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


- candidate number9346
- NTR NumberNTR2858
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-apr-2011
- Secondary IDs2011-001714-34  EudraCT number
- Public TitleOptimalisation of the response to influenza virus vaccination in breast cancer and colorectal cancer patients immunocompromised due to chemotherapy.
- Scientific TitleOptimalisation of the response to influenza virus vaccination in breast cancer and colorectal cancer patients immunocompromised due to chemotherapy.
- ACRONYMOFLUVAC
- hypothesisPatients 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).
- Healt Condition(s) or Problem(s) studiedBreast cancer, Colorectal cancer, Chemotherapy, Vaccine, Influenza
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2011
- planned closingdate1-feb-2012
- Target number of participants180
- InterventionsThe influenza virus vaccine is given in the period October/November 2011.
- Primary outcomeAdequate rise in antibody titre.
- Secondary outcome1. Antibody titres against the influenza virus before and after vaccination;
2. Ex vivo cellular immune response (cytokines, fine specificity) after vaccination.
- TimepointsAim: Inclusion finalized by december 2011.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES
- CONTACT for SCIENTIFIC QUERIES
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryBackground:
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.
- Main changes (audit trail)
- RECORD18-apr-2011 - 25-apr-2011


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