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Advanced CancerPhase 1/2NCT00933361

Individual Dose-escalated Bi-daily Subcutaneously (sc) Ghrelin in Cancer Cachexia: a Phase I/II Study

A Phase 1/2 study testing ghrelin in people with Advanced Cancer and Cachexia, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Cachexia, a condition of severe malnutrition, negative nitrogen balance, muscle wasting, weight loss, and anorexia, is a frequent affecting more than 80% of patients in advanced cancer disease causing a high burden on patients and their families. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Cancer, Cachexia
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
21 participants
Where
1 siteSwitzerland
Study dates
Jun 2009to Dec 2011
Phase
Phase 1/2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: Patients must be older than 18 years of age
  • Tumour situation: Patients with any type of advanced (defined as locally recurrent or metastatic), incurable solid tumour.
  • Cachexia: defined as involuntary loss of weight of ≥2% in 2 months or ≥5% in 6 months, and ongoing in the last 4 weeks
  • No simple starvation: Patients must be able to eat, defined as no severe structural barriers in the upper gastrointestinal tract and no bowel obstruction.
  • No late cachexia: Patient must have an expected life expectancy > 3 months
  • No anti-cachexia or appetite-stimulating medications: Patients are not allowed to have corticosteroids unless for maximum 2 days for chemotherapy, no progestin therapy within the last 2 weeks, no anabolic drugs within the last month. Prokinetic medication, NSAR (paracetamol and novamin sulphate are allowed, if given in a fixed dose for two weeks before visit 1, and expected to be given during the whole trial period.
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  • Laboratory test results within these ranges: Absolute neutrophil count ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L, serum creatinine ≤ 2.0 mg/dL (177 μmol/L), creatinine clearance ClCr ≥ 50ml/min, total bilirubin ≤1.5 mg/dL (25μmol/L), and AST (SGOT)/ ALT (SGPT) ≤2 x ULN or if hepatic metastases are present ≤ 5 x ULN.
  • No other trial: Patient is not or was not participating in any other clinical trial within 28 before visit 2.
  • Women of childbearing potential: A negative pregnancy test \& effective contraception are mandatory in child-bearing age.
  • Men agree not to father a child (i.e. use adequate birth control if sexually active) during participation in the trial.
  • Cognition: Presence of a normal level of consciousness (mandatory is a normal abbreviated screening mini-mental test or a common mini-mental ≥ 27/30; in elderly patients age ≥ 65 years or patients with low education a mini mental status of ≥25/30 points will be considered adequate).
  • Consent: The patient has voluntarily signed and dated an independent Ethics Committee (IEC) approved consent prior to any study-specific procedures.
  • Gastrectomy: Patients with history of gastrectomy are eligible.

Who cannot join

  • Questionnaires: Any psychiatric disorder, alcohol and illicit drug abuser language problem that would prevent the patient from filling in the questionnaires adequately.
  • Patient with a history of psychiatric diagnosis of depression or clinical diagnosis of depression as determined by the treating physician or Hospital Anxiety Depression Scale total score of 13 or greater.
  • History of alcohol abuse as determined by the CAGE questionnaire (≥2/4) or history of illicit drug abuse within last 12 months.
  • Parenteral nutrition
  • Diabetes mellitus with secondary organ dysfunction: coronary heart disease, previous stroke, renal insufficiency
  • Patients with cerebral metastases or prophylactic whole brain irradiation for possible cerebral metastases.
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  • Known hypersensitivity to ghrelin.
  • Known infection with HIV or a viral hepatitis
  • Patients with known myeloid malignancy or tumours having bone marrow involvement
  • Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Cantonal Hospital St. Gallen KSSG

    Sankt Gallen, 9000

Other trials in Switzerland

About this study

Official title: Individual Dose-escalated Bi-daily sc Ghrelin in Cancer Cachexia: a Phase I/II Study

Cachexia, a condition of severe malnutrition, negative nitrogen balance, muscle wasting, weight loss, and anorexia, is a frequent affecting more than 80% of patients in advanced cancer disease causing a high burden on patients and their families. Nutritional, pharmacological, and behavioural interventions for cancer-related ACS and associated symptoms have, despite the importance for cancer care, limited effect on only a minority of patients. New strategies are required.

