The Effects of Thalidomide on Symptom Clusters

NCT00379353 | Completed Phase 2 Results DMC

• 1 other identifier: 2005-0980
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Cancers

Keywords

Advanced Cancers; Anorexia; Fatigue; Thalidomide; Placebo

Outcome Measures

Primary Outcomes (1)

• Change in Symptoms as Measured by Edmonton Symptom Assessment Scale (ESAS)

  ESAS assessment of appetite (symptom) where the severity at the time of assessment is rated from 0 to 10 on a numerical scale; with 0 meaning that the symptom is absent and 10 that it is the worst possible severity. Evaluated at baseline \[± 3 days\], 2 weeks\[± 3 days\] and 4 weeks \[± 3 days\]

  Baseline to Day 29

Secondary Outcomes (7)

• Functional Assessment of Anorexia/Cachexia Therapy (FAACT)

  Baseline to Day 29

• Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)

  Baseline to Day 29

• Hospital Anxiety and Depression Scale (HADS) HADS-A (Anxiety)

  Baseline to Day 29

• Hospital Anxiety and Depression Scale (HADS) HADS-D (Depression)

  Baseline to Day 29

• Pittsburgh Sleep Quality Index (PSQI)

  Baseline to Day 29

Study Arms (2)

Group 1: Thalidomide

ACTIVE COMPARATOR

100 mg capsules orally, once a day for 14 days

Drug: Thalidomide

Group 2: Placebo

PLACEBO COMPARATOR

Two placebo capsules orally, once a day for 14 days.

Drug: Placebo

Interventions

Thalidomide DRUG

100 mg capsules orally, once a day for 14 days.

Group 1: Thalidomide

Placebo DRUG

Two placebo capsules orally, once a day for 14 days.

Group 2: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Celgene Corporation: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Anorexia; Fatigue

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Limited accrual and attrition led to small sample size.

Results Point of Contact

• Title: Dr. Eduardo Bruera, Professor
• Organization: University of Texas M.D. Anderson Cancer Center

ammarin@mdanderson.org

713-563-4157

Study Officials

• Eduardo Bruera, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2006
• First Posted: September 21, 2006
• Study Start: September 1, 2006
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: February 4, 2013
• Results First Posted: January 1, 2013

Record last verified: 2013-01

Locations

US (1)