The Effects of Thalidomide on Symptom Clusters - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Celgene Corporation
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00379353

Purpose

Primary Objectives:

To determine whether thalidomide given at low doses can improve the cancer cachexia symptom cluster, including anorexia, fatigue, weight loss and one of the following: anxiety, depression or sleep disturbances, in patients with advanced cancer as compared to placebo.
To explore the association between the serum level of cytokines [IL-1, IL-6, TNF-a, IFN], and the severity of the cancer cachexia cluster, including anorexia, fatigue, and one of the following: anxiety, depression or sleep disturbances.
To explore the effects of thalidomide on the body composition, and the resting energy expenditure.
To determine whether thalidomide given at low doses can improve other cancer related symptoms, including pain, depression, and sleep disorders.

Condition	Intervention	Phase
Advanced Cancers	Drug: Thalidomide Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Effects of Thalidomide on Symptom Clusters

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Cancer Depression Sleep Disorders

Drug Information available for: Thalidomide

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To learn if thalidomide can improve symptoms such as pain, fatigue, anxiety, poor appetite, depression, and sleep problems in patients with advanced cancer. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	62
Study Start Date:	September 2006
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: Active Comparator Thalidomide	Drug: Thalidomide 100 mg capsules orally, once a day for 14 days.
Group 2: Placebo Comparator Placebo	Drug: Placebo Two placebo capsules orally, once a day for 14 days.

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 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 </= 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 (lenolinamide).
Patients on investigational chemotherapy/agents.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379353

Locations

United States, Texas
U.T. M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Celgene Corporation

Investigators

Principal Investigator:

Eduardo Bruera, MD

U.T. M.D. Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Eduardo Bruera, MD/Chair )
Study ID Numbers:	2005-0980
Study First Received:	September 19, 2006
Last Updated:	September 15, 2009
ClinicalTrials.gov Identifier:	NCT00379353 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Advanced Cancers
Anorexia
Fatigue
Thalidomide
Placebo

Additional relevant MeSH terms:

Anti-Infective Agents
Thalidomide
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Immunosuppressive Agents
Angiogenesis Inhibitors

Pharmacologic Actions
Anti-Bacterial Agents
Neoplasms
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Leprostatic Agents

ClinicalTrials.gov processed this record on November 22, 2009