Hypothalamic Obesity due to Childhood Cancer with Cranial Insults MedDRA version: 8.1 Level: LLT Classification code 10021111
Conditions
Interventions
Trade Name: Somatuline Autogel 60mg
Product Name: Somatuline Autogel
Pharmaceutical Form: Solution for injection
INN or Proposed INN: lanreotide
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Royal Marsden Foundation Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients can be male or female and must be between 8 and 18 years of age inclusive. •Patients must have a diagnosis of HO induced by brain tumour or cranial irradiation for acute lymphoblastic leukaemia (ALL) or other childhood cancers. •The patient must have at least one other hypothalamic–pituitary dysfunction. •The patient must have a body mass index (BMI) = International Obesity Task Force line applicable to children, which is the equivalent to WHO adult definition of obesity at 18 years (BMI 30 kg/m2 = obesity. •The patient must have been unable to maintain a stable BMI over the previous 6 months. •The patient and the patient’s family must be able and willing to comply with the requirements of the protocol. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: It has been < 1 year since the patient completed their oncological treatment. •It has been < 1 year since the patient completed their oncological treatment. Any evidence of tumour progression/relapse. Diabetes mellitus. Any medication for weight loss within the 3 months prior to screening. Supraphysiological doses of hydrocortisone replacement within the year prior to screening. Cyclosporin therapy within 3 months prior to screening or is anticipated to require treatment with cyclosporine during the study period. History of clinically significant hepatic/gallbladder disease. The patient and/or their parent or guardian are unable to speak / read sufficient English to participate fully in the group therapy sessions. Prior treatment with a somatostatin analogue within the year prior to screening. A known allergy or hypersensitivity to any of the test compounds or materials. Pregnancy or lactation. Female patients of child-bearing potential must have a negative urine pregnancy test at the baseline. Female at risk of pregnancy during the study, not taking adequate precautions against pregnancy. The patient has significant learning difficulties that in the judgment of the Investigator would affect the patient’s ability to understand or comply with any aspect of the protocol. Any investigational drug therapy within 30 days prior to the study, or is scheduled to receive such a drug during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of 24 weeks intervention with low glycaemic index lifestyle (LGIL) plus a Somatuline Autogel Placebo (Placebo and LGIL) or a combination of LGIL plus Somatuline Autogel (SSTa and LGIL) on body weight at Week 24 in comparison to Baseline, at Week 48 and pre-study values.;Primary end point(s): The proportion of children able to maintain a stable weight (defined as no more than one kilogram gain) over a 6 month period.;Secondary Objective: •To assess the effect of the interventions on all anthropometric parameters •To assess the effect of the interventions on fasting insulin, glucose and lipid profile •To assess the effect of the interventions on quality of life (using PedsQL instrument) and self esteem (using The Piers Harris Self Concept Scale) •To assess the effect of the interventions on physical activity (using a walking exercise test and a pedometer). •To assess the effect of the interventions on family eating pattern/eating behavior (using the DEBQ) and family functioning (using FRI) •To assess the acceptability of the interventions to children and families (using an acceptability questionnaire) •To assess the safety and tolerability of the interventions in terms of adverse events, changes in concomitant medications, physical examination findings, changes in vital signs, laboratory assessment findings, ultrasound findings and injection tolerability. | — |
Countries
United Kingdom
Outcome results
None listed