The use of Thalidomide as a treatment for the cachexia of incurable upper gastrointestinal adenocarcinomas:a randomised, double-blinded, placebo controlled trial. - Thalidomide in cancer cachexia

Portsmouth Hospitals Trust0 个研究点目标入组 180 人开始时间: 2005年8月31日最近更新: 2019年11月25日

试验速览

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•·Have a histological or cytological diagnoisis of upper gastrointestinal adenocarcinoma.
•·Have no curative options available that are acceptable to the patient
•·Have a predicted survival of at least 4 weeks.
•·Aged over 18 years at the time to entry into the trial.
•·Able to understand the information given and to give written informed consent.
•·Able to take oral medications.
•·Agree to the conditions of use of Thalidomide as enumerated (see appendix)
•·Women under the age of 54, and those over 54 but still menstruating, must have a negative urinary pregnancy test and negative pregnancy tests repeated on a monthly basis until one month after completion of the trial
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•·Unable to provide informed consent
•·Involved in any other trial during the study period
•·Pregnant or breast feeding
•·Unable or considered unlikely to avoid pregnancy
•·Evidence of peripheral neuropathy, severe constipation, vertigo or vestibular disease
•·Unable to take oral medication
•·Previous adverse reaction to Thalidomide
•·Any condition which is judged by the investigator to make the patient unsuitable for inclusion into the study such as severe concurrent hepatic, renal, haematological, gastrointestinal, endocrine, neurological, pulmonary, or cardiac disease
•·Abnormal haematological or biochemical blood results at screening considered by the investigator to make the patient unsuitable for inclusion into the study.

发起方

Portsmouth Hospitals Trust