Health Status and Burden of Late Effects in Very Long-term Testicular Cancer Survivors (STANDBY-study)

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Health Status and Burden of Late Effects in Very Long-term Testicular Cancer Survivors (STANDBY-study)

Condition: Testicular Cancer

Purpose: Depending on disease stage, testicular cancer (TC) treatment consists of an orchidectomy, alone or followed by radiotherapy (RT) or platinum-based chemotherapy (CT). TC survival rates are above 90% nowadays, which results in growing TC survivor population. Because of the long life expectancy of these survivors, prevention or early detection of late treatment effects has become increasingly relevant. Yet known late effects are nephrotoxicity, cardiovascular disease (CVD), secondary malignant neoplasms (SMN), neurotoxicity, pulmonary toxicity, Raynaud’s phenomenon, hypogonadism, fatigue and psychosocial problems. Nephrotoxicity is an important late effect, but data is lacking in very long-term survivors since performed studies have a follow-up duration of 5-14 years. Decreased renal function is a known risk factor for CVD development and also an association between renal function and neurtoxicity via circulating platinum levels has been shown. It is hypothesized that treatment induced nephrotoxicity is prevalent in TC survivors and might be a mediator for development of late effects. The secondary aim is to assess prevalence of late effects in very long-term TC survivors: until now, most data have been collected through questionnaires in large epidemiological studies in TC survivors till approximately 10 years after treatment. The prevalence of late effects may increase over time: 10 years after treatment late effects may not be present yet, whilst late effects can emerge just after 20 years. Consequently, health status and possible late effects, resulting in morbidity, are underestimated in patients who are 20-30 years after treatment. By investigating health status of these very long-term survivors a more profound insight in the prevalence and aetiology of these late effects and the development over time can be assessed. Current treatment is very similar to TC treatment 20-30 years ago and therefore knowledge on late effects is relevant for currently treated patients. Furthermore, as a result of this study, we will better understand which factors and issues should be watched closely during follow-up, which TC survivors are at increased risk of developing late treatment effects and how to detect early damage before overt morbidity occurs.

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT02572934

Sponsor: University Medical Center Groningen

Primary Outcome Measures:

  • Measure: Glomerular filtration rate (GFR) in ml/min
  • Time Frame: 3 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Development of cardiovascular disease (CVD) according to the WHO ICD-10 classification (I10-I15: hypertensive disease; I20-I25: ischemic heart disease; I60-I69: cerebrovascular disease; I70-I79: disease of arteries, arterioles and capillaries)
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Peripheral neuropathy (anamnestic with SCIN questionnaire which assesses a.o. chemotherapy-induced peripheral sensory neuropathy)
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Raynaud’s phenomenon (anamnestic with SCIN questionnaire which assesses a.o. Raynaud’s phenomenon and objectified with standardized digital cooling tests)
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Lung function (FEV1, FVC, TLC, RV, FRC and diffusion capacity (DLCO, KCO))
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Hypogonadism (LH > 10 U/l or testosterone < 14 ng/ml)
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Cognitive function (neuropsychological assessment of different domains: learning, memory, processing speed, executive function)
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Fatigue (scaled; VVV-questionnaire)
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Testicular cancer disease characteristics: stage, prognosis group, chemotherapy regimen/dose, radiotherapy doses/location
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Health-related quality of life (HRQoL)
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Physical fitness (according to six-minute walk test with sex, age and BMI specific reference values)
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Intima media thickness (IMT)
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Advanced Glycation End products (AGEs)
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Cardiovascular risk factors (presence of hypertension, dyslipidemia, impaired fasting glucose, overweight/obesity, tobacco and alcohol use, family history)
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Genetic susceptibility for (cardio)vascular damage (single nucleotide polymorphisms (SNPs) in DNA)
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Leukocyte telomere length
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Arterial stiffness measured as pulse-wave velocity (PWV)
  • Time Frame: 3 years
  • Safety Issue:

Estimated Enrollment: 280

Study Start Date: August 2015

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Eligibility:

  • Age: minimum 18 Years maximum 70 Years
  • Gender: Male

Inclusion Criteria:

  1. Age <70 years at time of inclusion
  2. Signed informed consent
  3. CT-, RT- and SU-group: Age at start of TC treatment <40 yrs.
  4. CT-, RT- and SU-group: At least 20 years after start of treatment for TC at time of inclusion.
  5. CT-group: Patients treated with cisplatin-based chemotherapy for TC with good or intermediate prognosis (according to IGCCCG prognosis group).
  6. RT-group: Patients treated with radiotherapy for TC stage I or II.
  7. SU-group: Patients treated with orchidectomy only for TC stage I.

Exclusion Criteria:

  1. Mental disorder (no informed consent available).
  2. CT-group: Patients also treated with radiotherapy for TC.
  3. RT-group: Patients also treated with chemotherapy for TC.
  4. SU-group: Patients also treated with chemo- or radiotherapy for TC.
  5. CO-group: Treated with chemotherapy, radiotherapy or hormonal therapy for any type of cancer.

Contact:

  • Jourik Gietema, MDPhD
  • 0031 (0)50-3612821

Location:

  • University Medical Center Groningen
  • Groningen 9713 GZ Netherlands

View trial on ClinicalTrials.gov

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