Changes to the mitochondrial DNA in non-cancer cells induced by chemotherapy and the relation with fatigue in men with germ-cell cancer of the testis: a feasibility study.

Changes to the mitochondrial DNA in non-cancer cells induced by chemotherapy and the relation with fatigue in men with germ-cell cancer of the testis: a feasibility study. - Mitochondrial DNA and fatigue.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45432

Enrollment

Registered

2016-11-29

Start date

2017-02-24

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue in men with testicular cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Men with metastatic germ cell cancer of the testis planned to receive three cycles of BEP chemotherapy (bleomycin, etoposide, cisplatin) -Signed informed consent

Exclusion criteria

Exclusion criteria: -Received chemotherapy before -Chronic Fatigue Syndrome or fibromyalgia

Design outcomes

Primary

Measure	Time frame
A decrease >=30% in the number of mtDNA molecules per cell AND/OR an increase of >=11 damage lesion per 10 kb in mtDNA of blood cells during chemotherapy (measurements 2 and 3) and three months after completing chemotherapy (measurement 4), compared to baseline (measurement 1).	—

Secondary

Measure	Time frame
The severity of physical fatigue and mental fatigue at baseline (measurement 1), during chemotherapy (measurement 2 and 3), and three months after completing chemotherapy (measurement 4). Mitochondrial functioning in blood cells at baseline (measurement 1), during chemotherapy (measurement 2 and 3), and three months after completing chemotherapy (measurement 4).	—

Countries

Netherlands

Outcome results