·To compare the serological response to influenza vaccination in mamma carcinoma patients treated with FEC-containing, triweekly regimens at day 4 ( +/- 1 day) of the chemotherapy cyclus with the response to vaccination in otherwise healthy patients…
ID
Source
Brief title
Condition
- Viral infectious disorders
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
adequate rise in antibody titre against the influenza virus
Secondary outcome
·Antibody titres against the influenza virus before and after vaccination
Background summary
Patients treated with chemotherapy or immunosuppressives 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
Study objective
·To compare the serological response to influenza vaccination in mamma
carcinoma patients treated with FEC-containing, triweekly regimens at day 4 (
+/- 1 day) of the chemotherapy cyclus with the response to vaccination in
otherwise healthy patients with heart failure (with proven equal rise in
antibody titre compared to healthy volunteers).
·To compare the serological response to influenza vaccination in mamma
carcinoma patients treated with FEC-containing, triweekly regimens at day 16 (
+/- 1 day) of the chemotherapy cyclus with the response to vaccination in
otherwise healthy patients with heart failure (with proven equal rise in
antibody titre compared to healthy volunteers).
·To compare the serological response to influenza virus vaccination in mamma
carcinoma patients treated with FEC-containing, triweekly regimens on two
different moments of vaccination: at day 4 ( +/- 1 day) versus day 16 (+/- 1
day) of the chemotherapy cyclus.
Study design
The study comprises patients with chemotherapy for mammacarcinoma and a control
group of heart failure patients. vaccination will be measured in mamma
carcinoma patients, randomised for early or late vaccination. The early group
will be vaccinated at day 4 +/- 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 in heart failure patients.
Intervention
The influenza virus vaccine is given in the period October/November 2009
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 mamma carcinoma treated with FEC-containing triweekly chemotherapy at moment of vaccination
2.Patients with heart failure and therefore having an indication for the influenza vaccination
3.Age >= 18 years
4.Signing of 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 x 10*9/L ) at moment of vaccination
4.Treatment with prednisolone on 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 |
|---|---|
| EudraCT | EUCTR2009-014340-11-NL |
| CCMO | NL28941.000.09 |