Extra diet help after craniopharyngioma surgery
Official title: 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
Status: Not yet recruiting. It has not opened yet. Ask your care team to watch for it if it looks like a fit.
The trial team last updated this record on .
The short version
This study tests close diet support to help limit weight gain after brain tumor surgery.
Read our full plain-language summary
What the trial team says
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.
Key facts
- Registry number
- NCT07835165
- Stage of testing
- Not applicable
- Conditions studied
- Craniopharyngioma
Where it is running
No locations are listed for this trial. The trial's own page may have more.
How to use this
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This page is built from the trial's listing on ClinicalTrials.gov, a service of the U.S. National Library of Medicine. That listing is the authority, and it may have changed since we last read it. We do not run this trial and we cannot enroll you in it.