The primary objective of this study is to investigate the association between changes of lean body mass and overall grade 2-4 toxicity during adjuvant chemotherapy in colon (or rectal) cancer patients.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter of this observational study is overall grade 2-4
treatment-related toxicity. All clinical parameters and data on colon cancer
outcome will be gathered from PLCRC (data management performed by the
Netherlands Cancer Registry (NCR)). Grade 2 toxicity will not be recorded in
the NKR+ database. In order to be able to obtain data on the occurrence of
grade 2-4 toxicity during adjuvant chemotherapy, the treating medical
oncologist has to document the toxicities very accurately. Subsequently, the
study team of PLCRC-PROTECT+ have to gather the grade 2-4 toxicity data from
the electronic patient files.
Furthermore, we will make use of *Electronic Patient Reported Outcomes* (ePRO)
to measure treatment toxicities. We send out short digital questionnaires, one
week after administration of every adjuvant chemotherapy cycle.
Secondary outcome
Secondary parameters of this observational study are: specific subgroups of
overall grade 2-4 treatment-related toxicity, total chemotherapy adherence and
adherence at each chemotherapy cycle, dose reductions with reason, drug delay
or premature ending of chemotherapy. Furthermore, PIFA levels, treatment
response (disease progression and recurrence) and quality of life data, during
and after chemotherapy will be secondary parameters.
All clinical parameters (except for toxicity data) and data on colon cancer
outcome will be gathered from the PLCRC observational cohort study and the NCR.
Background summary
Colon cancer is one of the most common types of cancer and only 62% of the
patient survive more than 5 years [IKNL, 2016]. In the adjuvant setting,
chemotherapy completion rates are not optimal and dose reductions are often
required because of treatment toxicities. Evidence is accumulating that lean
body mass (LBM), which can be influenced by dietary intake and physical
activity, is related to treatment toxicity, but precise associations are yet
unknown. To date, little is known about the role of nutrition and lifestyle on
LBM in colon cancer patients, and how this will develop during adjuvant
chemotherapy regimens.
Since no studies have been performed so far, this prospective study in adjuvant
chemotherapy-receiving colon cancer patients is warranted to investigate if
changes in LBM occur, which factors can contribute to changes in LBM and how
this affects treatment toxicities, recurrence and survival.
Study objective
The primary objective of this study is to investigate the association between
changes of lean body mass and overall grade 2-4 toxicity during adjuvant
chemotherapy in colon (or rectal) cancer patients.
Study design
The PLCRC-PROTECT+ study is an observational study.
Study burden and risks
By participating in this observational study, patients will contribute to
scientific research on the impact of modifiable lifestyle factors and LBM on
colon cancer outcome. This study will provide insight into the evolution of LBM
throughout adjuvant chemotherapy and how modifiable risk factors can
contribute. The aim is to find factors that are associated with overall grade
(and subgroups of) 2-4 toxicities during adjuvant chemotherapy in colon cancer
patients.
For the PLCRC-PROTECT+ study, three blood samples will be taken in a period of
approximately 10 months. For patients included and treated in the UMCU a total
of six blood samples will be drawn. This amount of samples is compatible with
the obtained IC in the PLCRC cohort, where we ask the patient for IC to draw
blood samples on multiple time points with a maximum of 10 tubes of 10ml per
patient per year at non-predetermined moments during routine blood withdrawals.
For all these study-related blood samples the patient will already be in the
hospital and the patient does not need an extra venepuncture. Depending on the
hospital*s daily practice, the patient will get one or two extra CT-scans for
study purposes. Every patient will at least get one extra CT-scan during
adjuvant chemotherapy. Furthermore, depending on the hospital*s policy whether
to use ultrasound or CT for follow-up imaging, we either use the follow-up
CT-scan or an extra CT-scan will be made for study purposes after chemotherapy,
during the first follow-up only. After this study-related follow-up CT-scan,
the hospital will continue to use its normal follow-up policy.
To measure treatment-toxicities accurately, we will make use of *Electronic
Patient Reported Outcomes* (ePRO). We send out a short digital questionnaire,
two weeks after administration of every adjuvant chemotherapy cycle. Every
patient can receive a maximum of eight cycles of chemotherapy, so the maximum
time-investment will be (eight times five minutes) 40 minutes. Since grade 2-4
treatment toxicity is the primary outcome of the study, it is essential that we
take into account all scientific recommendations for accurately measuring
toxicity data, and therefore use patient-reported data collection.
The only risk associated by participating in this observational study is
related to the radiation from one to two extra CT-scans added to the clinical
routine CT. The radiation committee of the UMCU concluded that the use of
ionising radiation in the context of the study is warranted. A letter of
approval is separately added to this protocol. Other measurements do not induce
extra health risks in this study.
Heidelberglaan 100
Utrecht 3508 GA
NL
Heidelberglaan 100
Utrecht 3508 GA
NL
Listed location countries
Age
Inclusion criteria
- Age >=18.
- Histological confirmed colon cancer, (high risk stage II or stage III*), or rectal cancer.
- Colon or rectal (rectosigmoid, treated as colon) cancer patients who will receive adjuvant chemotherapy.
- Signed informed consent for participation in the PLCRC study (including informed consent for the collection of blood samples, invitation to future research and filling in questionnaires).
- Signed informed consent for the PLCRC-PROTECT study.
- Signed informed consent for the PLCRC-PROTECT+ study.
Exclusion criteria
- Non Dutch speaking patients.
- Mentally incompetent patients.
- Patients that receive(d) neo-adjuvant chemotherapy
- Patients who received one or more cycles of systemic therapy in the past 6 months.
- Pregnant or lactating women.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL57839.041.16 |