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