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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON38087
Enrollment
100
Registered
2011-12-02
Start date
2012-09-12
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mucositis stomatitis

Interventions

Caphosol will be used 4x daily according to manufactures description.

Sponsors

Maxima Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
To evaluate the effectiveness of a calcium phosphate mouth rinse (Caphosol) on the burden of disease of moderate and severe oral mucositis (WHO scale grade II-IV)

Secondary

MeasureTime frame
The effect of oral mucositis on planned chemotherapy dosing The consumption of hospital resources used to treat oral mucositis

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)