Clinical trial · Observational
The Relationship Between Fat Free Mass and Toxicity of Cytostatics in Cancer Patients
NCT04528745CI-TRIAL-00054154completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
An observational study of the relationship between fat free mass and toxicity of cytostatics in cancer patients, at the department of Clinical Oncology at Zealand University Hospital, Roskilde, Denmark. Fat free mass will be measured by bio impedance spectroscopy and data on toxicity will be obtained from medical records and interviews/questionnaires with the patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bio Impedance Spectroscopy (BIS) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with cancer receiving cytostatic treatment
- description
- Consecutive patients referred for cytostatic treatment or in treatment with cytostatic agents for colorectal or pancreatic cancer
- interventionNames
- Diagnostic Test: Bio Impedance Spectroscopy (BIS)
Primary outcomes (8)
- measure
- Change in fat free mass between cycles of cytostatic treatment (each cycle lasts for 14, 21 or 28 days, depending on the type of regime)
- timeFrame
- During and between two-four cycles, depending on regime (each cycle is 14, 21 or 28 days, depending on the regime)
- description
- Changes in fat free mass, measured at baseline and the beginning of each cycle, between cycles of cytostatic treatment, and correlation with dose of cytostatic agent (mg) pr. fat free mass (kg)
- measure
- Leucocyte count (per cycle - see outcome 1)
- timeFrame
- During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Authorized individuals * Understands, speaks and reads Danish * Patients referred for or who receives cytostatic treatment, and have a primary diagnosis of colorectal- or pancreatic cancer (diagnoses classified by International Classification of Diseases-10 as C18-21 and C25) * Have the possibility of contact by telephone Exclusion Criteria: * Pregnancy * Breastfeeding * Dementia * Contraindications for BIS measuring (pacemaker)
References
Publications (0)
Data not yet available
No reference posted for this study.