A Randomized Trial of Human Growth Hormone (hGH) vs Placebo in Intensively Treated Haemato-Oncology Patients.

Phase

2/3

Condition

Leukemia

Lymphoproliferative Disorders

Anemia

Treatment

N/A

Clinical Study ID

NCT00300664

2128

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age >= 18 years 2. Patients with haematological malignancies receiving neutropenia (< 0.5x 109/L) inducing chemotherapy (+/- TBI) requiring hospitalisation.

Negative pregnancy test if the patient is of childbearing potential 4. Informed consent

Exclusion

Exclusion Criteria:

. Previous treatment with growth hormone 2.Unstable psychiatric conditions 3.Uncontrolled endocrine disorders 4.Chronic severe liver disease: AST or ALT>3x upperlimit of normal range 5. Chronic severe renal disease: creatinine>150 µM or repeatedpositive 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/antidiabeticdrugs 11. Severe respiratory disease 12. Known or suspected allergy to growth hormoneor any of its constituents 13. History of drug or alcohol abuse within two years priorto study enrolment 14. Exposure to another investigational medication or devicecurrently or within three months prior to enrolment.

Study Design

July 01, 2002

April 30, 2005