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

NCT07835165 | Not Yet Recruiting

• 2 other identifiers: RCAPHM23_0030ID RCB: 2024-A00186-41
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Craniopharyngioma

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Secondary Outcomes (26)

• Relative weight change 15 days after surgery

  15 days

• Relative weight change 3 months after surgery

  3 months

• Relative weight change 1 year after surgery

  1 year

• Absolute weight change 15 days after surgery

  15 days

• Absolute weight change at 3 months post-surgery

  3 months

Study Arms (2)

Retrospective group

NO INTERVENTION

Prospective group

EXPERIMENTAL

Other: Intensive dietary care

Interventions

Intensive dietary care OTHER

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

Prospective group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

MeSH Terms

Conditions

Craniopharyngioma

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 22, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: September 22, 2026

Record last verified: 2026-09