CraniopharyngiomaCRANIODIETNCT07835165
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
A study testing Intensive dietary care in people with Craniopharyngioma, run by Assistance Publique Hopitaux De Marseille.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Craniopharyngioma
- What is being tested?
- Intensive dietary care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 Jul 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- - 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:
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- 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.
About this study
Official title: 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.).
Read more
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.
- Conditions
- Craniopharyngioma
- Being tested
- Intensive dietary care
- Medical subject headings
- Craniopharyngioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive dietary careOther
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
| Study group | Role | What they receive |
|---|---|---|
| Retrospective group | No intervention | Not described |
| Prospective group | Experimental | Not described Receives: Other: Intensive dietary care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative weight change at 1 year post-surgery of a craniopharyngioma
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
Measured: 1 year
Secondary outcomes (26)
Relative weight change 15 days after surgery
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
Measured: 15 days
Relative weight change 3 months after surgery
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
Measured: 3 months
Relative weight change 1 year after surgery
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
Measured: 1 year
Absolute weight change 15 days after surgery
Difference between the weight recorded during the dietary consultation 15 days after surgery and that recorded during the preoperative consultation
Measured: 15 days
Absolute weight change at 3 months post-surgery
the difference between the weight recorded during the dietary consultation 3 months post-surgery and that recorded during the preoperative consultation
Measured: 3 months
Absolute weight change at 1 year post-surgery
the difference between the weight recorded during the dietary consultation 1 year post-surgery and that recorded during the preoperative consultation
Measured: 1 year
Weight before surgery and then 15 days, 3 months, and 1 year after surgery
Wheigh collecting on a weighing machine
Measured: 15 days, 3 months and 1 year
Absolute change in BMI 15 days after surgery
difference between the BMI recorded during the dietary consultation 15 days after surgery and that recorded during the preoperative consultation
Measured: 15 days
Absolute change in BMI 3 months after surgery
difference between the BMI recorded during the dietary consultation 3 months after surgery and that recorded during the preoperative consultation
Measured: 3 months
Absolute change in BMI at 1 year after surgery
difference between the BMI recorded during the dietary consultation 1 year after surgery and that recorded during the preoperative consultation
Measured: 1 year
Relative change in BMI 15 days after surgery
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
Measured: 15 days
Relative change in BMI at 3 months post-surgery
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
Measured: 3 months
Relative change in BMI at 1 year after surgery
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
Measured: 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
Number of patients in each BMI category (Calculation of BMI according to Quetelet's formula) 15 days, 3 months and 1 year after surgery
Measured: 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
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
Measured: 15 days, 3 months and 1 year
Percentage of intermediate weight gain at each consultation
Result of the calculation of divided the weight at today's consultation by the weight at the last consultation
Measured: 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
Number of patients presenting one or more biological abnormalities related to overweight or obesity (fasting blood glucose, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides)
Measured: 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
Number of patients with abnormal fasting blood glucose levels
Measured: 15 days, 3 months, and 1 year
Percentage of patients with abnormal total cholesterol levels 15 days, 3 months, and 1 year after surgery
Number of patients with abnormal total cholesterol levels
Measured: 15 days, 3 months, and 1 year
Percentage of patients with abnormal HDL cholesterol levels 15 days, 3 months, and 1 year after surgery
Number of patients with abnormal HDL cholesterol levels
Measured: 15 days, 3 months, and 1 year
Percentage of patients with abnormal LDL cholesterol levels 15 days, 3 months, and 1 year after surgery
Number of patients with abnormal LDL cholesterol levels
Measured: 15 days, 3 months, and 1 year
Percentage of patients with abnormal triglyceride levels at 15 days, 3 months, and 1 year after surgery
Number of patients with abnormal triglyceride levels
Measured: 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
Analysis of quality of life questionnaires (WHOQOL-BREF)
Measured: 15 days, 3 months and 1 year
Total energy intake
Assessment of total energy intake calculated from dietary intake, including proteins, lipids and carbohydrates.Unit of Measure: kcal
Measured: 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
Analysis of the Dietary Behaviour and Eating Feelings Questionnaire (DEBQ)
Measured: 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
Impedance measurement
Measured: 15 days, 3 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Apr 2030 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CraniopharyngiomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835165
- Sponsor's protocol ID
- RCAPHM23_0030
- Other IDs
- ID RCB: 2024-A00186-41
- Acronym
- CRANIODIET
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No