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Completed

NCT Number: NCT04528745

The Relationship Between Fat Free Mass and Toxicity of Cytostatics in Cancer Patients

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.

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Key information

Conditions

Pancreas Cancer Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zealand University Hospital

Roskilde, 4000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Bio Impedance Spectroscopy (BIS)

Diagnostic Test

Determination of fat free mass by BIS

Primary outcomes

  1. 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)

    Time frame: During and between two-four cycles, depending on regime (each cycle is 14, 21 or 28 days, depending on the regime)

    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)

  2. Leucocyte count (per cycle - see outcome 1)

    Time frame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)

    Correlation between change i absolute and relative leucocyte count from baseline, and total dose of cytostatic agent (mg) pr. fat free mass (kg)

  3. Thrombocyte count (per cycle - see outcome 1)

    Time frame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)

    Correlation between change i absolute and relative thrombocyte count from baseline, and total dose of cytostatic agent (mg) pr. fat free mass (kg)

  4. Mmol of haemoglobin/L (per cycle - see outcome 1)

    Time frame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)

    Correlation between change i absolute and relative mmol of haemoglobin/L from baseline, and total dose of cytostatic agent (mg) pr. fat free mass (kg)

  5. Neutropenia

    Time frame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)

    Correlation between incidence of absolute neutrophilic granulocyte count <1.0 - 0.5 x 10e9/L and total dose of cytostatic agent (mg) pr. fat free mass (kg)

  6. Febrile neutropenia

    Time frame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)

    Correlation between incidence of absolute neutrophilic granulocyte count <1.0 x 10e9/L, with a single temperature of >38.3 degrees C or a temperature of >= 38 degrees C lasting for more than one hour, and total dose of cytostatic agent (mg) pr. fat free mass (kg)

  7. Anemia

    Time frame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)

    Correlation between incidence of haemoglobin <4,9 mmol/L(; transfusion indicated) and total dose of cytostatic agent (mg) pr. fat free mass (kg)

  8. Thrombocytopenia

    Time frame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)

    Correlation between incidence of absolute thrombocyte count <50.0 - 25.0 x 10e9 /L and total dose of cytostatic agent (mg) pr. fat free mass (kg)

Secondary outcomes

  1. Dose-limiting toxicity (DLT)

    Time frame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)

    Correlation between DLT and total dose of cytostatic agent (mg) pr. fat free mass (kg).

    DLT is defined as toxicity leading to one or more of the following: Dose reduction of one or more cytostatic agent(s) (recorded as mg and %). Postponement of cytostatic therapy (recorded as number of days). Discontinuation of cytostatic therapy before scheduled.

    Causes of DLT (that are registered in patients records) are classified in one or more of the following categories: Infection, organ impact, myelosuppression, gastrointestinal discomfort, neuropathy or other toxicity (which one is recorded).

  2. Hospitalization

    Time frame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)

    Hospitalization note in patient record. Correlation between incidence and number of days of hospitalization and total dose of cytostatic agent (mg) pr. fat free mass (kg).

Other outcomes

  1. Overall health

    Time frame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)

    Correlation between overall health, and change therein, the first 5 (4-6) days of a cycle or the last week of a cycle, evaluated on a 7-point scale, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

  2. Overall quality of life

    Time frame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)

    Correlation between overall quality of life, and change therein, the first 5 (4-6) days of a cycle or the last week of a cycle, evaluated on a 7-point scale, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

  3. Energy intake (per cycle - see outcome 1)

    Time frame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)

    Correlation between relative fulfilment of energy requirement, and change therein, on day 5 (4-6) of a cycle or the last day of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg), and change in fat free mass (kg). Energy requirement is estimated by Harris-Benedict formula, including among other assessment of physical activity level. Energy intake is assessed by 24-hour recall of nutrition intake.

  4. Protein intake (per cycle - see outcome 1)

    Time frame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)

    Correlation between relative fulfilment of protein requirement, and change therein, on day 5 (4-6) of a cycle or the last day of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg), and change in fat free mass (kg). Protein requirement is estimated from the Danish Health Authority´s recommendation for adult patients. Protein intake is assessed by 24-hour recall of nutrition intake.

  5. Weight change (per cycle - see outcome 1)

    Time frame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)

    Correlation between relative and absolute weight change, measured at the beginning of each cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg), and change in fat free mass (kg).

  6. Difficulty swallowing

    Time frame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)

    Correlation between patient reported severity and interference with daily activities of difficulty swallowing on a 5-point scale, and change therein, the last week of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

  7. Mouth/throat sores

    Time frame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)

    Correlation between patient reported severity and interference with daily activities of mouth/throat sores on a 5-point scale, and change therein, the last week of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

  8. Taste changes

    Time frame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)

    Correlation between patient reported severity of taste changes on a 5-point scale, and change therein, the last week of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

  9. Decreased appetite

    Time frame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)

    Correlation between patient reported severity and interference with daily activities of decreased appetite on a 5-point scale, and change therein, the first 5 (4-6) days of a cycle or the last week of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

  10. Nausea

    Time frame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)

    Correlation between patient reported frequency and severity of nausea on a 5-point scale, and change therein, the first 5 (4-6) days of a cycle or the last week of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

  11. Vomiting

    Time frame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)

    Correlation between patient reported frequency and severity of vomiting on a 5-point scale, and change therein, the first 5 (4-6) days of a cycle or the last week of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

  12. Constipation

    Time frame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)

    Correlation between patient reported severity of constipation on a 5-point scale, and change therein, the last week of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

  13. Diarrhea

    Time frame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)

    Correlation between patient reported frequency of diarrhea on a 5-point scale, and change therein, the first 5 (4-6) days of a cycle or the last week of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

  14. Shortness of breath

    Time frame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)

    Correlation between patient reported severity and interference with daily activities of shortness of breath on a 5-point scale, and change therein, the last week of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

  15. Rash

    Time frame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)

    Correlation between patient reported incidence of rash (yes/no), and change therein, of the last week of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

  16. Hair loss

    Time frame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)

    Correlation between patient reported degree of hair loss on a 5-point scale, and change therein, the last week of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

  17. Hand-foot syndrome

    Time frame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)

    Correlation between patient reported severity of hand-foot syndrome on a 5-point scale, and change therein, the last week of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

  18. Numbness & tingling

    Time frame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)

    Correlation between patient reported severity and interference with daily activities of numbness and tingling on a 5-point scale, and change therein, the first 5 (4-6) days of a cycle or the last week of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

  19. General pain

    Time frame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)

    Correlation between patient reported frequency, severity and interference with daily activities of general pain on a 5-point scale, and change therein, the first 5 (4-6) days of a cycle or the last week of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

  20. Fatigue

    Time frame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)

    Correlation between patient reported severity and interference with daily activities of fatigue on a 5-point scale, and change therein, the last week of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

  21. Nosebleed

    Time frame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)

    Correlation between patient reported frequency and severity of nosebleed on a 5-point scale, and change therein, the last week of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

  22. Other adverse event(s) added by patient

    Time frame: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)

    Correlation between patient reported severity of adverse event(s) on a 5-point scale, and change therein, the first 5 (4-6) days of a cycle or the last week of a cycle, and total dose of cytostatic agent (mg) pr. fat free mass (kg).

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Zealand University Hospital

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 27, 2020
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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