FatigueNCT06137833

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

A study testing APPOPRTAL® in people with Fatigue and Breast Cancer, run by Pharmanutra S.p.a. at 5 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Fatigue, Breast Cancer
What is being tested?: APPOPRTAL®
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 92 participants
Where: 5 sitesItaly
Study dates: 27 Nov 2023to 31 Dec 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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
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

Who cannot join

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.

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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.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Italy5 sites

U.O.C. Oncologia medica ASST Spedali Civili di Brescia
Brescia, BRESCIA, 25123
U.O. Oncologia 2 Universitaria A.O.U. Pisana
Pisa, PISA, 56126
UOSD di Medicina di Precisione e Senologia, Policlinico Universitario A. Gemelli
Rome, ROME, 00168
Cancer Center U.O. Oncologia Medica ed Ematologia IRCCS Humanitas Research Hospital
Rozzano, MILANO, 20089
Dipartimento di Oncologia Azienda Sanitaria Universitaria Integrata di Udine
Udine, UDINE, 33100

Other trials in Italy

About this study

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

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).

Read the detailed description

SAMPLE SIZE DETERMINATION Considering the average of the BFI 5 in the placebo group and the average 3 in the treated group, with standard deviation of 3, power at 80% and alpha 0.05, we obtain 37 patients per group, thus a total of 74 patients. If a drop-out rate of 20% is fixed, 92 patients in total are obtained. So, a sample of 92 subjects would be sufficient.

DATA SAFETY MONITORING BOARD / DATA MONITORING COMMITTEE No Data Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC) will be convened for the evaluation of safety data during the study. However, the Network Italiano Cure di Supporto in Oncologia (NICSO) society will be in charge of the evaluation of safety information. In fact, a Scientific Committee, composed by NICSO members, has been established to support the Sponsor in the continuous evaluation of safety data emerging from the study.

MONITORING AND QUALITY ASSURANCE The study will be monitored by adequately qualified and trained clinical monitors. Before the start of the study, the CRO (Contract Research Organization) responsible for the study site has the task to assess the adequacy of the study site and the staff involved. After start, the study will be monitored to ensure the proper conduct of the clinical study.

DATA COLLECTION An Electronic Case Report Form (e-CRF) will be used for recording patient's study data.

The Investigator will maintain a list of all persons authorized to make entries and/or corrections on the CRFs. Each authorized person will be provided with a user-specific ID (Identification) protected by a renewable password. Data entries and corrections will be made only by the authorized persons. The e-CRF system will record date and time of any entry and /or correction and the user ID of the person making the entry/correction. The system will keep track of all old and new values (audit trail).

Conditions: Fatigue, Breast Cancer
Being tested: APPOPRTAL®, Placebo
Medical subject headings: Fatigue, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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
PlaceboOther
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

