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A Comparative Study Evaluating the Impact of Intensive Dietary Care on Weight Change and Biological Parameters in Patients Who Underwent Surgery for Craniopharyngioma During the First Postoperative Year (CRANIODIET)

18. september 2026 opdateret af: Assistance Publique Hopitaux De Marseille

A Comparative Historical-prospective "Before/After" Study Evaluating the Impact of Intensive Dietary Care on Weight Change and Biological Parameters in Patients Who Underwent Surgery for Craniopharyngioma During the First Postoperative Year

Craniopharyngiomas are rare benign tumors that develop in the hypothalamic-pituitary region. Their prevalence is estimated at approximately 1 in 50,000 people in France.

The main symptoms associated with this condition are headaches and visual, neurological, and hormonal disorders. These symptoms appear when the tumors are large enough to compress adjacent structures (optic chiasm, pituitary gland, etc.).

The current standard treatment is surgical removal via endonasal approach or craniotomy, most often combined with adjuvant radiotherapy. One of the common postoperative complications is significant and rapid weight gain leading to obesity, which occurs in 26 to 61% of cases depending on the type of surgery.

These disorders can cause impulsive eating, hyperphagia, and persistent hunger, leading to deleterious metabolic consequences with an increase in comorbidities (diabetes, cardiovascular disease, joint problems, abnormal blood tests, asthma, etc.). They can also have psychosocial consequences, with a significant risk of professional and personal activity cessation during the first year after surgery due to asthenia and other possible postoperative complications (dizziness, discomfort, etc.).

In addition, this surgery alters the functioning of the pituitary gland, requiring lifelong hormone supplementation, particularly with hydrocortisone, a hormone that is essential for stress management and energy release. The optimal doses for these replacement therapies are difficult to determine. They are most often found at the end of the first year after surgery, which can then allow for a gradual resumption of normal social and professional activities and better control of health and dietary advice. This first year after surgery is therefore a pivotal year in the possible development of obesity in these patients, which justifies the importance of intensive dietary care offered to these patients as early as possible.

The investigators hypothesise that intensive dietary care could prevent weight gain and an increase in comorbidities in patients who have undergone surgery for craniopharyngioma.

The primary objective of this study is to evaluate the impact of intensive dietary care (intervention group in a prospective phase) versus usual care (control group in a retrospective pre-intervention phase) on the relative weight change in patients one year after the first resection of a craniopharyngioma.

The primary endpoint is the relative change in weight at 1 year post-surgery, i.e. the difference between the weight recorded at the last dietary consultation 1 year post-surgery and that recorded at the preoperative consultation, relative to the weight recorded at the preoperative consultation.

This study is a comparative, quasi-experimental before/after study, with a pre-control phase corresponding to patients who have undergone surgery for their craniopharyngioma and have received standard dietary management versus an interventional 'after' phase, corresponding to patients who will undergo surgery for their craniopharyngioma and who will receive intensive dietary management. The study is single-centre, with 50 patients to be recruited in the control group and 25 in the intervention group.

The expected results are to assess whether intensive dietary care (versus standard care) can limit weight gain in the year following the first removal of a craniopharyngioma, as well as its impact on socio-professional activities and the onset of comorbidities.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Ikke rekrutterer endnu

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
75

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Ikke anvendelig

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

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Retrospective group:

    • Male or female patients aged between 18 and 70 (outside this age range, the BMI criteria are different).
    • Patients with craniopharyngioma who underwent initial craniopharyngioma resection surgery in Prof. Dufour's neurosurgery department at La Timone Hospital (APHM) between 1 January 2017 and 31 December 2021.
    • Weight data available at 15 days, 3 months and 1 year after their initial surgery in the Electronic Patient Record (EPR).
    • Patient informed and not opposed to the reuse of their data.

  • Prospective group:

    • Male or female patients aged between 18 and 70 (outside this age range, the BMI criteria are different).
    • Patients with craniopharyngioma in the immediate preoperative period of a first craniopharyngioma resection scheduled to be performed in Prof. Dufour's neurosurgery department at La Timone Hospital (APHM).
    • Patients affiliated with or covered by a social security scheme.
    • Patients who have signed a free, written and informed consent form.
    • Patients who have scales at home and are able to weigh themselves.

