No registrations found.
ID
Source
Brief title
Health condition
Vaccination, Influenza, Chemotherapy, breast cancer, colorectal cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
Adequate rise in antibody titre.
Secondary outcome
1. Antibody titres against the influenza virus before and after vaccination;
2. Ex vivo cellular immune response (cytokines, fine specificity) after vaccination.
Background summary
Background:
Patients treated with chemotherapy are at higher risk of influenza infection and mortality and morbidity are higher compared to healthy adults. Vaccination against the influenza virus can prevent these complications. Although vaccination in oncology patients is recommended, in the Netherlands, a protocol for vaccination during chemotherapy does not exist. In this study it is investigated whether vaccination
during chemotherapy is effective in reaching protective serum antibody concentrations and adequate cellular immune response. Moreover the timing of vaccination is investigated (early vs late vaccination).
Objective:
To evaluate the effect of chemotherapy on the serological and cellular immune response to influenza virus vaccination in patients with breast or colorectal cancer in order to establisch the optimal timing of vaccination during treatment with chemotherapy.
Study design:
Randomized Clinical Trial (Multicentre).
Study population:
1. Patients with breast cancer, treated with FEC- or TAC-containing, triweekly chemotherapy cycles at the time of influenza vaccination;
2. Patients with colorectal cancer, treated with Oxaliplatin-containing, triweekly chemotherapy cycles at the time of vaccination;
3. Healthy controls consisting of patients partners and healthy volunteers working in the hospital.
Intervention:
The influenza virus vaccine is given in the period October/November 2011.
Main studyparameters/endpoints:
Adequate rise in antibody titre.
Study objective
Patients treated with chemotherapy are at higher risk of influenza infection and mortality and morbidity are higher compared to healthy adults. Vaccination against the influenza virus can prevent these complications. Although vaccination in oncology patients is recommended, in the Netherlands, a protocol for vaccination during chemotherapy does not exist. In this study it is investigated whether vaccination
during chemotherapy is effective in reaching protective serum antibody concentrations and adequate cellular immune response. Moreover the timing of vaccination is investigated (early vs late vaccination).
Study design
Aim: Inclusion finalized by december 2011.
Intervention
The influenza virus vaccine is given in the period October/November 2011.
[default]
The Netherlands
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The Netherlands
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2720 |
| NTR-old | NTR2858 |
| Other | EudraCT number : 2011-001714-34 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |