Status:
RECRUITING
Cancer-associated Muscle Mass - Molecular Factors and Exercise Mechanisms
Lead Sponsor:
University of Copenhagen
Collaborating Sponsors:
Rigshospitalet, Denmark
Conditions:
Cachexia
Neoplasms
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
Muscle mass loss is a common adverse effect of cancer. Muscle mass loss occurs with or without reduction in body weight. Cancer cachexia (CC) is the involuntary loss of body weight of \>5% within 6 mo...
Eligibility Criteria
Inclusion
- Inclusion Criteria, WP1+WP2X+WP2:
- Men and women at or above the age of 18
- Histological and radiological verified NSCLC (both squamous and adenocarcinoma) st. IIIb/IV stage not eligible to concurrent chemo/radiation therapy as primary treatment
- Referred for 1st line palliative anticancer therapy (platin based, immunotherapy, combined therapy or TKI), this goes for WP1 + WP2
- Referred for palliative anticancer therapy (platin based, immunotherapy, combined therapy or TKI), for recurrent cancer, this goes only for WP2X.
- Having a staging/baseline CT within 4 weeks of initiation of treatment (PET/CT are also allowed), or a baseline scan planned within the first week of treatment.
- ECOG Performance Status 0-2
- Having signed the informed consent form
- Exclusion Criteria, WP1+WP2X+WP2:
- Any other known malignancy requiring active treatment (prior cancer diagnosis is not some exclusion criteria if oncology-treatment is completed)
- Local palliative radiotherapy as primary treatment
- ECOG Performance status \> 2
- Physical disabilities excluding physical testing
- Inability to understand Danish
- Inability to understand scoring systems/patient-reported outcome measures
- Inclusion Criteria, WP3:
- Men and women above the age of 18
- Histological and radiological verified NSCLC (both squamous and adenocarcinoma) st. IIIb/IV stage
- ECOG Performance Status 0-2
- Having signed the informed consent form.
- Exclusion Criteria, WP3:
- Any other known malignancy requiring active treatment (prior cancer diagnosis is not some exclusion criteria if oncology-treatment is completed)
- ECOG Performance Status \> 2
- Physical disabilities excluding physical testing
- Inability to understand Danish
- Inability to understand scoring systems/patient-reported outcome measures
Exclusion
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT05307367
Start Date
April 1 2022
End Date
January 1 2028
Last Update
May 16 2022
Active Locations (1)
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1
University of Copenhagen
Copenhagen, DK, Denmark, 2100