Exclusion Criteria:

  • - Retrospective group:

    • Patients with type 1 diabetes due to possible weight variation linked to a potential imbalance in diabetes.
    • Patients with a history of bariatric surgery, whose weight loss could be skewed by the surgical procedure (low food intake) and by changes in the secretion of the hormones leptin (satiety hormone) and ghrelin (hunger hormone), which are possible confounding factors.
    • Patients with recurrent craniopharyngioma who have a history of craniopharyngioma surgery or radiotherapy treatment for this tumour. These patients may already have hypothalamic disorders, eating disorders or weight gain following the initial removal of the craniopharyngioma.
    • Adult patients under guardianship or curatorship. Pregnant or breastfeeding women.

  • Prospective group:

    • Patients with memory disorders that prevent them from following dietary guidelines.
    • Patients with type 1 diabetes due to possible weight variation linked to a potential imbalance in diabetes.
    • Patients with a history of bariatric surgery, whose weight loss could be skewed by the surgical procedure (low food intake) and by changes in the secretion of the hormones leptin (satiety hormone) and ghrelin (hunger hormone), which are possible confounding factors.
    • Patients with recurrent craniopharyngioma who have a history of craniopharyngioma surgery or radiotherapy treatment for this tumour. These patients may already have hypothalamic disorders, eating disorders or weight gain following the initial removal of the craniopharyngioma.
    • Adult patients under guardianship or curatorship.
    • Pregnant or breastfeeding women.
    • Pregnancy (self-reported) or breastfeeding and all other categories of persons benefiting from special protection under the French Public Health Code (CSP): patients under legal protection, patients hospitalised without consent, patients admitted to social or health facilities for care and not for research, and patients in emergency situations.
    • Patients unable to give informed consent or who refuse to participate in the study.

Patient already participating in an interventional study on craniopharyngioma.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Ingen indgriben: Retrospective group
Eksperimentel: Prospective group
Andet: Intensive dietary care

Intensive dietary care following surgery for a craniopharyngioma with 3 visits 2 weeks prior surgery, and 3 months after surgery associated with a follow up every 2 weeks over a year after surgery

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Relative weight change at 1 year post-surgery of a craniopharyngioma
Tidsramme: 1 year

Difference between the weight recorded at the last dietary consultation 1 year post-surgery and that recorded at the preoperative consultation, relative to the weight recorded at the preoperative consultation
1 year

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Relative weight change 15 days after surgery
Tidsramme: 15 days

Difference between the weight recorded during the dietary consultation 15 days after surgery and that recorded during the preoperative consultation, relative to the weight recorded during the preoperative consultation
15 days
Relative weight change 3 months after surgery
Tidsramme: 3 months

difference between the weight recorded during the dietary consultation 3 months after surgery and that recorded during the preoperative consultation, relative to the weight recorded during the preoperative consultation
3 months
Relative weight change 1 year after surgery
Tidsramme: 1 year

Difference between the weight recorded during the dietary consultation 1 year after surgery and that recorded during the preoperative consultation, relative to the weight recorded during the preoperative consultation
1 year
Absolute weight change 15 days after surgery
Tidsramme: 15 days

Difference between the weight recorded during the dietary consultation 15 days after surgery and that recorded during the preoperative consultation
15 days
Absolute weight change at 3 months post-surgery
Tidsramme: 3 months

the difference between the weight recorded during the dietary consultation 3 months post-surgery and that recorded during the preoperative consultation
3 months
Absolute weight change at 1 year post-surgery
Tidsramme: 1 year

the difference between the weight recorded during the dietary consultation 1 year post-surgery and that recorded during the preoperative consultation
1 year
Weight before surgery and then 15 days, 3 months, and 1 year after surgery
Tidsramme: 15 days, 3 months and 1 year

Wheigh collecting on a weighing machine
15 days, 3 months and 1 year
Absolute change in BMI 15 days after surgery
Tidsramme: 15 days

difference between the BMI recorded during the dietary consultation 15 days after surgery and that recorded during the preoperative consultation
15 days
Absolute change in BMI 3 months after surgery
Tidsramme: 3 months

difference between the BMI recorded during the dietary consultation 3 months after surgery and that recorded during the preoperative consultation
3 months
Absolute change in BMI at 1 year after surgery
Tidsramme: 1 year

difference between the BMI recorded during the dietary consultation 1 year after surgery and that recorded during the preoperative consultation
1 year
Relative change in BMI 15 days after surgery
Tidsramme: 15 days

the difference between the BMI recorded during the dietary consultation 15 days after surgery and that recorded during the preoperative consultation, relative to that recorded during the preoperative consultation
15 days
Relative change in BMI at 3 months post-surgery
Tidsramme: 3 months

difference between the BMI recorded during the dietary consultation 3 months post-surgery and that recorded during the preoperative consultation, relative to that recorded during the preoperative consultation
3 months
Relative change in BMI at 1 year after surgery
Tidsramme: 1 year

the difference between the BMI recorded during the dietary consultation 1 year after surgery and that recorded during the preoperative consultation, relative to that recorded during the preoperative consultation
1 year
Percentage of patients who are overweight (BMI between 25 and 29.9 kg/m²) 15 days, 3 months and 1 year after surgery
Tidsramme: 15 days, 3 months and 1 year

