Caphosol as a therapeutic option in patients with breast- or colorectal cancer at risk for chemotherapy-induced oral mucositis

Completed

• Conditions: 10006291; mucositis; stomatitis

• Registration Number: NL-OMON38087
• Lead Sponsor: Maxima Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

* Patients 18 years or older
* Patients first diagnosed with breast cancer receiving FE100C x6, FE100C x3 and docetaxel x3, TAC x6, FAC x6, AC x4 followed with Docetaxel x4, AC x4 followed with Docetaxel/Trastuzumab x4. Patients diagnosed with first colorectal cancer receiving FOLFOX-IV x9 (+/- bevacizumab), XelOx x8 (+/- bevacizumab)
* Patients with clinically assessed >grade 2 oral mucositis in any of the first three cycles of chemotherapy and that receive at least two subsequent chemotherapy cycles of the same therapeutic agent
* Willingness not to use marketed oral mucositis drugs, rinses or artificial saliva (Gelclair, Mugard, Evomucy, Biotene, Oral Balance, Magic Mouthwash) for 2 cycles when on standard oral care
* Written informed consent

Exclusion Criteria

*Receiving palifermin
*Receiving low level laser therapy
*Dose adjustment in chemotherapy dosages up till the chemotherapy cycle following the chemotherapy cycle in which oral mucositis > grade 2 is assessed.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate the effectiveness of a calcium phosphate mouth rinse (Caphosol) on<br /><br>the burden of disease of moderate and severe oral mucositis (WHO scale grade<br /><br>II-IV)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The effect of oral mucositis on planned chemotherapy dosing<br /><br>The consumption of hospital resources used to treat oral mucositis</p><br>