Ghrelin, a 28 amino acid peptide discovered in 1999, is predominantly secreted by gastric endocrine cells and is an endogenous ligand for the growth hormone secretagogue (GHS) receptor. When administered peripherally it stimulates growth hormone secretion, food intake, triggers a positive energy balance, produces weight gain through a central mechanism involving hypothalamic neuropeptides and has anti-inflammatory effects. A recently completed trial on intravenous ghrelin in advanced cancer patients with ACS reports good tolerability and safety of single intravenous application of 2 and 8μg/kg Ghrelin.

Given the facts that ACS is a major burden in patients suffering advanced cancer disease and ghrelin is a major signal for stimulating food intake, promoting positive energy balance and weight gain and may have anti-inflammatory effect it remains to be determined whether the administration of ghrelin will have a positive clinical effect on cancer anorexia/ cachexia syndrome ACS. The next logical clinical development step is a proper dose-finding study of twice daily subcutaneous administration and proof-of-concept of main outcomes.

Being tested
ghrelin
Keywords
Adult
Medical subject headings
Cachexia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ghrelinDrug

    As starting dose the investigators choose a dose level which was shown in our last study to be safe in human beings, i.e. 8μg/kg intravenously. With an assumed bioavailability of 25% of subcutaneously administered ghrelin the corresponding dose for dose level 1 is therefore 32 μg/kg. In the first 4 dose levels for each subsequent dose level the dose is increased by 50% compared to the previous one, from the 5th dose level onwards the increase is 25%: Dose level 1 = 32 μg/kg Dose level 2 = 48 μg/kg Dose level 3 = 72 μg/kg Dose level 4 = 108 μg/kg Dose level 5 = 135 μg/kg Dose level 6 = 169 μg/kg Dose level 7 = 211 μg/kg The investigators define the maximum tolerable dose as 20mg ghrelin (equivalent to 5ml) for reasons of the high drug volume to be administered subcutaneously.

Study groups in NCT00933361
Study groupRoleWhat they receive
ghrelinExperimentalGhrelin, a 28 amino acid peptide discovered in 1999, is predominantly secreted by gastric endocrine cells and is an endogenous ligand for the growth hormone secretagogue (GHS) receptor. When administered peripherally it stimulates growth hormone secretion, food intake, triggers a positive energy balance, produces weight gain through a central mechanism involving hypothalamic neuropeptides and has anti-inflammatory effects
Receives: Drug: ghrelin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess the dose of ghrelin in tumour patients with ACS causing optimal stimulation of nutritional intake - minimal dose for maximal nutritional intake (MD-MANI) - or the maximally tolerable dose (MTD), which one occurs first

    Measured: bi-weekly

  2. To assess the effect of ghrelin on muscle strength.

    Measured: weekly

Secondary outcomes (2)

  1. To assess the toxicity and tolerability, pharmacokinetics and symptoms of eating of ghrelin.

    Measured: bi-weekly

  2. To assess the effect of ghrelin on muscle mass, physical function, safety, toxicity and tolerability, pharmacokinetics, symptoms of eating, gastrointestinal motility, inflammation

    Measured: weekly

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionDec 2011
  4. Study completionDec 2011

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00933361
Sponsor's protocol ID
SG 294/08
Status last verified
Jul 2017
First submitted
6 Jul 2009
Last updated
1 Aug 2017
Results posted
No
Data monitoring committee
No

Publications

  • Strasser F, Lutz TA, Maeder MT, Thuerlimann B, Bueche D, Tschop M, Kaufmann K, Holst B, Brandle M, von Moos R, Demmer R, Cerny T. Safety, tolerability and pharmacokinetics of intravenous ghrelin for cancer-related anorexia/cachexia: a randomised, placebo-controlled, double-blind, double-crossover study. Br J Cancer. 2008 Jan 29;98(2):300-8. doi: 10.1038/sj.bjc.6604148. Epub 2008 Jan 8.

    PubMed 18182992

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ghrelin in people with Advanced Cancer and Cachexia, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.

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 13 inclusion and 11 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 1 Aug 2017. 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 Switzerland. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

To assess the dose of ghrelin in tumour patients with ACS causing optimal stimulation of nutritional intake - minimal dose for maximal nutritional intake (MD-MANI) - or the maximally tolerable dose (MTD), which one occurs first (time frame: bi-weekly). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00933361, which also lists 1 linked publication.

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 1 Aug 2017.

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