Number of patients in each BMI category (Calculation of BMI according to Quetelet's formula) 15 days, 3 months and 1 year after surgery
15 days, 3 months and 1 year
Percentage of patients in each BMI category according to the World Health Organisation classification at 15 days, 3 months and 1 year after surgery
Tidsramme: 15 days, 3 months and 1 year

Number of patients in each BMI category according to the World Health Organisation classification (Calculation of BMI according to Quetelet's formula) at 15 days, 3 months and 1 year after surgery. Classification is as follow:

  • Normal: 18.5 to 24.9 kg/m²,
  • Overweight: 25 to 29.9 kg/m²,
  • Grade 1 obesity: 30 to 34.9 kg/m²,
  • Grade 2 obesity: 35 to 39.9 kg/m²,
  • Grade 3 obesity: 40 to 49.9 kg/m²,
  • Grade 4 obesity: > 50 kg/m²
15 days, 3 months and 1 year
Percentage of intermediate weight gain at each consultation
Tidsramme: 1 week or 15 days

Result of the calculation of divided the weight at today's consultation by the weight at the last consultation
1 week or 15 days
Percentage of patients presenting one or more biological abnormalities related to overweight or obesity (fasting blood glucose, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides) 15 days, 3 months, and 1 year after surgery
Tidsramme: 15 days, 3 months, and 1 year

Number of patients presenting one or more biological abnormalities related to overweight or obesity (fasting blood glucose, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides)
15 days, 3 months, and 1 year
Percentage of patients with abnormal fasting blood glucose levels 15 days, 3 months, and 1 year after surgery
Tidsramme: 15 days, 3 months, and 1 year

Number of patients with abnormal fasting blood glucose levels
15 days, 3 months, and 1 year
Percentage of patients with abnormal total cholesterol levels 15 days, 3 months, and 1 year after surgery
Tidsramme: 15 days, 3 months, and 1 year

Number of patients with abnormal total cholesterol levels
15 days, 3 months, and 1 year
Percentage of patients with abnormal HDL cholesterol levels 15 days, 3 months, and 1 year after surgery
Tidsramme: 15 days, 3 months, and 1 year

Number of patients with abnormal HDL cholesterol levels
15 days, 3 months, and 1 year
Percentage of patients with abnormal LDL cholesterol levels 15 days, 3 months, and 1 year after surgery
Tidsramme: 15 days, 3 months, and 1 year

Number of patients with abnormal LDL cholesterol levels
15 days, 3 months, and 1 year
Percentage of patients with abnormal triglyceride levels at 15 days, 3 months, and 1 year after surgery
Tidsramme: 15 days, 3 months, and 1 year

Number of patients with abnormal triglyceride levels
15 days, 3 months, and 1 year
Change in quality of life compared to the preoperative dietary consultation, 15 days, 3 months and 1 year after surgery
Tidsramme: 15 days, 3 months and 1 year

Analysis of quality of life questionnaires (WHOQOL-BREF)
15 days, 3 months and 1 year
Total energy intake
Tidsramme: 15 days, 3 months and 1 year

Assessment of total energy intake calculated from dietary intake, including proteins, lipids and carbohydrates.Unit of Measure: kcal
15 days, 3 months and 1 year
Questionnaire on eating behaviour and feelings about food (DEBQ), pre-operatively, then 15 days, 3 months and 1 year after surgery
Tidsramme: 15 days, 3 months and 1 year

Analysis of the Dietary Behaviour and Eating Feelings Questionnaire (DEBQ)
15 days, 3 months and 1 year
Analysis of body composition (fat mass, lean mass) using an impedance meter (In Body device) 15 days, 3 months and 1 year after surgery
Tidsramme: 15 days, 3 months and 1 year

Impedance measurement
15 days, 3 months and 1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
Assistance Publique Hopitaux De Marseille

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 (Anslået)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
1. januar 2027

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
1. april 2030

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
1. juli 2030

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
10. september 2026

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
18. september 2026

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
22. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
22. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
18. september 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • RCAPHM23_0030
  • ID RCB: 2024-A00186-41 (Anden identifikator: ANSM)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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