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

NCT02629926 | Unknown

• 1 other identifier: ED07/8440
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Compare the change in quality of life (QoL) at twelve months with that at baseline for the two treatment groups. For the primary endpoint this will be determined using the GH -specific instrument, the Adult Growth

  12 monthly intervals until the age of 25yrs

Secondary Outcomes (9)

• compare the change in QoL at each assessment timepoint versus to Baseline for the two treatment groups

  12 monthly intervals until the age of 25yrs

• Psychological General WellBeing Schedule (PGWBS)

  12 monthly intervals until the age of 25yrs

• Shortform 36 (SF36) questionnaire

  12 monthly intervals until the age of 25yrs

• EuroQoL 5D (EQ5D) questionnaire

  12 monthly intervals until the age of 25yrs

• compare the change in body composition between the two treatment groups at each assessment timepoint versus Baseline.

  12 monthly intervals until the age of 25yrs

Study Arms (2)

Patients to receive GH replacement

30 patients will be recruited to the study who wishes to continue receiving growth hormone replacement, all of whom will receive NutorpinAq Recombinant growth hormone

Other: GH Replacement (NutropinAq®)

Patients who will not receive GH replacement

An additional 30 patients who elect not to receive growth hormone replacement will provide a parallel control data.

Other: No additional treatment

Interventions

GH Replacement (NutropinAq®) OTHER

GH Replacement continued.

Patients to receive GH replacement

No additional treatment OTHER

GH Replacement not continued.

Patients who will not receive GH replacement

Eligibility Criteria

• Age: 16 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients will be identified in the late effects endocrine clinic aged between 16-22 years, which are severely growth hormone deficient.

You may qualify if:

• Aged 16--22 years inclusive.
• Both genders.
• Able to provide informed consent.
• Severe GH deficiency (peak GH\<5mcg/l on stimulation).
• No GH replacement therapy during the three months preceding the baseline visit.
• Stable anterior pituitary hormone (i.e. sex steroids, hydrocortisone, thyroxine) therapy over the previous six months.
• Life expectancy \>24 months.

You may not qualify if:

• Acute critical illness (Patients suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure, or similar conditions).
• Active malignant disease (i.e. undergoing active treatment or palliation).
• Patients treated for an intracranial malignancy should have completed therapy two years prior to entering the study.
• Active Cushing's disese or acromegaly
• Pregnancy or desire to conceive within the following year. Patients at risk of pregnancy will be screened by urine pregnancy (HCG) test at the baseline evaluation \& treatment initiation visit.
• Breast feeding.
• Proliferative diabetic retinopathy.
• Sensitivity to GH or its preservative

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust: lead

Study Sites (1)

The Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Metabolic Diseases; Neoplasms

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2015
• First Posted: December 15, 2015
• Study Start: October 1, 2010
• Primary Completion: October 1, 2015
• Last Updated: December 15, 2015

Record last verified: 2015-12

Locations

GB (1)