Clinical trial NCT04528745: The Relationship Between Fat Free Mass and Toxicity of Cytostatics in Cancer Patients
Official title: The Relationship Between Fat Free Mass and Toxicity of Cytostatics in Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreas Cancer
Colorectal Cancer
Keywords: cancer
chemotherapy
toxicity
lean body mass
cytostatics
fat free mass
dose-limiting toxicity
adverse events
adult
quality of life
nutrition
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Zealand University Hospital
First posted: 2020-08-27
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients at the department of Clinical Oncology at Zealand University Hospital, Roskilde, Denmark, who fulfills all inclusion criteria and none of the exclusion criteria.

Brief summary: 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.

Detailed description: With a prospective observational design, this study will examine whether there is a correlation between the total dose of cytostatics per measured fat-free mass (FFM) (mg cytostatic agent/kg FFM) and toxicity of cytostatics among cancer patients. The study will include patients with a primary diagnosis of any stage colorectal or pancreatic cancer.

The hypothesis is, that a higher total dose of cytostatics per FFM will correlate to more frequent and/or more severe toxicity than a lower total dose. In extension to this, we hypothesize that a loss of FFM during treatment, and thereby an increased total dose of cytostatics per FFM, will lead to more frequent and severe toxicity.

Recruitment and data collection will take place at the department of Clinical Oncology at Zealand University Hospital, Roskilde over about a five month period. Each patient will be included for two-four cycles of cytostatic treatment. FFM will be measured by bio impedance spectroscopy as close to the first day of each cycle of cytostatic treatment as possible. Information about toxicity will be obtained from patient records and through interviews with the patients. Interviews will be conducted at day 5 (4-6) of each cycle and at the end of each cycle. The interviews include questionnaires about specific toxicities, using National Cancer Institute (NCI) Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), and overall health and quality of life, and 24-hour recall of dietary intake and questions about physical activity level.

In short, relevant outcomes are change in FFM, hematology, grade 3/4 hematological toxicity as defined by NCI CTCAE, dose-limiting toxicity, hospitalization, patient-reported adverse events, overall health and quality of life, and nutritional intake.

Eligibility criteria: 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)

Primary outcomes:
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)
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)
measure: Thrombocyte 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)
measure: Mmol of haemoglobin/L (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)
measure: Neutropenia
timeFrame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)
measure: Febrile neutropenia
timeFrame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)
measure: Anemia
timeFrame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)
measure: Thrombocytopenia
timeFrame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)
Secondary outcomes:
measure: Dose-limiting toxicity (DLT)
timeFrame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)
measure: Hospitalization
timeFrame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)
Other outcomes:
measure: Overall health
timeFrame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)
measure: Overall quality of life
timeFrame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)
measure: Energy intake (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)
measure: Protein intake (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)
measure: Weight change (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)
measure: Difficulty swallowing
timeFrame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)
measure: Mouth/throat sores
timeFrame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)
measure: Taste changes
timeFrame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)
measure: Decreased appetite
timeFrame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)
measure: Nausea
timeFrame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)
measure: Vomiting
timeFrame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)
measure: Constipation
timeFrame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)
measure: Diarrhea
timeFrame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)
measure: Shortness of breath
timeFrame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)
measure: Rash
timeFrame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)
measure: Hair loss
timeFrame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)
measure: Hand-foot syndrome
timeFrame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)
measure: Numbness & tingling
timeFrame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)
measure: General pain
timeFrame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)
measure: Fatigue
timeFrame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)
measure: Nosebleed
timeFrame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)
measure: Other adverse event(s) added by patient
timeFrame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)
Locations:
city: Roskilde
country: Denmark
facility: Zealand University Hospital
Study officials:
affiliation: University of Copenhagen
name: Jens R Andersen
role: PRINCIPAL_INVESTIGATOR
References: