CancerPhase 3Phase 3NCT00681486
Ghrelin - A Possible Opportunity to Improve Appetite
A Phase 3 study testing Ghrelin in people with Cancer, run by Göteborg University at 1 site in Sweden.
Trial summary
The study is designed to evaluate whether ghrelin treatment can improve appetite in weight losing cancer patients. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cancer
- What is being tested?
- Ghrelin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2003to Jul 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Weight loss
Who cannot join
- Diabetes
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of surgery, Sahlgrenska University Hospital
Gothenburg, 413 45
About this study
Official title: Ghrelin - A Possible Opportunity to Improve Appetite, Nutritional State, Metabolic Integrity and Physical Functioning in Cancer Patients With Progressive Weight Loss
The study is designed to evaluate whether ghrelin treatment can improve appetite in weight losing cancer patients.
Read the detailed description
Randomized study with follow up evaluations each month until preterminal state. Cancer patients will be randomised to either high dose or low dose of active treatment given as daily injection.
- Conditions
- Cancer
- Being tested
- Ghrelin
- Keywords
- Ghrelin, Nutrition, Cancer patients, Survival
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GhrelinDrug
High dose of ghrelin given as subcutaneous injection once a day for the duration of 8 weeks.
GhrelinDrug
Low dose of ghrelin given as subcutaneous injection once a day for the duration of 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| A, 1 | Active comparator | Ghrelin Receives: Drug: Ghrelin |
| A, 2 | Active comparator | Ghrelin. Receives: Drug: Ghrelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food intake
Measured: June 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startOct 2003
- Primary completionJun 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Cancer Foundation, Medical Research Council
- Investigators
- Kent Lundholm, MD, prof, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681486
- Sponsor's protocol ID
- kl4501123
- Acronym
- Phase 3
- Status last verified
- Aug 2009
- First submitted
- 19 May 2008
- Last updated
- 21 Aug 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ghrelin - A Possible Opportunity to Improve Appetite, Nutritional State, Metabolic Integrity and Physical Functioning in Cancer Patients With Progressive Weight Loss
- ClinicalTrials.gov ID
- NCT00681486
- Acronym / sponsor ID
- Phase 3 / kl4501123
- Conditions
- Cancer
- Keywords
- Ghrelin, Nutrition, Cancer patients, Survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Swedish Cancer Foundation, Medical Research Council
- Study start
- Oct 2003
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 21 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to evaluate whether ghrelin treatment can improve appetite in weight losing cancer patients.
Detailed description
Randomized study with follow up evaluations each month until preterminal state. Cancer patients will be randomised to either high dose or low dose of active treatment given as daily injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A, 1 | Active comparator | Drug: GhrelinGhrelin |
| A, 2 | Active comparator | Drug: GhrelinGhrelin. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Weight loss
Key exclusion criteria (1 listed)
- Diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GhrelinHigh dose of ghrelin given as subcutaneous injection once a day for the duration of 8 weeks. | Drug | A, 1 |
| GhrelinLow dose of ghrelin given as subcutaneous injection once a day for the duration of 8 weeks. | Drug | A, 2 |
Primary outcome
Food intake
Time frame: June 2008
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2009.
- Göteborg UniversityLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kent Lundholm, MD, prof principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ghrelin in people with Cancer, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food intake (time frame: June 2008). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2009.