Acronym
PLCRC-PROTECT-PLUS
Name of the study
The PLCRC-PROTECT-Plus study: lean body mass and treatment toxicities in adjuvant chemotherapy-receiving colon cancer patients
Researchers and contact information
Contact information Project Manager
Dr. H.W.G. (Jeroen) Derksen, Postdoctoral researcher
Julius Center for Health Sciences and Primary Care
UMC Utrecht
PO Box 85500 (mailroom Str. 6.131), 3508 GA Utrecht
Email: h.w.g.derksen-2@umcutrecht.nl
Contact information Principal Investigator
Prof. dr. M. (Miriam) Koopman, Medical oncologist
Dept. of Medical Oncology
UMC Utrecht
PO Box 85500 (mailroom Q05.4.300), 3508 GA Utrecht
Email: m.koopman-6@umcutrecht.nl
Prof. dr. A.M. (Anne) May, Epidemiologist
Julius Center for Health Sciences and Primary Care
UMC Utrecht
PO Box 85500 (mailroom Str. 6.131), 3508 GA Utrecht
Email: a.m.may@umcutrecht.nl
Study team
06-46919566
Website
Summary study
Rationale: In the adjuvant setting, chemotherapy completion rates are not optimal and dose reductions are often required because of treatment-related toxicities. Evidence is accumulating that body composition (BC), specifically lean body mass, which can be influenced by diet and physical activity, is related to the severity of treatment-related toxicities. However, more insight in the role of diet, nutrition, and lifestyle on BC in colon cancer patients during (adjuvant) chemotherapy regimens is needed. This study investigates whether changes in BC occur, which factors contribute to changes in BC, and how this affects treatment toxicities, recurrence and survival.
Objective: The primary objective of this study is to investigate the association between changes in BC and overall grade 2-4 toxicity in patients with colon cancer who receive adjuvant chemotherapy.
Study design: The PLCRC-PROTECT-Plus study is an observational study.
Study population: Patients participating in PLCRC and the PLCRC-PROTECT study with colon cancer who receive adjuvant chemotherapy can be included.
Study procedures: BC will be measured using computed tomography (CT) images. We will determine BC at multiple time points throughout the treatment, namely; at diagnosis, halfway adjuvant chemotherapy (cycle 4), and after completion of adjuvant chemotherapy. In all patients, blood samples will be taken before cycle 1, before cycle 4 and post-chemotherapy to study the evolution of platinum-induced fatty acids in the blood (and other markers of interest, including nutritional status-, inflammation-, and cancer-related markers). Finally, treatment-related toxicities will be measured by sending short digital questionnaires two weeks after every administered chemotherapy cycle.
Main study parameters/endpoints: The main endpoint of this observational cohort study is overall grade 2-4 treatment-related toxicity. Both clinician-reported (electronic patient files) and patient-reported toxicity data will be collected.
Intervention
Participating centers
- UMC Utrecht
- Flevo Ziekenhuis, Almere
- Diakonessenhuis, Utrecht