Study groups in NCT06137833
Study group	Role	What they receive
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 Receives: 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 Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
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
Measured: 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
Blood samples of about 5 mL will be collected for the assessment of iron status (hemoglobin, ferritin, transferrin saturation), nutritional markers (albumin, total cholesterol, HDL, LDL and triglycerides), oxidative markers (homocysteine, uric acid) and C-Reactive Protein, serum L-arginine levels. Blood samples will be analysed locally by each site laboratory.
Measured: 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
Blood samples of about 5 mL will be collected for the assessment of iron status (hemoglobin, ferritin, transferrin saturation), nutritional markers (albumin, total cholesterol, HDL, LDL and triglycerides), oxidative markers (homocysteine, uric acid) and C-Reactive Protein, serum L-arginine levels. Blood samples will be analysed locally by each site laboratory.
Measured: 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
Blood samples of about 5 mL will be collected for the assessment of iron status (hemoglobin, ferritin, transferrin saturation), nutritional markers (albumin, total cholesterol, HDL, LDL and triglycerides), oxidative markers (homocysteine, uric acid) and C-Reactive Protein, serum L-arginine levels. Blood samples will be analysed locally by each site laboratory.
Measured: 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
Blood samples of about 5 mL will be collected for the assessment of iron status (hemoglobin, ferritin, transferrin saturation), nutritional markers (albumin, total cholesterol, HDL, LDL and triglycerides), oxidative markers (homocysteine, uric acid) and C-Reactive Protein, serum L-arginine levels. Blood samples will be analysed locally by each site laboratory.
Measured: Change after 8 weeks of study treatment with respect to baseline in both the active and placebo groups
Change in nutritional status through assessment of total cholesterol, HDL, LDL and triglycerides
Blood samples of about 5 mL will be collected for the assessment of iron status (hemoglobin, ferritin, transferrin saturation), nutritional markers (albumin, total cholesterol, HDL, LDL and triglycerides), oxidative markers (homocysteine, uric acid) and C-Reactive Protein, serum L-arginine levels. Blood samples will be analysed locally by each site laboratory.
Measured: Change after 8 weeks of study treatment with respect to baseline in both the active and placebo groups
Change in oxidative status through homocysteine assessment
Blood samples of about 5 mL will be collected for the assessment of iron status (hemoglobin, ferritin, transferrin saturation), nutritional markers (albumin, total cholesterol, HDL, LDL and triglycerides), oxidative markers (homocysteine, uric acid) and C-Reactive Protein, serum L-arginine levels. Blood samples will be analysed locally by each site laboratory.
Measured: Change after 8 weeks of study treatment with respect to baseline in both the active and placebo groups
Change in oxidative status through uric acid assessment
Blood samples of about 5 mL will be collected for the assessment of iron status (hemoglobin, ferritin, transferrin saturation), nutritional markers (albumin, total cholesterol, HDL, LDL and triglycerides), oxidative markers (homocysteine, uric acid) and C-Reactive Protein, serum L-arginine levels. Blood samples will be analysed locally by each site laboratory.
Measured: Change after 8 weeks of study treatment with respect to baseline in both the active and placebo groups
Change in oxidative status through C-Reactive Protein (CRP) assessment
Blood samples of about 5 mL will be collected for the assessment of iron status (hemoglobin, ferritin, transferrin saturation), nutritional markers (albumin, total cholesterol, HDL, LDL and triglycerides), oxidative markers (homocysteine, uric acid) and C-Reactive Protein, serum L-arginine levels. Blood samples will be analysed locally by each site laboratory.
Measured: Change after 8 weeks of study treatment with respect to baseline in CRP in both the active and placebo groups
Change in serum L-arginina levels
Blood samples of about 5 mL will be collected for the assessment of iron status (hemoglobin, ferritin, transferrin saturation), nutritional markers (albumin, total cholesterol, HDL, LDL and triglycerides), oxidative markers (homocysteine, uric acid) and C-Reactive Protein, serum L-arginine levels. Blood samples will be analysed locally by each site laboratory.
Measured: Change after 8 weeks of study treatment with respect to baseline in both the active and placebo groups
Changes in QoL through SF-12 Questionnaire
SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure.
The SF-12 is a shortened version of it's predecessor, the SF-36 and it was created to reduce the burden of response The SF-12 consists of twelve questions that measure the same eight domains as the SF-36, to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). Mental health-related scales include Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH).
Measured: Change after 4, 8 and 12 weeks with respect to baseline in both the active and placebo groups
Change in muscular strength (hand grip test),
Grip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles. It can be used as a screening tool for the measurement of upper body strength and overall strength. Within this clinical study an hand digital dynamometer will be used.
Measured: Change after 4, 8 and 12 weeks with respect to baseline in both the active and placebo groups
Overall patient's satisfaction with the product received, through a 5-points Likert scale
5-points Likert scale: 1=very satisfied, 2=satisfied, 3=not satisfied nor unsatisfied, 4=not satisfied, 5= not satisfied at all
Measured: End of treatment (after 8 weeks of study treatment), in both the active and placebo groups
Adherence to treatment
The percentage of actual sachets taken by the patient in relation to the expected number of sachets, calculated as (number of real sachets taken / number of expected sachets) * 100
Measured: After 4 weeks and after 8 weeks from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Nov 202331 Dec 2025

