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…
ID
Source
Brief title
Condition
- Viral infectious disorders
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
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
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 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
The study comprises patients treated with chemotherapy for breast cancer, for
colorectal cancer and a control-group.
The design for is a randomised trial. The serological and cellular response to
influenza virus vaccination will be measured in cancer patients randomised for
early or late vaccination. The early group will be vaccinated at day 5 +/- 1
day of the chemotherapy cycle, the late group at day 16 +/- 1 day of the
chemotherapy cycle. All responses will be compared to the response of healthy
controls with indication for vaccination according to the RIVM. (partners of
patients > 60 years old and hospital personnel)
Intervention
The influenza virus vaccine is given in the period October/November 2011.
Study burden and risks
Adverse effects to vaccination in oncology patients overall are mild. in
general, side-effects of influenza vaccination are soreness at the injection
site and, less commonly, fever, malaise, myalgia, arthralgia, or both, starting
6-12 h after vaccination and lasting less than 48 h. The risk of venapunction
consists of a haematoma on the injection site. In conclusion, it is expected
that the risks of the immunisation are small, whereas considerable morbidity
can be prevented by vaccination.
Koekoekslaan 1
3435 CM Nieuwegein
NL
Koekoekslaan 1
3435 CM Nieuwegein
NL
Listed location countries
Age
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
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
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2011-001714-34-NL |
| CCMO | NL36449.100.11 |
| Other | volgt |