NCT00681486

Brief Summary

The study is designed to evaluate whether ghrelin treatment can improve appetite in weight losing cancer patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3 cancer

Timeline
Completed

Started Oct 2003

Typical duration for phase_3 cancer

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2003

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2008

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

August 21, 2009

Status Verified

August 1, 2009

Enrollment Period

4.7 years

First QC Date

May 19, 2008

Last Update Submit

August 20, 2009

Conditions

Cancer

Keywords

GhrelinNutritionCancer patientsSurvival

Outcome Measures

Primary Outcomes (1)

  • Food intake

    June 2008

Study Arms (2)

A, 1

ACTIVE COMPARATOR

Ghrelin

Drug: Ghrelin

A, 2

ACTIVE COMPARATOR

Ghrelin.

Drug: Ghrelin

Interventions

GhrelinDRUG

High dose of ghrelin given as subcutaneous injection once a day for the duration of 8 weeks.

A, 1

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Weight loss

You may not qualify if:

  • Diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of surgery, Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

Ghrelin

Intervention Hierarchy (Ancestors)

Peptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Kent Lundholm, MD, prof

    Göteborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 19, 2008

First Posted

May 21, 2008

Study Start

October 1, 2003

Primary Completion

June 1, 2008

Study Completion

July 1, 2008

Last Updated

August 21, 2009

Record last verified: 2009-08

Locations

SE(1)