An interventional study of Intensive dietary care in Craniopharyngioma, sponsored by Assistance Publique Hopitaux De Marseille. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Supportive care
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.
76 studies on the registry are indexed under Craniopharyngioma; 19 are open to participants now.
This study's planned enrollment of 75 is above the median of 40 across 49 interventional studies indexed under Craniopharyngioma.
Browse Craniopharyngioma studies →Assistance Publique Hopitaux De Marseille is the lead sponsor of 702 studies on the registry; 139 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Retrospective group:
Prospective group:
Exclusion Criteria:
- Retrospective group:
Prospective group:
Patient already participating in an interventional study on craniopharyngioma.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: 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
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
Time frame: 1 year
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 year
Weight before surgery and then 15 days, 3 months, and 1 year after surgery
Wheigh collecting on a weighing machine
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 15 days, 3 months and 1 year
No study locations are listed for this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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