Metabolic DiseasesNCT02629926
Transitional Growth Hormone (GH) Use in Growth Hormone Deficient (GHD) Cancer Survivors
An observational study of Metabolic Diseases and Cancer, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 22 years
- Conditions the study is for
- Metabolic Diseases, Cancer
- What is being tested?
- GH Replacement (NutropinAq®) and No additional treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2010to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients will be identified in the late effects endocrine clinic aged between 16-22 years, which are severely growth hormone deficient.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
The Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
R&I Administrator, 0113 392 0152, leedsth-tr.lthtresearch@nhs.net
About this study
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.
- Conditions
- Metabolic Diseases, Cancer
- Being tested
- GH Replacement (NutropinAq®), No additional treatment
- Medical subject headings
- Metabolic Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GH Replacement (NutropinAq®)Other
GH Replacement continued.
No additional treatmentOther
GH Replacement not continued.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: No additional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
three generic selfrating questionnaires
Measured: 12 monthly intervals until the age of 25yrs
Psychological General WellBeing Schedule (PGWBS)
Questionnaire completed at 12 months
Measured: 12 monthly intervals until the age of 25yrs
Shortform 36 (SF36) questionnaire
Questionnaire completed at 12 months
Measured: 12 monthly intervals until the age of 25yrs
EuroQoL 5D (EQ5D) questionnaire
AGHDA SF36 PGWBS EQ5D
Measured: 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.
Weight Height Waist \& hip circumference Skin thickness Bioimpedance Total body DXA scan
Measured: 12 monthly intervals until the age of 25yrs
compare the change in cardiovascular risk factors between the two treatment groups at each assessment every 12 months versus Baseline.
Measured: 12 monthly intervals until the age of 25yrs
compare the change in bone mineral content between the two treatment groups at each assessment every 12 months versus Baseline.
Measured: 12 monthly intervals until the age of 25yrs
compare the change in bone turnover between the two treatment groups at each assessment timepoint versus Baseline.
Measurements of:
DXA Scan
- Total bone mineral content
- Bone mineral density at hips and lumbar spine Serum Osteocalcin 24-hour urinary excretion of deoxypyridinoline cross-links
Measured: 12 monthly intervals until the age of 25yrs
To assess the safety of GH treatment (IGF-I, Blood glucose, HbA1C, Blood pressure, Side effect questionnaire, Adverse events, Scheduled or unscheduled laboratory findings, Changes in concomitant medication)
IGF-I Blood glucose HbA1C Blood pressure Side effect questionnaire Adverse events Scheduled or unscheduled laboratory findings Changes in concomitant medication
Measured: 12 monthly intervals until the age of 25yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study startOct 2010
- Primary completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629926
- Sponsor's protocol ID
- ED07/8440
- Status last verified
- Dec 2015
- First submitted
- 9 Feb 2015
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02629926
- Acronym / sponsor ID
- ED07/8440
- Conditions
- Metabolic Diseases, Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2015 (actual)
- First posted
- 15 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients to receive GH replacement | – | Other: GH Replacement (NutropinAq®)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 |
| Patients who will not receive GH replacement | – | Other: No additional treatmentAn additional 30 patients who elect not to receive growth hormone replacement will provide a parallel control data. |
Who may qualify
- Ages
- 16 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients will be identified in the late effects endocrine clinic aged between 16-22 years, which are severely growth hormone deficient.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GH Replacement (NutropinAq®)GH Replacement continued. | Other | Patients to receive GH replacement |
| No additional treatmentGH Replacement not continued. | Other | Patients who will not receive GH replacement |
Primary outcome
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
Time frame: 12 monthly intervals until the age of 25yrs
9 secondary outcomes
compare the change in QoL at each assessment timepoint versus to Baseline for the two treatment groups
Time frame: 12 monthly intervals until the age of 25yrs
Psychological General WellBeing Schedule (PGWBS)
Time frame: 12 monthly intervals until the age of 25yrs
Shortform 36 (SF36) questionnaire
Time frame: 12 monthly intervals until the age of 25yrs
EuroQoL 5D (EQ5D) questionnaire
Time frame: 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.
Time frame: 12 monthly intervals until the age of 25yrs
compare the change in cardiovascular risk factors between the two treatment groups at each assessment every 12 months versus Baseline.
Time frame: 12 monthly intervals until the age of 25yrs
compare the change in bone mineral content between the two treatment groups at each assessment every 12 months versus Baseline.
Time frame: 12 monthly intervals until the age of 25yrs
compare the change in bone turnover between the two treatment groups at each assessment timepoint versus Baseline.
Time frame: 12 monthly intervals until the age of 25yrs
To assess the safety of GH treatment (IGF-I, Blood glucose, HbA1C, Blood pressure, Side effect questionnaire, Adverse events, Scheduled or unscheduled laboratory findings, Changes in concomitant medication)
Time frame: 12 monthly intervals until the age of 25yrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Diseases and Cancer, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 12 monthly intervals until the age of 25yrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2015.