Optimalisation of the response to influenza virus vaccination in breast cancer and colorectal cancer patients immunocompromised due to chemotherapy.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20352

Enrollment

180

Registered

2011-04-18

Start date

2011-09-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Vaccination, Influenza, Chemotherapy, breast cancer, colorectal cancer

Interventions

The influenza virus vaccine is given in the period October/November 2011.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with breast cancer treated FEC- or TAC-containing triweekly chemotherapy at moment of vaccination; 2. Patients with colorectal cancer treated with Oxaliplatin-containing triweekly chemotherapy at moment of vaccination; 3. Age >18 years; 4. Signing informed consent; 5. Male and Female.

Exclusion criteria

Exclusion criteria: 1. Fever at time of vaccination defined as a temperature of > 38.5 C; 2. Previous/known allergic reaction to any of the components of the vaccines given, for example hypersensitivity to egg protein; 3. Thrombocytopenia (defined as < 50 * 109/L) at moment of vaccination.

Design outcomes

Primary

Measure	Time frame
Adequate rise in antibody titre.	—

Secondary

Measure	Time frame
1. Antibody titres against the influenza virus before and after vaccination; 2. Ex vivo cellular immune response (cytokines, fine specificity) after vaccination.	—

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)