Phase
Condition
Vaginal Cancer
Pelvic Cancer
Treatment
Experimental product - Fortifit® Powder
Standard of care
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
histologically confirmed diagnosis of gynecologic cancer (ovarian, uterine,cervical);
indication for a first-line chemotherapy (adjuvant or curative) with aplatinum-based regimen to be used by investigator's choice within the framework ofgood clinical practice and in agreement with current Italian Association of MedicalOncology guidelines;
Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
signed informed consent.
Exclusion
Exclusion Criteria:
age <18 years
ECOG performance status >2
indication to or ongoing artificial nutrition support
known kidney failure (previous glomerular filtration rate <30 ml/min);
known liver failure (Child B or C)
endocrine disorders associated with disorders of calcium metabolism (excludingosteoporosis)
decompensated diabetes
indications related to the study product: more than 10 µg (400 IU) of daily VitaminD intake from medical sources More than 500 mg of daily calcium intake from medicalsources; adherence to a high energy or high protein diet up or use of proteincontaining or amino acid containing nutritional supplements up to three monthsbefore starting the study.
known allergy to milk, milk products or other components of the proposedinterventions
inclusion in other nutritional intervention trials
patients refusal
Study Design
Connect with a study center
IRCCS San Matteo
Pavia, 27100
ItalyActive - Recruiting

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