutes after breakfast. Dosage form: powder Route: Oral Treatment duration: 8 weeks

Other: Placebo

Interventions

APPOPRTAL® DIETARY_SUPPLEMENT

1 sachet of APPORTAL® contains: Vitamin C 37,5 mg; Vitamin E 30 mg; Vitamin PP 18 mg; Vitamin B1 1 mg; Vitamin D 25 μg; Vitamin H 25 μg; L-arginine 1000 mg; L-carnitine 500 mg; Taurine 25 mg; Ginseng e.s. 100 mg; Eleutherococcus e.s. 50 mg; Magnesium 187,5 mg; Iron 14 mg; Zinc 1,5 mg; Iodine 75 μg; Selenium 27,5 μg; Coenzyme Q10 100 mg; Lycopene 3,06 mg; Tocotrienols 2,5 mg; Coenzyme Q10 100 mg; Lycopene 3,06 mg; Tocotrienols 2,5 mg

APPORTAL®

Placebo OTHER

Ingredients: Maltodextrin, acidifying agent: citric acid, flavours, anticaking agent: tricalcium phosphate, beetroot juice powder; sweetener: sucralose, anti-caking agent: silicon dioxide, colouring agent: beta-carotene

PLACEBO

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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 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

You may not qualify 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 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.
• 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, dehydration, anorexia/cachexia, hepatic, renal or heart failure, adrenocortical failure, neurological deficit.
• 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.
• 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).
• 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.

Sponsors & Collaborators

• Pharmanutra S.p.a.: lead
• Latis S.r.l.: collaborator

Study Sites (5)

U.O.C. Oncologia medica ASST Spedali Civili di Brescia

Brescia, BRESCIA, 25123, Italy

RECRUITING

Cancer Center U.O. Oncologia Medica ed Ematologia IRCCS Humanitas Research Hospital

Rozzano, MILANO, 20089, Italy

RECRUITING

U.O. Oncologia 2 Universitaria A.O.U. Pisana

Pisa, PISA, 56126, Italy

RECRUITING

UOSD di Medicina di Precisione e Senologia, Policlinico Universitario A. Gemelli

Rome, ROME, 00168, Italy

RECRUITING

Dipartimento di Oncologia Azienda Sanitaria Universitaria Integrata di Udine

Udine, UDINE, 33100, Italy

RECRUITING

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Related Links

• American Cancer Society. Cancer facts \& figures 2012
• 12-Item Short Form Survey (SF-12) - Standard Italian Version

MeSH Terms

Conditions

Fatigue; Breast Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Alessandra Fabi

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Sole Rossato

CONTACT

00390507846560; ms.rossato@pharmanutra.it

Fabio Cattaneo

CONTACT

00393896191056; cattaneo@latiscro.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2023
• First Posted: November 18, 2023
• Study Start: November 27, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (5)