Status:
COMPLETED
A Randomized Trial of Human Growth Hormone (hGH) vs Placebo in Intensively Treated Haemato-Oncology Patients.
Lead Sponsor:
Royal Marsden NHS Foundation Trust
Conditions:
Multiple Myeloma
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
About 90% of patients with haemato-oncologic malignancy lose their body muscle mass and also lose weight either due to chemotherapy induced nausea/vomiting or the high catabolic state due to fever, se...
Eligibility Criteria
Inclusion
- \- Age \>= 18 years 2. Patients with haematological malignancies receiving neutropenia (\< 0.5 x 109/L) inducing chemotherapy (+/- TBI) requiring hospitalisation.
- 3\. Negative pregnancy test if the patient is of childbearing potential 4. Informed consent
Exclusion
- . Previous treatment with growth hormone 2.Unstable psychiatric conditions 3. Uncontrolled endocrine disorders 4.Chronic severe liver disease: AST or ALT\>3x upper limit of normal range 5. Chronic severe renal disease: creatinine\>150 µM or repeated positive test for haematuria or proteinuria 6. Severe congestive heart failure 7. Aortic stenosis associated with clinical symptoms eg syncope of angina pectoris 8. Hypertrophic cardiomyopathy 9. Uncontrolled hypertension (diastolic blood-pressure \> 105 mm Hg) 10. Diabetes mellitus that is not well controlled with insulin/antidiabetic drugs 11. Severe respiratory disease 12. Known or suspected allergy to growth hormone or any of its constituents 13. History of drug or alcohol abuse within two years prior to study enrolment 14. Exposure to another investigational medication or device currently or within three months prior to enrolment.
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
End Date :
April 1 2005
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00300664
Start Date
July 1 2002
End Date
April 1 2005
Last Update
October 13 2006
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