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ID
Source
Brief title
Health condition
Testicular germ-cell cancer, cancer-related fatigue, mitochondrial DNA, bleomycin, etoposide, cisplatin, BEP-chemotherapy
Testiscarcinoom, kanker gerelateerde vermoeidheid, mitochondriaal DNA, bleomycine, etoposide, cisplatine, BEP-chemotherapie
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine whether chemotherapy for metastatic germ cell cancer of the testis
(bleomycin/etoposide/cisplatin) induces changes in mtDNA of non-cancer cells that persist after completion of chemotherapy. This will give indirect information on possible impairment of mitochondrial functioning.
Secondary outcome
- To determine whether persistent mitochondrial impairment is observed in these non-cancer cells.
- To determine the severity of fatigue before, during and after the chemotherapy cycles and its relation with the occurrence of changes in mtDNA in non-cancer cells.
Background summary
Fatigue is a problem frequently experienced by cancer patients. Unfortunately, the pathogenesis of fatigue is still unknown. A few studies show that the administration of chemotherapy is associated with changes in the DNA of mitochondria (mtDNA), small organelles responsible for the energy production of the cell. However, whether chemotherapy changes mtDNA in healthy cells and which consequences that may bear have not been investigated. We hypothesize that chemotherapy for metastatic germ cell cancer of the testis induces mitochondrial impairment and/or off-target changes in mitochondrial DNA of healthy cells which possibly persists after completion of chemotherapy regimen. If so, this might contribute to the elucidation of the pathophysiology of cancer-related fatigue.
Study objective
We hypothesize that changes in mitochondrial DNA and functional mitochondrial defects are detectable in blood cells during and after treatment with BEP-chemotherapy.
Study design
- Before the administration of the first cycle chemotherapy
- Before the administration of the second cycle chemotherapy
- Before the administration of the third cycle chemotherapy
- At the second follow-up visit after completing chemotherapy (±14 weeks)
Intervention
Blood draw (10mL of blood) for collection of peripheral white blood cells to study mitochondrial functioning and DNA quality before the administration of each BEP cycle (3x) and at follow-up (1x).
C.C.D. Rijt, van der
Rotterdam 3008 AE
The Netherlands
+31 (0)10 4391906
c.vanderrijt@erasmusmc.nl
C.C.D. Rijt, van der
Rotterdam 3008 AE
The Netherlands
+31 (0)10 4391906
c.vanderrijt@erasmusmc.nl
Inclusion criteria
- Planned to receive three cycles of chemotherapy (bleomycin, etoposide, cisplatin) for metastatic testicular cancer
- Age of 18 years or older
- Able to write and speak Dutch
- Provide informed consent
Exclusion criteria
- Cognitive impairments (i.e. inability to understand patient information leaflet or fatigue
questionnaires)
- Chronic Fatigue Syndrome or fibromyalgia
- Received chemotherapy before
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7180 |
| NTR-old | NTR7372 |
| CCMO | NL58942.078.16 |
| OMON | NL-OMON45432 |