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

Phase 1/Phase 2
18 Years
Open (Enrolling)
Advanced Cancer, Cachexia

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Trial Information

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

Inclusion Criteria


- 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

- 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.


- 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.

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Outcome Time Frame:


Safety Issue:


Principal Investigator

Florian Strasser, PD Dr. MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cantonal Spital St. Gallen


Switzerland: Swissmedic

Study ID:

SG 294/08



Start Date:

June 2009

Completion Date:

December 2011

Related Keywords:

  • Advanced Cancer
  • Cachexia
  • Adult
  • Cachexia
  • Neoplasms