The Effects of Thalidomide on Symptom Clusters
Condition: Advanced Cancers
MeSH terms: Syndrome
Intervention: Thalidomide; Placebo
Intervention description: 100 mg capsules orally, once a day for 14 days.; Two placebo capsules orally, once a day for 14 days.
Intervention MeSH terms: Thalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Cancers; Anorexia; Fatigue; Thalidomide; Placebo

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have weight loss of > 5% within the last 6 months

          2. 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.

          3. Describe the symptoms as being present every day for a minimum of 2 weeks.

          4. Have no clinical evidence of cognitive failure

          5. Must be 18 years or older.

          6. Expect to live at least >/= 4 weeks

          7. 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.

          8. Understand and sign written informed consent.

          9. Have no concurrent steroids with the exception of steroids used concurrently with
             chemotherapy as part of a regimen or to reduce nausea.

         10. Willing and able to comply with S.T.E.P.S.[System for Thalidomide Education and
             Prescribing Safety]

         11. Patient's Absolute neutrophil count (ANC) at time of study enrollment is >/= 750 mm
             (to be drawn within 14 days prior to registration)

         12. May be on chemotherapy if at a stable dose. Targeted therapies or hormone therapies
             are permitted once patient has completed two weeks of treatment.

        Exclusion Criteria:

          1. Have major contraindication to thalidomide, i.e. hypersensitivity.

          2. Present with National Cancer Institute (NCI) Common Toxicity Criteria Grade 3 or more
             peripheral neuropathy.

          3. Are not able to complete the baseline assessment forms.

          4. Are pregnant or lactating.

          5. Patients with clinical history of seizures

          6. Patients with an ANC of </= 750 at time of study enrollment will be excluded (to be
             drawn within 14 days prior to registration).

          7. 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).

          8. Patients on Revlimid (lenalidomide).

          9. Patients on investigational chemotherapy/agents.