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

NCT04528745 | Completed

• 1 other identifier: H-20000245
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (8)

• 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)

  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)

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

• Leucocyte count (per cycle - see outcome 1)

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

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

• Thrombocyte count (per cycle - see outcome 1)

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

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

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

  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)

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

• Neutropenia

  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)

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

• Febrile neutropenia

  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)

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

• Anemia

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

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

• Thrombocytopenia

  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)

  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 (2)

• Dose-limiting toxicity (DLT)

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

• Hospitalization

  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 (22)

• Overall health

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

• Overall quality of life

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

• Energy intake (per cycle - see outcome 1)

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

Study Arms (1)

Patients with cancer receiving cytostatic treatment

Consecutive patients referred for cytostatic treatment or in treatment with cytostatic agents for colorectal or pancreatic cancer

Diagnostic Test: Bio Impedance Spectroscopy (BIS)

Interventions

Bio Impedance Spectroscopy (BIS) DIAGNOSTIC_TEST

Determination of fat free mass by BIS

Patients with cancer receiving cytostatic treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Breastfeeding
• Dementia
• Contraindications for BIS measuring (pacemaker)

Sponsors & Collaborators

• University of Copenhagen: lead
• Zealand University Hospital: collaborator

Study Sites (1)

Zealand University Hospital

Roskilde, 4000, Denmark

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Colorectal Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Jens R Andersen

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: August 27, 2020
• Study Start: May 4, 2020
• Primary Completion: October 9, 2020
• Study Completion: November 30, 2020
• Last Updated: September 29, 2021

Record last verified: 2021-09

Locations

DK (1)