Effekt af MKS på kolorektal cancerpatienter (FCRC22)
10. juni 2026 opdateret af: Changhong Miao, Fudan University
Effekt af perioperativ diætrestriktionsstrategi på postoperativ restitution og resultater af patienter med kolorektal cancer: en multicenter prospektiv, randomiseret, kontrolleret undersøgelse
Omfattende prækliniske beviser tyder på, at kortvarige faste- og faste-efterlignende diæter (FMD'er) kan beskytte raske celler og gøre kræftceller mere sårbare over for kemoterapi og andre terapier.
Faste er dog svært for de gamle og skrøbelige forsøgspersoner. Derfor kan MKS'er være mere velegnede til postoperativ diætintervention hos cancerpatienter.
Kolorektale tumorer har et højt glukoseforbrug, hvilket gør tumorceller meget følsomme over for ændringer i ernæringsmetabolismen i det omgivende miljø (såsom diætbegrænsning/faste).
Tidligere undersøgelser har vist, at cykliske mund- og klovsyge er sikre og mulige for kræftpatienter, der får kemoterapi alene.
Virkningerne af mund- og klovsyge hos patienter under radikal kirurgi for tyktarmskræft er dog endnu ikke blevet evalueret.
Denne undersøgelse har til formål at evaluere virkningen af mund- og klovsyge på postoperativ genopretning og resultater af patienter med kolorektal cancer.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
602
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kina, 200032
- Fudan University Shanghai Cancer Center
-
Shanghai, Shanghai Municipality, Kina, 200032
- Fudan University Huashan Hospital
-
Shanghai, Shanghai Municipality, Kina, 200032
- Fudan University,ZhongShan Hospital
-
Shanghai, Shanghai Municipality, Kina, 200032
- Shanghai Changhai Hospital, Naval Medical University,
-
Shanghai, Shanghai Municipality, Kina, 200032
- Shanghai First People's Hospital,Shanghai Jiaotong University
-
Shanghai, Shanghai Municipality, Kina, 200032
- Shanghai Tongji Hospital,Tongji University
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Alder 18-80 år
- Patienter, der for første gang gennemgår radikal kolorektal cancerresektion
- Præoperativ klinisk tumor stadium III
- ASA grad I-III klasse
- Med BMI 19-32 kg/m2
- Tilstrækkelig leverfunktion, tilstrækkelig nyrefunktion og normal hjertefunktion
- Er villig til at deltage i forskningen af emnet og indvilliger i at følge op løbende
Ekskluderingskriterier:
- Bevis på fjernmetastaser før operation
- Inden operation har modtaget behandling af neoadjuverende kemoterapi
- Type 1 diabetes eller intensiv insulinbehandling
- Allergi for MKS-indhold
- Kombineret med alvorlige primære sygdomme såsom alvorligt immunsystem eller autoimmunsystem eller langvarig brug af glukokortikoider eller immunsuppressiva
- Anamnese med opioidmisbrug, psykisk sygdom eller kognitiv svækkelse
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Fastende efterlignende diæt
Den cykliske MKS-diæt består af en 5-dages kur: Dag 1 diæt af diæten leverer ~1000 kcal (10 % protein, 56 % fedt, 34 % kulhydrat), dag 2-5 er identiske i formuleringen og giver 800 kcal (9 % protein, 44% fedt, 47% kulhydrat).
Der udføres mindst 4 cykliske MKS'er efter operationen.
|
Den fastende efterlignende diæt består af en 5-dages kur: dag 1 diæt af diæten leverer ~1000 kcal (10% protein, 56% fedt, 34% kulhydrat), dag 2-5 er identiske i formuleringen og giver 800 kcal (9% protein, 44% fedt, 47% kulhydrat).
Der udføres mindst 4 cykliske MKS'er efter operationen.
|
|
Ingen indgriben: almindelig kost
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Disease-free Survival
Tidsramme: 3 years
|
DFS is defined as the time from randomisation to the first occurrence of locoregional recurrence, distant metastasis, or death from any cause, whichever occurs first.
The data of participants without an event will be censored at the date of the last follow-up.
Follow-up of survival will be conducted at least every 3 months beginning at 6 months after surgery.
Postoperative recurrence or metastasis will be determined on the basis of imaging studies, endoscopic examination, or histopathological assessment of biopsy specimens, with a review also performed by an expert panel.
|
3 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival
Tidsramme: 3 years
|
OS is defined as the time from randomisation to death from any cause.
The data of participants who are alive at the end of follow-up will be censored at the date of the last follow-up.
|
3 years
|
|
Weight and BMl
Tidsramme: Dietary intervention phase (up to 4 months) and 6 months after surgery
|
Weight will be measured to the nearest 0.1 kg using a calibrated electronic scale.
Measurements will be performed in the morning after an overnight fast and voiding, with participants in light clothing and without shoes.
Height will be measured to the nearest 1 cm without shoes.
BMI is calculated as weight divided by height squared (kg/m²).
