A Randomized Trial of Human Growth Hormone (hGH) vs Placebo in Intensively Treated Haemato-Oncology Patients.
1 other identifier
interventional
150
0 countries
N/A
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, sepsis or chemotherapy. This impacts tremendously on the days in hospital and also on the treatment-related complications. Studies with Human Growth hormone (hGH) have shown that it increases lean body mass in adult patients with AIDS and animal models of cancer. At the same time, in vitro studies have shown that hGH has no effect on tumor cell growth. This study is designed to see if the use of hGH in immunocompromised patients with haematological malignancies prevents the loss of muscle mass and weight loss to some extent. This will be a blinded 1:1, randomised study including 150 patients whereby the patients will either receive hGH or a placebo. The doctors and the nurses will not know what drug the patient is receiving. Both hGH and the placebo will be given intravenously (if patients are receiving other intravenous antibiotics or haemopoietic support ) or subcutaneously (if platelets are above 20 x 109/L) The treatment will start on the first day of treatment and continue for 6 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 multiple-myeloma
Started Jul 2002
Shorter than P25 for phase_2 multiple-myeloma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 8, 2006
CompletedFirst Posted
Study publicly available on registry
March 9, 2006
CompletedOctober 13, 2006
March 1, 2006
March 8, 2006
October 12, 2006
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- \- Age \>= 18 years 2. Patients with haematological malignancies receiving neutropenia (\< 0.5 x 109/L) inducing chemotherapy (+/- TBI) requiring hospitalisation.
- \. Negative pregnancy test if the patient is of childbearing potential 4. Informed consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ray Powles, FRCP, FRCPath
Royal Marsden NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 8, 2006
First Posted
March 9, 2006
Study Start
July 1, 2002
Study Completion
April 1, 2005
Last Updated
October 13, 2006
Record last verified: 2006-03