Trial Title:
Wide Spectrum Micronutrients Supplementation in Patients With Cancer Related Fatigue During Adjuvant Chemotherapy
NCT ID:
NCT06137833
Condition:
Fatigue
Breast Cancer
Conditions: Official terms:
Fatigue
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Triple (Participant, Care Provider, Investigator)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
APPOPRTAL®
Description:
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
Arm group label:
APPORTAL®
Intervention type:
Other
Intervention name:
Placebo
Description:
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
Arm group label:
PLACEBO
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 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).
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).
Criteria for 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 adjuvant chemotherapy (independently from
type of chemotherapy) (*).
4. Patients with ECOG (Eastern Cooperative Oncology Group) 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.
(*) The chemotherapy used and standard therapeutic regimens in the adjuvant phase in
breast cancer and on the basis of the biological characteristics of the neoplasm are as
follows: 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.
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Center U.O. Oncologia Medica ed Ematologia IRCCS Humanitas Research Hospital
Address:
City:
Rozzano
Zip:
20089
Country:
Italy
Contact:
Last name:
LAURA VELUTTI
Investigator:
Last name:
LAURA VELUTTI
Email:
Principal Investigator
Facility:
Name:
U.O.C. Oncologia medica ASST Spedali Civili di Brescia
Address:
City:
Brescia
Zip:
25123
Country:
Italy
Contact:
Last name:
REBECCA PEDERSINI
Investigator:
Last name:
REBECCA PEDERSINI
Email:
Principal Investigator
Facility:
Name:
Dipartimento di Area Medica - Oncologia A.O. S. Croce e Carle
Address:
City:
Cuneo
Zip:
12100
Country:
Italy
Contact:
Last name:
ANNA MARIA VANDONE
Investigator:
Last name:
ANNA MARIA VANDONE
Email:
Principal Investigator
Facility:
Name:
U.O. Oncologia 2 Universitaria A.O.U. Pisana
Address:
City:
Pisa
Zip:
56126
Country:
Italy
Contact:
Last name:
ANDREA FONTANA
Investigator:
Last name:
ANDREA FONTANA
Email:
Principal Investigator
Facility:
Name:
U.O.C. di Oncologia Medica A A.O.U. Policlinico Umberto I
Address:
City:
Roma
Zip:
00161
Country:
Italy
Contact:
Last name:
DANIELE SANTINI
Investigator:
Last name:
DANIELE SANTINI
Email:
Principal Investigator
Facility:
Name:
UOSD di Medicina di Precisione e Senologia, Policlinico Universitario A. Gemelli
Address:
City:
Rome
Zip:
00168
Country:
Italy
Contact:
Last name:
ALESSANDRA FABI
Investigator:
Last name:
ALESSANDRA FABI
Email:
Principal Investigator
Facility:
Name:
Dipartimento di Oncologia Azienda Sanitaria Universitaria Integrata di Udine
Address:
City:
Udine
Zip:
33100
Country:
Italy
Contact:
Last name:
STEFANIA RUSSO
Investigator:
Last name:
STEFANIA RUSSO
Email:
Principal Investigator
Start date:
November 27, 2023
Completion date:
December 27, 2024
Lead sponsor:
Agency:
Pharmanutra S.p.a.
Agency class:
Industry
Collaborator:
Agency:
Latis S.r.l.
Agency class:
Industry
Source:
Pharmanutra S.p.a.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06137833
https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2012.html
https://www.studocu.com/it/document/universita-degli-studi-di-torino/psiconcologia-e-cure-palliative-psycho-oncology/sf12-questionario/11590607
