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

NCT00300664 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2006-10-13

No results posted yet for this 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.

Conditions

Interventions

DRUG

Human Growth hormone

Sponsors & Collaborators

  • Royal Marsden NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Ray Powles, FRCP, FRCPath · Royal Marsden NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-07-31
Completion
2005-04-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00300664 on ClinicalTrials.gov