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| Name | Class |
|---|---|
| Wageningen University and Research | OTHER |
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Previous research has shown that a higher fiber intake may have a beneficial effect on the intestinal health and improve the effectiveness of immunotherapy, but this is not certain. The objective of this double-blinded randomized clinical trial is to analyze, whether increased dietary fiber intake by patients with metastatic melanoma will increase the relative amount of Bifidobacterium, which in turn stimulates immune cell activity and improves the response to immunotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fiber intervention arm | Experimental | Dried chicory roots |
|
| Placebo arm | Placebo Comparator | iso-caloric placebo (rice-puffs) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dried chicory roots | Dietary Supplement | The dried chicory roots are implemented using a dosage of 22.5 gram/day resulting in 18.5 gram additional fibers a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| An increase in the relative abundance of Bifidobacterium in fecal samples. | The primary endpoint of this study is defined as a ≥5% (e.g. from 3% to 8%) increase in the relative abundance of Bifidobacterium in fecal samples between baseline (T0) and follow-up (T1) and significant differences between the experimental arm and the control arm. | From baseline (T0) to 3-4 weeks (T1) after start ICI |
| Measure | Description | Time Frame |
|---|---|---|
| Fecal microbiota composition | Study the baseline and on-treatment gut microbiota composition of patients with melanoma treated with ICI +/- additional dietary fiber. | Measurement at baseline (T0), 3-4 weeks (T1), 3-4 months (T2), and 6-7 months (T3) after start ICI |
| Radiological response rate to ICI |
| Measure | Description | Time Frame |
|---|---|---|
| Habitual dietary intake (Food Frequency Questionnaire) | Nutritional intake is measured using a semi-quantitative Food Frequency Questionnaire (FFQ). Scores are calculated using the Dutch National Food Consumption tables. The FFQ will be used to evaluate habitual diet and fiber intake. | At baseline (T0) and at 3-4 months (T2) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kalijn Bol, dr. | Contact | +31 243618800 | Kalijn.Bol@radboudumc.nl | |
| Isabel Ossekoppele, MS | Contact | Isabel.Ossekoppele@radboudumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Oncology | Nijmegen | Gelderland | 6525GA | Netherlands |
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The FIGURE-IM is a randomized, double-blind, placebo-controlled, phase II clinical trial with two-arms to assess the effect of dietary fiber supplementation on the gut microbiota in patients with metastatic melanoma. Participants will be stratified based on gender and standard-of-care ICI treatment (nivolumab/pembrolizumab or nivolumab + ipilimumab). In the experimental arm the participants will receive fiber rich dried chicory roots additional to the habitual diet while receiving standard-of-care ICI treatment (nivolumab/pembrolizumab or nivolumab + ipilimumab). The participants from the placebo/control arm receive rice puffs which contain a neglectable amount of fiber while receiving standard-of-care ICI treatment (nivolumab/pembrolizumab or nivolumab + ipilimumab). Participants will be randomized 1:1.
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|
| Placebo | Dietary Supplement | The control arm will receive 12.4 grams of placebo a day, isocaloric to the intervention. |
|
|
Evaluate radiological response rates to ICI +/- additional dietary fiber, assessed by CT/PET scan per RECIST 1.1 defined as; the date of randomization to the date of disease progression or death, respectively. |
| From baseline (T0) to the first date of documented progression or date of death from any cause, wichever came first, assesed up to 5 year. |
| Progression free survival (PFS) | Evaluate progression-free survival defined as; the date of randomization to the date of disease progression or death, respectively. | From baseline (T0) to the first date of documented progression or date of death from any cause, wichever came first, assesed up to 5 year. |
| Overall survival (OS) | Evaluate overall survival to ICI +/- additional dietary fiber defined as; the date from randomization to date of death, respectively. | From baseline (T0) on, survival follow-up will be continued after study completion for a maximal of 5 years in accordance with standard-of-care follow-up. |
| Evaluate the gastro-intestinal side effects of additional dietary fiber intake | Evaluate the gastro-intestinal side effects of additional dietary fiber intake, according to CTCAE common criteria v 5.0. | From start intervention at baseline (T0) until the end of wash-out period at 6-7 months (T3) after start ICI. |
| Physical activity level (Short QUestionnaire to ASsess Health-enhancing physical activity) |
Physical activity is measured using the Short QUestionnaire to ASsess Health-enhancing physical activity (SQUASH). The questions in the SQUASH are pre-structured in commuting, leisure time, household and work/school activities. Scores will be assigned to the different reported activities base on intensities in MET and translated to minutes of physical activity. |
| At baseline (T0) and at 3-4 months (T2) |
| Sleep quality and duration (Pittsburgh Sleep Quality Index) | Sleep quality is measured with the Pittsburgh Sleep Quality Index (PSQI), a 19-item questionnaire with scores ranging from 0-21. A score above 5 indicates bad sleep quality. | At baseline (T0) and at 3-4 months (T2) |
| Bristol Stool Scale (BSS) | Stool consistency is measured using the Bristol Stool Scale (BSS) | Measurement at baseline (T0), 3-4 weeks (T1), 3-4 months (T2), and 6-7 months (T3) after start ICI |
| Circulating tumor DNA (ctDNA) | ctDNA levels will be analysed to evaluate circulating tumor DNA. | Measurement at baseline (T0), 3-4 weeks (T1), 3-4 months (T2), and 6-7 months (T3) after start ICI |
| Short-Chain Fatty Acids | Fecal and Plasma SCFA's levels will be evaluated. | Measurement at baseline (T0), 3-4 weeks (T1), 3-4 months (T2), and 6-7 months (T3) after start ICI |
| Sequencing mRNA in circulating immune cells | (m)RNA will be sequenced to evaluate the transcription/gene expression in circulating immune cells. | Measurement at baseline (T0), 3-4 weeks (T1), 3-4 months (T2), and 6-7 months (T3) after start ICI |
| Tumor infiltration | Archived tumor tissue, previous to baseline (T0): Pre-interventional tumor tissue will be requested for immune cell analyses using multiplex immunohistochemistry. | Pretreatment |
| Universitair Medisch Centrum Groningen | Groningen | Provincie Groningen | 9713GZ | Netherlands |
|
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| ID | Term |
|---|---|
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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