Cancer Clinical Trial
Official title:
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
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.
n/a
Observational Model: Case-Only, Time Perspective: Prospective
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