Advanced pancreatic cancer patients
Conditions
Interventions
Group 1: Intervention Group
Observation Period (8 weeks), Follow-Up Period (16 weeks).
Baseline assessment at visit 1.
Physical activity, nutrition and pain management which will be adapted every two
Sponsors
Universitätsmedizin Mainz
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with histologically confirmed, previously untreated, unresectable (locally advanced or metastatic) advanced pancreatic cancer ductal adenocarcinoma (PDAC) 2. Eastern Cooperative Oncology Group (ECOG) performance status (PS): = 2 3. Patients with measurable or evaluable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria 4. Scheduled for combination chemotherapy (e.g., Gem-Abraxane or FOLFIRINOX) 5. Age = 18 years 6. Designated physical activity partner 7. Signed and dated informed consent form 8. Valid registration in a national health care system 9. Adequate bone marrow, liver and renal function 10. Participants of other clinical studies will be eligible for the study if the primary endpoints of both studies do not overlap. 11. Subject is able to comply with all study procedures. 12. Patient willing and able to give informed consent for participation in the study. 13. Patient should have a smartphone and agree to use it for the purposes of the study
Exclusion criteria
Exclusion criteria: 1. Cardiovascular, respiratory, psychiatric, musculoskeletal, or neurological condition contraindicating physical exercise 2. Endocrine or acinar pancreatic carcinoma 3. Active cerebral metastases, a history of another active major cancer 4. Active infection 5. Chronic diarrhea 6. Clinically significant history of cardiac disease 7. Pregnancy or breast-feeding 8. Legal incapacity or limited legal capacity 9. Subjects which present, in the opinion of the Investigator, a reduced cognitive function (such as dementia) or technological illiteracy and are not able to provide reliable information to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of Life assessed by the EORTC-QLQ-C30. | — |
Secondary
| Measure | Time frame |
|---|---|
| Includes assessment of the effects of the multimodal intervention between baseline and eight (8) weeks intervention/ sixteen (16) weeks follow-up and between the arms for the following parameters: - Pain (PDI, Pain-NRS) - Nutrition (SEFI, PG-SGA, PG-SGA-SF, PERT check) - Physical Activity (IPAQ-SF, 6MWT, FTSST, HGST, BBT) - Fatigue (Fatigue VAS) - Sarcopenia (Sarcopenia Index, SARC-F) - Social Impact and digital tools usability (Social Impact Questionnaire) - Burden Scale for Family Caregiver (BSFC-SF) | — |
Countries
Estonia, Germany, Israel
Contacts
Public ContactGabrielle Oestreicher
Universitätsmedizin Mainz
Outcome results
None listed