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…
ID
Bron
Verkorte titel
Aandoening
Vaccination, Influenza, Chemotherapy, breast cancer, colorectal cancer
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Adequate rise in antibody titre.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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).
Onderzoeksopzet
Aim: Inclusion finalized by december 2011.
Onderzoeksproduct en/of interventie
The influenza virus vaccine is given in the period October/November 2011.
Publiek
[default]
The Netherlands
Wetenschappelijk
[default]
The Netherlands
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2720 |
| NTR-old | NTR2858 |
| Ander register | EudraCT number : 2011-001714-34 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |