MDACC Study Summary 2005-0980

Study Summary
No. 2005-0980:.......Advanced Cancers......Eduardo Bruera......Palliative Care & Rehabilitation Medicine

Study Summary Title



Study Summary Number:	2005-0980

Study Title:	The Effects of Thalidomide on Symptom Clusters

Physician

New Patient Referral



Name:	Eduardo Bruera	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Palliative Care & Rehabilitation Medicine	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-6085 Contact us about clinical trials

General Information



Disease Group:	Advanced Cancers	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	4

Treatment Agents:	Thalidomide	Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	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.

Study Objectives / Outcomes

1. 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.
2. To explore the association between the serum level of cytokines [IL-1, IL-6, TNF-á, IL-10, IL-8 ] and their receptors, and the severity of the cancer cachexia cluster, including anorexia, fatigue, and one of the following: anxiety, depression or sleep disturbances.
3. To explore the effects of thalidomide on the body composition, and the resting energy expenditure.
4. To determine whether thalidomide given at low doses can improve other cancer related symptoms, including pain, depression, and sleep disorders.

Study Status Information



Study Activation / Registration Date:	09/12/2006

IRB Review and Approval Date:	05/03/2006

Study Type:	Other

Recruitment Status:	Closed

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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 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 (lenolinamide).

9) Patients on investigational chemotherapy/agents.

Links

Registration Number: NCT00379353
Study Information on Clinical Trials Registry (clinicaltrials.gov)