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

Phase 1

• Conditions: The cachexia associated with terminal gastrointestinal adenocarcinomas

• Registration Number: EUCTR2005-000371-18-GB
• Lead Sponsor: Portsmouth Hospitals Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-31
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 180

Inclusion Criteria

·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

Exclusion Criteria

·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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified