Oral stomatitis induced by everolimus treatment Digestive System Oral stomatitis induced by everolimus treatment
Conditions
Interventions
‘STOP’ is a prospective, multicentre, randomized (1:1), open-label study, aimed at comparing the incidence and duration of cases of mucositis of any grade in two groups of metastatic renal cell carcin
Sponsors
Italian Nephro-Oncology Group (GION)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients affected by locally advanced and/or metastatic RCC (of any histological subtype), for which a second or third line treatment with Everolimus was provided (as indicated by the Italian Medicines Agency [AIFA]) 2. Patients who received Everolimus as part of experimental protocols were included in the present study only if Everolimus was administered as monotherapy (not in combination) and any protocol in question did not explicitly prohibit the use of food supplements; age over 18 3. Written informed consent to join the study 4. ECOG Performance Status of 0, 1 or 2
Exclusion criteria
Exclusion criteria: Poor patient compliance, and ongoing systemic or oral infections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of Orasol Plus® in addition to standard oral hygiene in the prevention of Everolimus-induced mucositis evaluated through physical examination and patient's interview at T0 (screening), T1 (day +15 from treatment start), T2 (day +30), T3 (day +90) and T4 (day +150/study end). | — |
Secondary
| Measure | Time frame |
|---|---|
| All evaluated through physical examination and patient's interview at T0 (screening), T1 (day +15 from treatment start), T2 (day +30), T3 (day +90) and T4 (day +150/study end): 1. Pain and the consequent need for analgesic (NSAIDs, major analgesics, steroids) 2. Incidence of infectious episodes in the oral cavity 3. Evaluation of nutritional status | — |
Countries
Italy
Outcome results
None listed