Colorectal Cancer
Conditions
Keywords
Dietary fiber, Postoperative complications, Surgery, Gut microbiota, Colorectal cancer, Prehabilitation
Brief summary
The aim of this randomized controlled trial is to investigate the feasibility of increasing preoperative dietary fiber intake in individuals with colorectal cancer who will undergo surgery. This will be done using 1) digital personalized dietary advice or 2) a dried vegetable product compared to 3) habitual diet (control).
Detailed description
Rationale: Postoperative complications, affecting up to 50% of the patients with colorectal cancer (CRC) undergoing surgery, are associated with impaired quality of life and higher mortality rates. The investigators have previously shown an association between a higher preoperative dietary fiber intake and a lower risk of postoperative complications. Before large interventions aiming to evaluate potential causal relationships between dietary fiber and postoperative complications can be implemented, feasibility of increasing dietary fiber intake before CRC surgery needs to be explored. Objective: To investigate the feasibility of increasing preoperative dietary fiber intake in CRC patients undergoing surgery via 1) personalized dietary advice (Vezel-UP tool), or 2) vegetable product containing natural fibers compared to 3) habitual diet (control group). Secondary objectives will be considered to generate preliminary (biological) data to support the design of a future large-scale intervention studies. Study design: A randomized controlled trial with three groups: 1) Vezel-UP group, 2) vegetable product group, and 3) control group. The intervention period equals the time between diagnosis and surgery, which is on average \ 4 weeks but will vary between individual patients depending on their characteristics (e.g., physical condition and tumor location) and waiting list. Study population: 54 CRC patients who will undergo elective tumor resection. Main study parameters/endpoints: The primary outcome is the change in dietary fiber intake, which is assessed via two 24hr dietary recalls at baseline and during and after the intervention. Secondary parameters are stool pattern, gastrointestinal symptoms, quality of life, fecal microbiota composition, fecal and plasma microbial metabolites levels (i.e., SCFA and indoles), and length of hospital stay.
Interventions
OTHERDietary intervention
Increase dietary fiber intake
Sponsors
Wageningen University
Gelderse Vallei Hospital
VLAG Graduate School
Alliance TU/e, WUR, UU, UMC Utrecht (EWUU)
Nutrition & Healthcare Alliance
WholeFiber BV
Wageningen Food and Biobased Research (WFBR)
Meander Medical Center
Rijnstate Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
A randomized controlled trial with three parallel arms consisting of two intervention arms and one control arm. Multicenter study conducted in collaboration with three participating hospitals, including Hospital Gelderse Vallei (Ede), Meander Medical Center (Amersfoort), and Rijnstate Hospital (Arnhem)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years; * Being diagnosed with CRC and planned to undergo elective CRC resection;
Exclusion criteria
* Previously have had a large abdominal resection, excluding appendectomy and cholecystectomy; * Diagnosed with Crohn's disease, Ulcerative Colitis, Celiac Disease; * Currently having a stoma; * Known allergic reactions to plants from the Asteraceae (Compositae) family (e.g., lettuce, daisies, sunflowers, artichokes, sage, tarragon, chamomile, chicory etc.); * Currently following a strict diet and unwilling or unable to change (e.g., gluten free or ketogenic diet); * Currently using fiber supplements, prebiotics and/or probiotics and unwilling to stop using these for the duration of the intervention; * Having a habitual dietary fiber intake \>30 g/day for women and \>40 g/day for men, measured with a food frequency questionnaire; * Dementia or other cognitive disabilities that makes it impossible to fill out questionnaires correctly; * Illiteracy (inability to read and understand Dutch).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dietary fiber intake | 3 time points: T0 (at baseline), T1 (after 2 weeks of intervention), and T2 (at the end of intervention period, on average after 4 weeks). | Change in dietary fiber intake is assessed via two 24hr dietary recalls. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stool pattern | 3 time points: T0 (at baseline), T1 (after 2 weeks of intervention), and T2 (at the end of intervention period, on average after 4 weeks). | Change in stool frequency per week and average stool consistency per week assessed using the Bristol Stool Chart. |
| Gastrointestinal symptoms | 3 time points: T0 (at baseline), T1 (after 2 weeks of intervention), and T2 (at the end of intervention period, on average after 4 weeks). | Change in gastrointestinal symptoms measured with the Gastrointestinal Symptom Rating Scale (GSRS). Higher scores mean a worse outcome. |
| Health-related quality of life | 3 time points: T0 (at baseline), T1 (after 2 weeks of intervention), and T2 (at the end of intervention period, on average after 4 weeks). | Change in quality of life measured with the European Organization for Research and Treatment for Cancer Quality of Life Questionnaire (EORTC QLQ-C30 \& CR29). Global and functional health-related quality of life will be calculated, for which higher scores indicate better quality of life. Also symptom scales will be calculated, for which higher scores indicate higher presence or severity of a symptom. |
| Fecal gut microbiota composition | 3 time points: T0 (at baseline), T1 (after 2 weeks of intervention), and T2 (at the end of intervention period, on average after 4 weeks). | Measured using 16S rRNA amplicon sequencing in fecal samples. |
| Fecal microbial metabolite levels | 3 time points: T0 (at baseline), T1 (after 2 weeks of intervention), and T2 (at the end of intervention period, on average after 4 weeks). | Change in SCFA and indole concentrations determined by GC-MS/MS and LC-MS/MS in fecal samples. |
| Plasma microbial metabolite levels | 2 time points: T0 (at baseline) and T2 (at the end of intervention period, on average after 4 weeks). | Change in SCFA and indole concentrations will be determined by GC-MS/MS and LC-MS/MS in blood samples. |
| Length of hospital stay | From date of surgery until date of hospital discharge, assessed up to 90 days after surgery. | Time between surgery and hospital discharge in number of days based on data from medical records. |
Countries
Netherlands
Outcome results
None listed