oral mucositis in renal cell carcinoma, hepatocellular carcinoma, and gastrointestinal stromal tumor MedDRA version: 12.1 Level: LLT Classification code 10028127 Term: Mucositis MedDRA version: 12.1 Level: LLT Classification code 10042128 Term: Stomatitis MedDRA version: 12.1 Level: PT Classification code 10042128 Term: Stomatitis MedDRA version: 12.1 Level: LLT Classification code 10031009 Term: Oral pain MedDRA version: 12.1 Level: PT Classification code 10031009 Term: Oral pain MedDRA v
Conditions
Interventions
Trade Name: Caphosol
Product Name: supersaturated calcium phosphate rinse
Product Code: MDD93/42/CEE
Pharmaceutical Form: Oromucosal solution
INN or Proposed INN: calcium
CAS Number: 7440-70-2
Other d
Sponsors
Leiden University Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Male and female subjects ? =18 years of age ? Histological proof of RCC, HCC or GIST ? Oral adverse events > grade 0 due to sunitinib, sorafenib, pazopanib, temsirolimus, or everolimus in mono therapy at study entry ? Written informed consent ? Eastern Co-operative Oncology Group (ECOG) performance status = 2 ? Able to perform oral rinsing ? Able to complete questionnaires by themselves or with assistance Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Subjects meeting any of the following criteria will be excluded from the study: ? Any previous systemic antineoplastic treatment within 4 weeks of initiation of current targeted anticancer therapy ? Current antineoplastic combination cytotoxic chemotherapy therapy ? Physiologic condition that precludes the use of an oral rinse ? Hypersensitivity to Caphosol ingredients ? Use of palifermin, oral cryotherapy, low level laser therapy, topical oral steroids within 3 weeks of current targeted anticancer therapy ? Oral abnormalities defined as baseline oral assessment of NCI-CTCAE v4.0 grade > 0 ? Current use of agents that are known to be strong inducers or inhibitors of CYP3A4 that can not be stopped
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: None;Main Objective: To assess the effect of Caphosol® oral rinse on clinical outcomes of selected oral symptom burden (oral mucositis/stomatitis (aphthous-like), oral pain, taste change (dysgeusia), difficulty swallowing (dysphagia), difficulty oral intake, and dry mouth) associated with incidence of grade = 1 oral adverse events and the anticancer therapy cessation in patients treated with selected targeted anticancer therapy in selected tumors.;Primary end point(s): Assess the severity of patient-reported oral adverse events as determined by the change in the VHNSS2.0 score 3 times a week, from onset of oral mucositis, stomatitis (aphthous-like), oral pain, taste change (dysgeusia), difficulty swallowing (dysphagia), difficulty oral intake, or dry mouth during the active oral rinse period with Caphosol® oral rinse versus NaCl 0.9% oral rinse, 4 times daily, 2 minutes with 30 ml solution | — |
Countries
Netherlands
Outcome results
None listed