MDACC Study Summary 2005-0816

Study Summary
No. 2005-0816:.......Advanced Cancers......Sriram Yennurajalingam......Palliative Care & Rehabilitation Medicine

Study Summary Title



Study Summary Number:	2005-0816

Study Title:	The Effect of Dexamethasone on Symptoms in Patients with Advanced Cancer

Physician

New Patient Referral



Name:	Sriram Yennurajalingam	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:	5 outpatient visits

Treatment Agents:	Dexamethasone	Home Care:	If the patient requests, blood draws for Day 8, 15, 22, or 29 can be done at the patient's home by the Research Nurse.

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to learn if dexamethasone can help to control symptoms such as fatigue, pain, nausea, weight loss, loss of appetite, sleep problems, and/or depression in patients with advanced cancer.

Study Objectives / Outcomes

· Primary: To determine the effect of Dexamethasone on the intensity of Fatigue
· Secondary objective-1: To determine the effect of Dexamethasone on the intensity of Pain, anorexia and nausea.
· Secondary objective-2: To determine the changes in cytokines (IL-1, IL-6, TNF- alpha,IL-10, IL-8, activated monocytes and corresponding receptor levels) and C-reactive protein before and after treatment with dexamethasone.
· Secondary objective-3: To determine association of cytokines (IL-1, IL-6, TNF- alpha,IL-10, IL-8, activated monocytes and corresponding receptor levels) and C-reactive protein and Fatigue, Pain, Anorexia and nausea.
Secondary objective – 4: To collect pilot data on the quality of sleep and cortisol levels in ten subjects

Study Status Information



Study Activation / Registration Date:	02/28/2006

IRB Review and Approval Date:	12/07/2005

Study Type:	Not Applicable

Recruitment Status:	Closed

Projected Accrual:	160

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) Present with 3 or more symptoms during the last 24 hours (Pain, fatigue, chronic nausea, and anorexia/cachexia, sleep problems, depression or poor appetite), with an average intensity of >/= 4 on a 0-10 scale, in which 0= no symptom, and 10= worst possible symptom,

2) No clinical evidence of cognitive failure as evidenced by MDAS score of 13 or less at baseline

3) Must be 18 years of older

4) No longer a candidate for aggressive anticancer therapy-such as receptor blockers (Iressa, etc.) Patients on oral or palliative chemotherapy are eligible for study if approved by primary oncologist prior to inclusion. Patients who are receiving IV chemotherapy are eligible for study if approved by primary oncologist and they have completed 1st line of chemotherapy and are deemed stable by primary oncologist. The PI of this study will obtain and document approval from the primary oncologist in the patient's study documents.

5) Life expectancy =/> 30 days

6) Must understand and sign written informed consent

7) Patients on topical, or inhaled corticosteroids are eligible for study. If patients have been on oral corticosteroids for </= 7 days prior to inclusion of study they are eligible for study.

Exclusion Criteria:

1) Allergy to Dexamethasone

2) Inability to complete the baseline assessment forms

3) Patients currently taking Megestrol, and not off drug for > 7 days

4) Anemia as defined as < 9 hemoglobin

5) Known history of HIV

6) Neutropenia as defined by an absolute neutrophil count (ANC) of < 1500 cells/mm

7) Patients with a history of diabetes will be excluded.

8) All major surgeries such as thoractomy etc., that requires wound healing within last 2 weeks

9) Those who are currently receiving oral corticosteroid therapy or who have been on corticosteroid therapy >/= 8 days prior to study inclusion

10) Sepsis and/or acute, chronic, or ongoing infections

Links

Registration Number: NCT00489307
Study Information on Clinical Trials Registry (clinicaltrials.gov)