Clinical trial: Cyproheptadine and Megestrol in Preventing Weight Loss in Children With Cachexia Caused By Cancer or Cancer Treatment (NCT00066248)

Eligibility criteria:
INCLUSION CRITERIA:

          -  Any cachectic patient with weight loss presumed secondary to cancer or cancer related
             therapy is eligible. Cachexia is defined as having one or more of the following:

          -  documented history of weight loss > 5%

          -  drop in growth rate two or more percentile ranks on standard growth charts,

          -  weight for height less than the tenth percentile.

          -  Patients with newly diagnosed or relapsed cancer of any type, including brain tumors.

          -  Patients who are receiving active or palliative therapy are eligible.

          -  If patients have completed treatment for cancer (surgery, chemotherapy, radiotherapy)
             within 8 weeks of study registration, they are also eligible.

          -  Patients must be ≥ 2 years and < 21 years of age at the time of admission to this
             study.

          -  Patients must have a predicted life expectancy of at least eight weeks.

        EXCLUSION CRITERIA:

          -  Patients who are currently taking or who have taken Periactin and/or Megace during the
             past three weeks are not eligible.

          -  Patients receiving corticosteroid or monoamine oxidase (MAO) inhibitor therapy.
             (Intermittent steroid use is permitted IF you anticipate it will not be administered
             for more than 7 days in a 4 week period. Calculate anticipated intermittent steroid
             use in 4-week intervals through the 8-week period during which study agent may be
             administered (4 weeks for Periactin and potentially 4 weeks for Megace.

          -  Patients who have received parenteral nutrition or tube feedings within 1 week of
             starting this protocol or patients who are expected to require parenteral nutrition or
             tube feedings during the 4-week course of this study.

          -  Patients taking dronabinol (Marinol) or other appetite-stimulating medications during
             the past three weeks or patients expected to be prescribed appetite-stimulating
             medications during the 4-week course of this study.

          -  Patients with hormone sensitive tumors specifically meningiomas, breast cancer,
             ovarian cancer, and endometrial carcinoma.31, 32

          -  Children with neurofibromatosis, type I or II, are at risk for the development of
             meningiomas and are thus excluded from this study.32

          -  Children with glaucoma, chronic persistent asthma, or gastrointestinal (GI) or
             genitourinary (GU) obstruction.

          -  Patients with recurrent and/or persistent hypertension, defined as blood pressure
             values >20% above normal.

          -  Patients with thromboembolic disease, congestive heart failure, or peripheral edema.

          -  Patients who are pregnant.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 2 Years old.
Subject must be at most 20 Years

Patient description (medical language): A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands.

Patient description (patient's own words): I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated...

Does the patient match the trial criteria? Contradiction