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

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

Interventions

DIETARY_SUPPLEMENT

APPOPRTAL®

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

OTHER

Placebo

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

Sponsors & Collaborators

• Latis S.r.l.

  collaborator INDUSTRY

• Pharmanutra S.p.a.

  lead INDUSTRY

Principal Investigators

• Alessandra Fabi · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-27

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• Italy

Study Locations