Clinical Drug Experience Knowledgebase

Criteria

Inclusion:

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.
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.

Exclusion:

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.