Phase III Randomized Double-blind Cross-over trial of Supersaturated Calcium-phosphate rinse (Caphosol®) versus NaCl 0.9% in the relief of Oral Mucositis in patients receiving Targeted Therapy

Phase 3

Completed

• Conditions: oral disorders; oral mucositis; 10027656; 10040798

• Registration Number: NL-OMON39444
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

*Male and female subjects
* >=18 years of age
* Histological proof of cancer of any type
* 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

Exclusion Criteria

* Any previous systemic antineoplastic treatment within 4 weeks of initiation of current targeted anticancer therapy
* Current antineoplastic combination cytotoxic chemotherapy
* 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Assess the severity of patient-reported oral AEs as determined by the change<br /><br>in the VHNSS2.0(10) score 3 times a week, from onset of OM/S (aphthous-like),<br /><br>oral pain, taste change (dysgeusia), difficulty swallowing (dysphagia),<br /><br>difficulty oral intake, or dry mouth during the active oral rinse period with<br /><br>Caphosol® oral rinse versus NaCl 0.9% oral rinse, 4 times daily, 2 minutes with<br /><br>30 ml solution</p><br>