Pancreas CancerNCT04528745
The Relationship Between Fat Free Mass and Toxicity of Cytostatics in Cancer Patients
An observational study of Pancreas Cancer and Colorectal Cancer, run by University of Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer, Colorectal Cancer
- What is being tested?
- Bio Impedance Spectroscopy (BIS)
- How many people
- 52 participants
- Where
- 1 siteDenmark
- Study dates
- 4 May 2020to 30 Nov 2020
- How long will I take part?
- 9 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Breastfeeding
- Dementia
- Contraindications for BIS measuring (pacemaker)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pancreas Cancer, Colorectal Cancer
- Being tested
- Bio Impedance Spectroscopy (BIS)
- Keywords
- cancer, chemotherapy, toxicity, lean body mass, cytostatics, fat free mass, dose-limiting toxicity, adverse events, adult, quality of life, nutrition
- Medical subject headings
- Pancreatic Neoplasms, Colorectal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio Impedance Spectroscopy (BIS)Diagnostic test
Determination of fat free mass by BIS
| Study group | Role | What they receive |
|---|---|---|
| Patients with cancer receiving cytostatic treatment | Consecutive patients referred for cytostatic treatment or in treatment with cytostatic agents for colorectal or pancreatic cancer Receives: Diagnostic Test: Bio Impedance Spectroscopy (BIS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
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).
Measured: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)
Hospitalization
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).
Measured: During two-four cycles, depending on regime (about eight-nine weeks), and within each cycle (each cycle is 14, 21 or 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start4 May 2020
- Primary completion9 Oct 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
- Target duration
- 9 Weeks
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Zealand University Hospital
- Responsible party
- Principal investigator, Jens Rikardt Andersen, University of Copenhagen
- Investigators
- Jens R Andersen, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528745
- Sponsor's protocol ID
- H-20000245
- Status last verified
- Sep 2021
- First submitted
- 28 Apr 2020
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Fat Free Mass and Toxicity of Cytostatics in Cancer Patients
- ClinicalTrials.gov ID
- NCT04528745
- Acronym / sponsor ID
- H-20000245
- Conditions
- Pancreas Cancer, Colorectal Cancer
- Keywords
- cancer, chemotherapy, toxicity, lean body mass, cytostatics, fat free mass, dose-limiting toxicity, adverse events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Zealand University Hospital
- Study start
- 4 May 2020 (actual)
- Primary completion
- 9 Oct 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with cancer receiving cytostatic treatment | – | Diagnostic Test: Bio Impedance Spectroscopy (BIS)Consecutive patients referred for cytostatic treatment or in treatment with cytostatic agents for colorectal or pancreatic cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnancy
- Breastfeeding
- Dementia
- Contraindications for BIS measuring (pacemaker)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bio Impedance Spectroscopy (BIS)Determination of fat free mass by BIS | Diagnostic test | Patients with cancer receiving cytostatic treatment |
Primary outcome
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)
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)
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)
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)
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)
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)
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)
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)
2 secondary outcomes
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens R Andersen principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Cancer and Colorectal Cancer, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: During and between two-four cycles, depending on regime (each cycle is 14, 21 or 28 days, depending on the regime)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.