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

This study has been completed.
Sponsor:
Information provided by:
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00300664
First received: March 8, 2006
Last updated: October 12, 2006
Last verified: March 2006
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Drug: Human Growth hormone
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind

Resource links provided by NLM:


Further study details as provided by Royal Marsden NHS Foundation Trust:

Estimated Enrollment: 150
Study Start Date: July 2002
Estimated Study Completion Date: April 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

- 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 Criteria:

  • . 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00300664

Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
Principal Investigator: Ray Powles, FRCP, FRCPath Royal Marsden NHS Foundation Trust
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00300664     History of Changes
Other Study ID Numbers: 2128
Study First Received: March 8, 2006
Last Updated: October 12, 2006
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014