Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Trial outcome index score (TOI) |
TOI |
Date of inclusion (baseline), day -2 and +7 at each chemotherapy (CT) in triweekly cycles/-2 days at each CT in weekly cycles and +7 after the last weekly CT, 4 months after inclusion, 3 weeks after end of CT and 1, 2 and 3 years after inclusion |
|
Other |
Total AC (FACT-B/FACT-O) |
According to kind of cancer (breast cancer/ ovarian cancer) |
Date of inclusion (baseline), day -2 and +7 at each CT in triweekly cycles/-2 days at each CT in weekly cycles and +7 after the last weekly CT, 4 months after inclusion, 3 weeks after end of CT and 1, 2 and 3 years after inclusion |
|
Other |
FACIT-F |
Fatigue |
Date of inclusion (baseline), day -2 and +7 at each CT in triweekly cycles/-2 days at each CT in weekly cycles and +7 after the last weekly CT, 4 months after inclusion, 3 weeks after end of CT and 1, 2 and 3 years after inclusion |
|
Other |
FACT-Tax,FACT/GynecologicOncologyGroup-Ntx |
Specific chemotherapy induced effects on quality of life and neurologic symptoms |
Date of inclusion (baseline), day -2 and +7 at each CT in triweekly cycles/-2 days at each CT in weekly cycles and +7 after the last weekly CT, 4 months after inclusion, 3 weeks after end of CT and 1, 2 and 3 years after inclusion |
|
Other |
Chemotherapy-Induced Peripheral Neuropathy Assessment Tool |
Chemotherapy-Induced Peripheral Neuropathy Assessment Tool |
Date of inclusion (baseline), day -2 and +7 at each CT in triweekly cycles/-2 days at each CT in weekly cycles and +7 after the last weekly CT, 4 months after inclusion, 3 weeks after end of CT and 1, 2 and 3 years after inclusion |
|
Other |
Hospital Anxiety and Depression Scale |
Hospital Anxiety and Depression Scale |
Date of inclusion (baseline), day -2 and +7 at each CT in triweekly cycles/-2 days at each CT in weekly cycles and +7 after the last weekly CT, 4 months after inclusion, 3 weeks after end of CT and 1, 2 and 3 years after inclusion |
|
Other |
Side effects of CT |
Likert scales |
Date of inclusion (baseline), day -2 and +7 at each CT in triweekly cycles/-2 days at each CT in weekly cycles and +7 after the last weekly CT, 4 months after inclusion, 3 weeks after end of CT and 1, 2 and 3 years after inclusion |
|
Other |
Weight |
Documentation according to the standard documentation rules of the German Tumour Centres Work Group, Weight in kilograms |
Timing varies according to individual therapy plan, Date of inclusion (baseline) and up to 3 years after inclusion |
|
Other |
BMI |
Documentation according to the standard documentation rules of the German Tumour Centres Work Group, BMI in kg/m^2 |
Timing varies according to individual therapy plan, Date of inclusion (baseline) and up to 3 years after inclusion |
|
Other |
Blood panel |
Documentation according to the standard documentation rules of the German Tumour Centres Work Group, units auf measure according to SI units |
Timing varies according to individual therapy plan, Date of inclusion (baseline) and up to 3 years after inclusion |
|
Other |
Blood values for liver function |
Documentation according to the standard documentation rules of the German Tumour Centres Work Group, units auf measure according to SI units |
Timing varies according to individual therapy plan, Date of inclusion (baseline) and up to 3 years after inclusion |
|
Other |
Blood values for renal function (Krea, Hst.) |
Documentation according to the standard documentation rules of the German Tumour Centres Work Group, units auf measure according to SI units |
Timing varies according to individual therapy plan, Date of inclusion (baseline) and up to 3 years after inclusion |
|
Other |
IGF-1, Insulin, Blood glucose |
Explorative measurements in blood samples in subgroup of 20 patients |
Baseline, after 4 months and before each of the first 4 CTs meaning approx week 1,4,7 and 10 after intervention start |
|
Other |
Long-term explorative measurements: frequency of recurrence |
Information taken from the documentation of the treatment, visits and questionnaires |
1, 2 and 3 years after baseline |
|
Other |
Long-term explorative measurements: e.g. polyneuropathy, cardiomyopathy |
Information taken from the documentation of the treatment, visits, questionnaires and interview |
1, 2 and 3 years after baseline |
|
Other |
ketone bodies |
Explorative measurements in capillary blood, only in subpopulation of n=20 |
Baseline, after 4 months and before each of the first 4 CTs meaning approx week 1,4,7 and 10 after intervention start |
|
Other |
Elective items of the "Common Terminology Criteria for Adverse Events (CTCAE) |
Elective items of the "Common Terminology Criteria for Adverse Events (CTCAE)" |
Baseline, 3 weeks after end of CT, 1,2,3 years after baseline |
|
Other |
Qualitative interviews in focus groups |
Qualitative interviews in focus groups |
Baseline, 6 months |
|
Primary |
FACT-G |
Summarized change of FACT-G score |
Date of inclusion (baseline), day -2 and +7 at each chemotherapy (CT) in triweekly cycles/-2 days at each CT in weekly cycles and +7 after the last weekly CT, 4 months after inclusion, 3 weeks after end of CT and 1, 2 and 3 years after inclusion |
|
Secondary |
Complete remissions |
Number of histologically proven complete remissions (ypT0ypN0 bzw. ypT0/is) after neoadjuvant CT |
From date of randomization until the date of surgery |
|
Secondary |
Millar Payne classification |
Histological classification according to Millar Payne scale |
after surgery/histological examination, an average 6 months after intervention start |
|