First posted18 Nov 2023
Study start27 Nov 2023
Primary completion31 Dec 2025
Study completion31 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (29)Papers the sponsor has linked to this study.
Other trials for FatigueStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 92 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06137833
Sponsor's protocol ID: APPORTAL-01-23
Status last verified: Sep 2025
First submitted: 16 Jul 2023
Last updated: 21 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.
PubMed 21296855
Jemal A, Center MM, DeSantis C, Ward EM. Global patterns of cancer incidence and mortality rates and trends. Cancer Epidemiol Biomarkers Prev. 2010 Aug;19(8):1893-907. doi: 10.1158/1055-9965.EPI-10-0437. Epub 2010 Jul 20.
PubMed 20647400
Siegel R, Naishadham D, Jemal A. Cancer statistics, 2012. CA Cancer J Clin. 2012 Jan-Feb;62(1):10-29. doi: 10.3322/caac.20138. Epub 2012 Jan 4.
PubMed 22237781
Mortimer JE, Barsevick AM, Bennett CL, Berger AM, Cleeland C, DeVader SR, Escalante C, Gilreath J, Hurria A, Mendoza TR, Rugo HS. Studying cancer-related fatigue: report of the NCCN scientific research committee. J Natl Compr Canc Netw. 2010 Dec;8(12):1331-9. doi: 10.6004/jnccn.2010.0101.
PubMed 21147900
Ruiz-Casado A, Alvarez-Bustos A, de Pedro CG, Mendez-Otero M, Romero-Elias M. Cancer-related Fatigue in Breast Cancer Survivors: A Review. Clin Breast Cancer. 2021 Feb;21(1):10-25. doi: 10.1016/j.clbc.2020.07.011. Epub 2020 Jul 24.
PubMed 32819836
So WK, Marsh G, Ling WM, Leung FY, Lo JC, Yeung M, Li GK. The symptom cluster of fatigue, pain, anxiety, and depression and the effect on the quality of life of women receiving treatment for breast cancer: a multicenter study. Oncol Nurs Forum. 2009 Jul;36(4):E205-14. doi: 10.1188/09.ONF.E205-E214.
PubMed 19581224
Gaston-Johansson F, Fall-Dickson JM, Bakos AB, Kennedy MJ. Fatigue, pain, and depression in pre-autotransplant breast cancer patients. Cancer Pract. 1999 Sep-Oct;7(5):240-7. doi: 10.1046/j.1523-5394.1999.75008.x.
PubMed 10687593
Berger AM, Abernethy AP, Atkinson A, Barsevick AM, Breitbart WS, Cella D, Cimprich B, Cleeland C, Eisenberger MA, Escalante CP, Jacobsen PB, Kaldor P, Ligibel JA, Murphy BA, O'Connor T, Pirl WF, Rodler E, Rugo HS, Thomas J, Wagner LI. NCCN Clinical Practice Guidelines Cancer-related fatigue. J Natl Compr Canc Netw. 2010 Aug;8(8):904-31. doi: 10.6004/jnccn.2010.0067. No abstract available.
PubMed 20870636
Cella D, Davis K, Breitbart W, Curt G; Fatigue Coalition. Cancer-related fatigue: prevalence of proposed diagnostic criteria in a United States sample of cancer survivors. J Clin Oncol. 2001 Jul 15;19(14):3385-91. doi: 10.1200/JCO.2001.19.14.3385.
PubMed 11454886
Sadler IJ, Jacobsen PB, Booth-Jones M, Belanger H, Weitzner MA, Fields KK. Preliminary evaluation of a clinical syndrome approach to assessing cancer-related fatigue. J Pain Symptom Manage. 2002 May;23(5):406-16. doi: 10.1016/s0885-3924(02)00388-3.
PubMed 12007758
Mustian KM, Alfano CM, Heckler C, Kleckner AS, Kleckner IR, Leach CR, Mohr D, Palesh OG, Peppone LJ, Piper BF, Scarpato J, Smith T, Sprod LK, Miller SM. Comparison of Pharmaceutical, Psychological, and Exercise Treatments for Cancer-Related Fatigue: A Meta-analysis. JAMA Oncol. 2017 Jul 1;3(7):961-968. doi: 10.1001/jamaoncol.2016.6914.
PubMed 28253393
Puetz TW, Herring MP. Differential effects of exercise on cancer-related fatigue during and following treatment: a meta-analysis. Am J Prev Med. 2012 Aug;43(2):e1-24. doi: 10.1016/j.amepre.2012.04.027.
PubMed 22813691
Mishra SI, Scherer RW, Geigle PM, Berlanstein DR, Topaloglu O, Gotay CC, Snyder C. Exercise interventions on health-related quality of life for cancer survivors. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD007566. doi: 10.1002/14651858.CD007566.pub2.
PubMed 22895961
Fabi A, Bhargava R, Fatigoni S, Guglielmo M, Horneber M, Roila F, Weis J, Jordan K, Ripamonti CI; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Cancer-related fatigue: ESMO Clinical Practice Guidelines for diagnosis and treatment. Ann Oncol. 2020 Jun;31(6):713-723. doi: 10.1016/j.annonc.2020.02.016. Epub 2020 Mar 12. No abstract available.
PubMed 32173483
Horneber M, Bueschel G, Dennert G, Less D, Ritter E, Zwahlen M. How many cancer patients use complementary and alternative medicine: a systematic review and metaanalysis. Integr Cancer Ther. 2012 Sep;11(3):187-203. doi: 10.1177/1534735411423920. Epub 2011 Oct 21.
PubMed 22019489

