NCT02629926

Transitional Growth Hormone (GH) Use in Growth Hormone Deficient (GHD) Cancer Survivors

A Phase IV, Single-Centre, Non-Randomised, Controlled, Open-Label Study to Assess the Use of Growth Hormone (GH) Replacement Therapy (NutropinAq®) During Transition in GH Deficient Survivors of Childhood Cancer to Optimise Somatic Growth & Well-Being

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: The Leeds Teaching Hospitals NHS Trust · Academic / Other
• Sex: All
• Age: 16 Years – 22 Years
• Healthy volunteers: Not accepted

Summary

Cure rates for childhood malignancies have improved at a remarkable pace.With the increasing cure rate came recognition of the long-term detrimental effects of radiotherapy and chemotherapy, known as "late-effects". Endocrine late-effects are particularly prevalent in childhood cancer survivors. Growth Hormone (GH) deficiency is common following radiation to the head and leads to impaired growth, hence GH replacement is given to achieve optimise final height in childhood. In the adult GH is important to maintenance of bone, muscle \& fat mass; vascular risk factors; and quality of life. This observational study aims to determine the long-term effect of low dose GH replacement on development of bone, muscle and fat mass; vascular risk; and quality of life in the early years after achievement of final height, a time known as "transition". GH is thought to be essential to development of bone, muscle, and fat mass during this time period. Patients will be identified in the late -effects endocrine clinic, aged 16-22yrs, who are severely GH deficient. 30 patients will be recruited to the study who wish to continue receiving GH replacement, all of whom will receive recombinant GH. An additional 30 patients who do not wish to receive GH replacement will provide a parallel control data. All patients will undergo baseline assessment including examination; routine blood tests; urine dipstick; measures on height, weight, waist, and 24 hour blood pressure. Measures will be repeated at six months, and then annually until 25 years of age. Bone density will be measured at baseline, after two years and at age 25yrs. Patients requesting GH replacement will require initial additional visits to teach self injection, then 2-4wkly to assess when correct dose of GH is achieved. The study will enable assessment of the beneficial effects of GH replacement during transition in GH deficient survivors of cancer to be realised.

Conditions

• Metabolic Diseases
• Cancer

Interventions

Type	Name	Description
OTHER	GH Replacement (NutropinAq®)	GH Replacement continued.
OTHER	No additional treatment	GH Replacement not continued.

Timeline

• Start date: 2010-10-01
• Primary completion: 2015-10-01
• First posted: 2015-12-15
• Last updated: 2015-12-15

Locations

1 site across 1 country: United Kingdom