Measurements will be performed before surgery, after surgery, and at 1, 2, 3, 4 and 6 months.
|
Dietary intervention phase (up to 4 months) and 6 months after surgery
|
|
upper arm circumference and waist circumference
Tidsramme: Dietary intervention phase (up to 4 months) and 6 months after surgery
|
Upper arm circumference and waist circumference will be measured to the nearest 0.1 cm using a non-stretchable tape, in the morning after an overnight fast and with the arms abducted to horizontal.
Measurements will be performed before surgery, after surgery, and at 1, 2, 3, 4 and 6 months.
|
Dietary intervention phase (up to 4 months) and 6 months after surgery
|
|
plasma albumin
Tidsramme: Dietary intervention phase (up to 4 months) and 6 months after surgery
|
Plasma albumin concentration will be measured in the morning after an overnight fast by accredited clinical laboratories, with results reported in g/L.
Measurements will be performed before surgery, after surgery, and at 1, 2, 3, 4 and 6 months.
|
Dietary intervention phase (up to 4 months) and 6 months after surgery
|
|
Nutritional status
Tidsramme: Dietary intervention phase (up to 4 months) and 6 months after surgery
|
Nutritional status will be assessed using the Patient-Generated Subjective Global Assessment (PG-SGA) score.
Higher scores (0-53 scale) indicate a worse nutritional status.
Assessments will be performed before surgery, after surgery, and at 1, 2, 3, 4 and 6 months.
|
Dietary intervention phase (up to 4 months) and 6 months after surgery
|
|
Quality of life (QOL)
Tidsramme: Dietary intervention phase (up to 4 months) and 6 months after surgery
|
QoL will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).
Higher total scores for the level 4 rating items, on a scale of 0-112, indicate a worse QoL.
Assessments will be performed before surgery, after surgery, and at months 1, 2, 3, 4 and 6 months.
|
Dietary intervention phase (up to 4 months) and 6 months after surgery
|
|
Exercise tolerance
Tidsramme: Dietary intervention phase (up to 4 months) and 6 months after surgery
|
Exercise tolerance will be assessed using metabolic equivalent of task (MET) values.
The MET values will be derived from patient-reported daily physical activities and with reference to the 2011 Compendium of Physical Activities Higher scores (1-23 scale) indicate a better exercise tolerance.
Assessments will be conducted before surgery, after surgery, and at months 1, 2, 3, 4 and 6 months.
|
Dietary intervention phase (up to 4 months) and 6 months after surgery
|
|
Chemotherapy-related toxicities
Tidsramme: within 2 weeks after each chemotherapy cycle
|
In participants receiving postoperative adjuvant chemotherapy, chemotherapy-related toxicities, including haematological, gastrointestinal, neurological and other adverse events, will be recorded after each chemotherapy cycle and graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
|
within 2 weeks after each chemotherapy cycle
|
|
insulin-like growth factor 1 (IGF-1)
Tidsramme: 4 months
|
IGF-1 will be measured in the morning after an overnight fast by accredited clinical laboratories, with results reported in ng/mL.
Measurements will be conducted before surgery, after surgery, and after dietary intervention .
|
4 months
|
|
Fasting serum glucose (FG)
Tidsramme: 4 months
|
FG will be measured in the morning after an overnight fast by accredited clinical laboratories, with results reported in mmol/L.
Measurements will be conducted before surgery, after surgery, and after dietary intervention.
|
4 months
|
|
Fasting insulin (FI)
Tidsramme: 4 months
|
FI will be measured in the morning after an overnight fast by accredited clinical laboratories, with results reported in uU/mL.
Measurements will be conducted before surgery, after surgery, and after dietary intervention.
|
4 months
|
|
C-peptide
Tidsramme: 4 months
|
C-peptide will be measured in the morning after an overnight fast by accredited clinical laboratories, with results reported in ng/mL.
Measurements will be conducted before surgery, after surgery, and after dietary intervention.
|
4 months
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Safety outcome
Tidsramme: Dietary intervention phase (up to 4 months)
|
Safety will be assessed in participants following at least one administration of the FMD regimen.
Adverse events occurring during the intervention period will be recorded at each follow-up contact and graded according to CTCAE v5.0.
The investigators will assess the severity of each event and its potential relationship with FMD intervention.
Safety outcomes will include the frequency and severity of FMD-related adverse events.
Predefined FMD-related adverse events include headache, weakness, fatigue, hunger, gastrointestinal symptoms, hypoglycemia, electrolyte abnormalities, and clinically significant weight loss.
|
Dietary intervention phase (up to 4 months)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Miaomiao Guo, Dr, Shanghai Zhongshan Hospital
- Ledende efterforsker: Meilin Weng, PhD, Shanghai Zhongshan Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
8. juni 2022
Primær færdiggørelse (Anslået)
30. oktober 2027
Studieafslutning (Anslået)
30. oktober 2027
Datoer for studieregistrering
Først indsendt
13. april 2022
Først indsendt, der opfyldte QC-kriterier
19. maj 2022
Først opslået (Faktiske)
20. maj 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- B2020-063(2)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .