๐ฌIn plain words
What the trial is, and whether it could suit you
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 months and it occurs in 50-80% of patients with metastatic cancer.
It is estimated that CC is a direct cause of up to 30% of all cancer-related deaths. No treatment currently is available to prevent CC, likely because the chemical reactions that causes of this devastating phenomenon in unknown.
No treatment currently is available to prevent muscle mass loss in patients with cancer but is urgently needed as the reduced muscle mass and function is associated with impaired physical function, reduced tolerance to anticancer therapy, poor quality of life (QoL), and reduced survival. There is evidence of an interdependence between informal caregiver (e.g. spouse) and patient QoL. Thus, identifying
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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
University of Copenhagen
Copenhagen, Denmark
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.