Phase 2
N=31
The Effects of Thalidomide on Symptom Clusters
Advanced Cancers
Bottom Line
View on ClinicalTrials.gov: NCT00379353 ↗Enrolled (actual)
31
Serious AEs
12.9%
Results posted
Jan 2013
Primary outcome: Primary: Change in Symptoms as Measured by Edmonton Symptom Assessment Scale (ESAS) — 3; 3; 4; 3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Thalidomide (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Symptoms as Measured by Edmonton Symptom Assessment Scale (ESAS) |
3; 3; 4; 3; 6.5; 2.5 | — |
| SECONDARY Functional Assessment of Anorexia/Cachexia Therapy (FAACT) |
22.5; 22.5; 32; 28; 25; 27 | — |
| SECONDARY Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) |
21; 20; 24.5; 24; 16; 24 | — |
| SECONDARY Hospital Anxiety and Depression Scale (HADS) HADS-A (Anxiety) |
9; 7; 9; 4; 6; 6.5 | — |
| SECONDARY Hospital Anxiety and Depression Scale (HADS) HADS-D (Depression) |
10; 8; 8; 8.5; 8; 6.59 | — |
| SECONDARY Pittsburgh Sleep Quality Index (PSQI) |
9.5; 11; 10.5; 8.5; 8; 8 | — |
| SECONDARY Change in Body Composition as Measured by Body Mass Index (BMI) |
21.1; 21.2; 23.4; 22.3; 23.7; 22.1 | — |
| SECONDARY Change in Serum Cytokines and Receptors |
54.1; 85; 76.4; -6.51; 0.52; 0.67 | — |
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
- 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.
Exclusion Criteria
- 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 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.
Data sourced from ClinicalTrials.gov (NCT00379353). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.