The primary objective of this study is to investigate the effect of dried chicory root (WholeFiber) during 6 weeks on fecal SCFA levels in intermediate to high-risk melanoma patients after surgical treatment with no concurrent adjuvant treatment.…
ID
Source
Brief title
Condition
- Skin neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
- Food (substances)
N.a.
Outcome measures
Primary outcome
<p>Effect of a high fiber prebiotic vegetable (WholeFiber) for 6 weeks on fecal<br />
SCFA levels in intermediate to high-risk cutaneous melanoma patients, with no<br />
concurrent adjuvant treatment. HPLC ion chromatography system (Metrohm AG,<br />
Herisau, Switzerland) will be used to determine the levels of SCFA. The<br />
concentrations of SCFA; butyrate, propionate, and acetate will be measured with<br />
a conductivity detector. SCFA will be measured at baseline, halfway<br />
intervention and after 6 weeks. </p>
Secondary outcome
<p>Discovering the gut microbial composition changes measured in intermediate to<br />
high-risk cutaneous melanoma patients with no concurrent adjuvant treatment,<br />
after using WholeFiber for 6 weeks. This analysis will be based on whole genome<br />
sequencing of fecal samples performed at the UMCG according to standardized<br />
protocol.<br />
Exploring the effect of WholeFiber use for 6 weeks on immune functioning, stool<br />
patterns, fecal calprotectin levels and side effects in this patient group.<br />
Peripheral blood mononuclear cells (PBMCs) and bloodplasma will be isolated to<br />
be able to identify hypothesized changes in immune cell composition. Fecal<br />
calprotectin will be determined using the respective ELISA kit (Thermo Fisher<br />
Scientific). Calprotectin is released when neutrophils enter the gut wall and<br />
are activated during the inflammatory process. Lastly, eating patterns, fiber<br />
intake before the start of the studyperiod, stool patterns and side effects<br />
will be identified using<br />
- Food Frequency Questionnaire<br />
- Bristol Stool Scale<br />
- Gastrointestinal Symptoms Rating Scale<br />
- Health Related Quality of Life Questionnaire</p>
Background summary
After surgical treatment of an intermediate to high-risk cutaneous melanoma
(T3/T4), recurrence can take place within 5 years in around 30-50% of the
cases. The gut microbiome, consisting of bacteria and other microorganisms
living in the gut, has been identified as therapeutic target in patients with
stage IV melanoma treated with immune checkpoint inhibition. Interestingly, in
intermediate to high-risk cutaneous melanoma (minimal stage II A) very often
tumor infiltrating lymphocytes are found, which sometimes leads to spontaneous
remission of these tumors. Therefore, it can be beneficial to explore the gut
microbial composition and modulatory capacity of the gut microbiome in this
patient group to see whether the gut microbiome could play a role in
strengthening immune system functioning. Dietary fibers can modulate the gut
microbial composition, thereby favoring bacteria which are able to produce
short-chain fatty acids (SCFAs). These SCFAs are hypothesized to have a
beneficial effect on the immune cell composition, fecal calprotectin levels,
stool pattern and general well-being.
Study objective
The primary objective of this study is to investigate the effect of dried
chicory root (WholeFiber) during 6 weeks on fecal SCFA levels in intermediate
to high-risk melanoma patients after surgical treatment with no concurrent
adjuvant treatment.
Secondary objectives
• Analysis of the gut microbial composition of surgically treated intermediate
to high-risk cutaneous melanoma patients before intake and potential
compositional changes after using WholeFiber for 6 weeks.
• Exploration of the effect of WholeFiber use for 6 weeks on immune cell
composition, stool patterns, fecal calprotectin levels and side effects in
intermediate to high-risk cutaneous melanoma patients after surgical treatment,
with no concurrent adjuvant treatment.
Study design
This study will be an explorative study at the University Medical Center
Groningen (UMCG). All measurements, in detail described in chapter *8.3 - Study
procedures*, will be performed in all patients. The effect of oral intake of
dried chicory root (WholeFiber) in intermediate to high-risk cutaneous melanoma
after surgical treatment, with no concurrent adjuvant treatment, will be
tested. Inclusion of patients in the study can take place within 16 weeks after
surgery, the baseline visit (T0) can take place later than 16 weeks after surgery. This is in line with the exclusion criterium that patients can't use antibiotics in the 3 months prior tot inclusion. WholeFiber will be used by the patients for 6 weeks two times a day (10 g per portion). In the first week of the intervention WholeFiberTM will be used one time a day (10 g per portion) to let the study participants adjust to the product. The study consists of 4 visits, including the informed consent visit. The estimated visit time is 60 minutes, apart from the inclusion
visit which will take approximately 30 minutes.
Three timepoints are included in this study:
• Baseline (T0), where patients will collect a fecal sample at home, a blood
sample will be drawn, and patients will fill in questionnaires.
• Mid-Trial (T1), collection of a fecal sample at home, a blood sample will be
drawn, and patients will fill in questionnaires.
• End of Trial (T2), collection of a fecal sample at home, a blood sample will
be drawn, and patients will fill in questionnaires.
Intervention
Subjects will receive 2 sachets of 10 g WholeFiber per day for 6 weeks (equals
17 g fiber). In the first week the dose will be 10 g/day, to get used to the product.
Study burden and risks
WholeFiber is a dried vegetable (chicory root) that for 85% consists of
prebiotic fibers, safe for consumption and is commercially available.
Increasing dietary fiber intake is beneficial for overall health and may give
some abdominal complaints at the start of use. Patients will visit the study
site three times for blood tests and fecal samples will be collected at home.
Filling in questionnaires is also a burden.
G.A.P. Hospers
Hanzeplein 1
Groningen 9713 GZ
Netherlands
050-3612821
g.a.p.hospers@umcg.nl
G.A.P. Hospers
Hanzeplein 1
Groningen 9713 GZ
Netherlands
050-3612821
g.a.p.hospers@umcg.nl
Trial sites in the Netherlands
Listed location countries
Age
Inclusion criteria
• Age >=18 years;
• The participant understands the study and can provide written informed
consent;
• The participant received surgical treatment of an intermediate to high-risk
cutaneous melanoma (T2a, T2b, T3a, T3b, T4a, T4b, N0 or N+, M0, Stage IV with no evidence
of M+ disease);
• Being able to read and speak Dutch;
• Willing to come to the UMCG for practical reasons (visiting the study site);
• Willing to continue their regular lifestyle patterns during the study.
Exclusion criteria
• Receiving concurrent adjuvant treatment, adjuvant treatment after the study
period is allowed.
• Having a medical history that may impact study outcomes, such as a diagnosis
of diabetes mellitus type 2, heart disease, renal disease, autoimmune disease;
• Any clinically significant or unstable medical disorder involving the gut,
including celiac disease, inflammatory bowel disease, short-bowel syndrome or
acute/chronic pancreatitis;
• Having an ileostomy or colostomy, as this greatly impacts bowel function and
gut microbial composition;
• Use of antibiotics in the 3 months prior participation in the study;
• Use of prednisolone or other immunosuppressive medication;
• Use of tube feeding or sib-feeding;
• Being pregnant or lactating;
• Participation in another interventional study at the same time;
• Unable or unwilling to comply to study rules.
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
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 | NL86967.042.24 |
| Research portal | NL-005405 |