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study on Wide Spectrum Micronutrients Supplementation in Patients With Cancer Related Fatigue During Neoadjuvant and Adjuvant Chemotherapy
ClinicalTrials.gov ID: NCT06137833
Acronym / sponsor ID: APPORTAL-01-23
Conditions: Fatigue, Breast Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 92 participants (actual)
Lead sponsor: Pharmanutra S.p.a.Industry (pharma, biotech, devices)
Collaborators: Latis S.r.l.
Study start: 27 Nov 2023 (actual)
Primary completion: 31 Dec 2025 (actual)
Study completion: 31 Dec 2025 (actual)
First posted: 18 Nov 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Participants will receive the nutrition supplement or the placebo, in addition to the SoC (recommended physical exercise), for 8 weeks.

Detailed description

DATA COLLECTION An Electronic Case Report Form (e-CRF) will be used for recording patient's study data.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
APPORTAL®	Experimental	Dietary Supplement: APPOPRTAL®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
PLACEBO	Placebo comparator	Other: PlaceboPLACEBO 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

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (20 listed)

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).

Key exclusion criteria (15 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Dietary supplement	APPORTAL®
PlaceboIngredients: Maltodextrin, acidifying agent: citric acid, flavours, anticaking agent: tricalcium phosphate, beetroot juice powder; sweetener: sucralose, anti-caking agent: silicon dioxide, colouring agent: beta-carotene	Other	PLACEBO

Primary outcome

The change of fatigue perception by the patient through the BFI questionnaire
Time frame: Change from baseline to 8 weeks of treatment (Visit 3), in active and placebo groups.
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

14 secondary outcomes

The change of fatigue perception by the patient through the BFI questionnaire
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change after 8 weeks of study treatment with respect to baseline in both the active and placebo groups
Change in nutritional status through assessment of total cholesterol, HDL, LDL and triglycerides
Time frame: Change after 8 weeks of study treatment with respect to baseline in both the active and placebo groups
Change in oxidative status through homocysteine assessment
Time frame: Change after 8 weeks of study treatment with respect to baseline in both the active and placebo groups
Change in oxidative status through uric acid assessment
Time frame: Change after 8 weeks of study treatment with respect to baseline in both the active and placebo groups
Change in oxidative status through C-Reactive Protein (CRP) assessment
Time frame: Change after 8 weeks of study treatment with respect to baseline in CRP in both the active and placebo groups
Change in serum L-arginina levels
Time frame: Change after 8 weeks of study treatment with respect to baseline in both the active and placebo groups
Changes in QoL through SF-12 Questionnaire
Time frame: Change after 4, 8 and 12 weeks with respect to baseline in both the active and placebo groups
Change in muscular strength (hand grip test),
Time frame: Change after 4, 8 and 12 weeks with respect to baseline in both the active and placebo groups
Overall patient's satisfaction with the product received, through a 5-points Likert scale
Time frame: End of treatment (after 8 weeks of study treatment), in both the active and placebo groups
Adherence to treatment
Time frame: After 4 weeks and after 8 weeks from baseline

