A Phase II, Single-Centre, Randomised, Controlled, Open-Label Clinical Trial to Compare the Efficacy and Safety of Three Therapeutic Interventions on the Treatment of Hypothalamic Obesity due to Childhood Cancer with Cranial Insults - Treatment of hypothalamic obesity due to childhood cancer

Conditions: Hypothalamic Obesity due to Childhood Cancer with Cranial Insults
MedDRA version: 8.1Level: LLTClassification code 10021111

Registration Number: EUCTR2006-000492-16-GB

Lead Sponsor: Royal Marsden Foundation Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

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

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.