The Effects of Thalidomide on Symptom Clusters

Completed · Phase 2 · Has a placebo group

Conditions studied: Advanced Cancers

In brief

The goal of this clinical research study is to learn if thalidomide can improve symptoms such as pain, fatigue,anxiety, poor appetite, depression, and sleep problems in patients with advanced cancer.

Key facts

Study ID: NCT00379353
Run by: M.D. Anderson Cancer Center
People needed: 32
Starts: 2006-09-01
Expected to finish: 2013-01-01
Last updated by the study team: 2013-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Have weight loss of > 5% within the last 6 months
Present with anorexia, fatigue and one of the following: anxiety, depression or sleep disturbances, during the preceding 24 hours, with an average intensity of each symptom >/= 3 on a scale of 0 to 10, in which 0=no symptom, and 10= the worst possible symptom.
Describe the symptoms as being present every day for a minimum of 2 weeks.
Have no clinical evidence of cognitive failure
Must be 18 years or older.
Expect to live at least >/= 4 weeks
Must have negative serum pregnancy test within 24 hours of study enrollment in women of childbearing potential. FDA criteria for the status of not of childbearing potential, hysterectomy, or menopausal for 24 consecutive months.
Understand and sign written informed consent.
Have no concurrent steroids with the exception of steroids used concurrently with chemotherapy as part of a regimen or to reduce nausea.
Willing and able to comply with S.T.E.P.S.[System for Thalidomide Education and Prescribing Safety]
Patient's Absolute neutrophil count (ANC) at time of study enrollment is >/= 750 mm (to be drawn within 14 days prior to registration)
May be on chemotherapy if at a stable dose. Targeted therapies or hormone therapies are permitted once patient has completed two weeks of treatment.

You may not qualify if…

Have major contraindication to thalidomide, i.e. hypersensitivity.
Present with National Cancer Institute (NCI) Common Toxicity Criteria Grade 3 or more peripheral neuropathy.
Are not able to complete the baseline assessment forms.
Are pregnant or lactating.
Patients with clinical history of seizures
Patients with an ANC of </= 750 at time of study enrollment will be excluded (to be drawn within 14 days prior to registration).
Patients with a history of Acquired Immune Deficiency Syndrome (AIDS), systemic lupus erythematous, or renal failure as defined by a serum creatinine of > 2.0 mg/dl at baseline will be excluded (to be drawn within 29 days prior to registration).
Patients on Revlimid (lenalidomide).
Patients on investigational chemotherapy/agents.

Where it is running

UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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