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
Background: PubMed 21296855Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.
Background: PubMed 20647400Jemal A, Center MM, DeSantis C, Ward EM. Global patterns of cancer incidence and mortality rates and trends. Cancer Epidemiol Biomarkers Prev. 2010 Aug;19(8):1893-907. doi: 10.1158/1055-9965.EPI-10-0437. Epub 2010 Jul 20.
Background: PubMed 22237781Siegel R, Naishadham D, Jemal A. Cancer statistics, 2012. CA Cancer J Clin. 2012 Jan-Feb;62(1):10-29. doi: 10.3322/caac.20138. Epub 2012 Jan 4.
Background: PubMed 21147900Mortimer JE, Barsevick AM, Bennett CL, Berger AM, Cleeland C, DeVader SR, Escalante C, Gilreath J, Hurria A, Mendoza TR, Rugo HS. Studying cancer-related fatigue: report of the NCCN scientific research committee. J Natl Compr Canc Netw. 2010 Dec;8(12):1331-9. doi: 10.6004/jnccn.2010.0101.
Background: PubMed 32819836Ruiz-Casado A, Alvarez-Bustos A, de Pedro CG, Mendez-Otero M, Romero-Elias M. Cancer-related Fatigue in Breast Cancer Survivors: A Review. Clin Breast Cancer. 2021 Feb;21(1):10-25. doi: 10.1016/j.clbc.2020.07.011. Epub 2020 Jul 24.
Background: PubMed 19581224So WK, Marsh G, Ling WM, Leung FY, Lo JC, Yeung M, Li GK. The symptom cluster of fatigue, pain, anxiety, and depression and the effect on the quality of life of women receiving treatment for breast cancer: a multicenter study. Oncol Nurs Forum. 2009 Jul;36(4):E205-14. doi: 10.1188/09.ONF.E205-E214.
Background: PubMed 10687593Gaston-Johansson F, Fall-Dickson JM, Bakos AB, Kennedy MJ. Fatigue, pain, and depression in pre-autotransplant breast cancer patients. Cancer Pract. 1999 Sep-Oct;7(5):240-7. doi: 10.1046/j.1523-5394.1999.75008.x.
Background: PubMed 20870636Berger AM, Abernethy AP, Atkinson A, Barsevick AM, Breitbart WS, Cella D, Cimprich B, Cleeland C, Eisenberger MA, Escalante CP, Jacobsen PB, Kaldor P, Ligibel JA, Murphy BA, O'Connor T, Pirl WF, Rodler E, Rugo HS, Thomas J, Wagner LI. NCCN Clinical Practice Guidelines Cancer-related fatigue. J Natl Compr Canc Netw. 2010 Aug;8(8):904-31. doi: 10.6004/jnccn.2010.0067. No abstract available.
Background: PubMed 11454886Cella D, Davis K, Breitbart W, Curt G; Fatigue Coalition. Cancer-related fatigue: prevalence of proposed diagnostic criteria in a United States sample of cancer survivors. J Clin Oncol. 2001 Jul 15;19(14):3385-91. doi: 10.1200/JCO.2001.19.14.3385.
Background: PubMed 12007758Sadler IJ, Jacobsen PB, Booth-Jones M, Belanger H, Weitzner MA, Fields KK. Preliminary evaluation of a clinical syndrome approach to assessing cancer-related fatigue. J Pain Symptom Manage. 2002 May;23(5):406-16. doi: 10.1016/s0885-3924(02)00388-3.
Background: PubMed 28253393Mustian KM, Alfano CM, Heckler C, Kleckner AS, Kleckner IR, Leach CR, Mohr D, Palesh OG, Peppone LJ, Piper BF, Scarpato J, Smith T, Sprod LK, Miller SM. Comparison of Pharmaceutical, Psychological, and Exercise Treatments for Cancer-Related Fatigue: A Meta-analysis. JAMA Oncol. 2017 Jul 1;3(7):961-968. doi: 10.1001/jamaoncol.2016.6914.
Background: PubMed 22813691Puetz TW, Herring MP. Differential effects of exercise on cancer-related fatigue during and following treatment: a meta-analysis. Am J Prev Med. 2012 Aug;43(2):e1-24. doi: 10.1016/j.amepre.2012.04.027.
American Cancer Society. Cancer facts \& figures 2012Link provided by the sponsor.
12-Item Short Form Survey (SF-12) - Standard Italian VersionLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alessandra Fabi principal investigator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing APPOPRTAL® in people with Fatigue and Breast Cancer, run by Pharmanutra S.p.a. at 5 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change of fatigue perception by the patient through the BFI questionnaire (time frame: Change from baseline to 8 weeks of treatment (Visit 3), in active and placebo groups.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06137833, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.