MDACC Study Summary 2011-0559

Study Summary
No. 2011-0559:.......Leukemia......Jorge Cortes......Leukemia

Study Summary Title



Study Summary Number:	2011-0559

Study Title:	The Role of Tryptophan Metabolism in the Chronic Fatigue Experienced by Chronic Myeloid Leukemia (CML) Survivors

Physician

New Patient Referral



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

Dept:	Leukemia	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-794-5783 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	MDACC IRG

Phase of Study:	N/A	Return Visit:

Treatment Agents:	None	Home Care:

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:


Description/ Intervention:	The goal of this research study is to learn more about the quality of life of patients with CML who receive a TKI. Researchers want to learn if and how the breakdown of tryptophan (an amino acid found naturally in the body that may be affected by TKIs) is related to symptoms such as fatigue.

Study Objectives / Outcomes

The main objective of this pilot study is to measure the association of tryptophan degradation with fatigue and quality of life in chronic-phase chronic myeloid leukemia (CML) survivors. The study will include CML survivors who have received tyrosine kinase inhibitor (TKI) therapy for at least 12 months and have already achieved complete cytogenetic remission (CCyR). We will follow these CML survivors for an additional 6 months.

The primary aims of the study are:

1. To measure the degree of association between tryptophan degradation and fatigue over time in chronic phase CML survivors in CCyR undergoing TKI maintenance therapy.

2. To measure the degree of association between tryptophan degradation and quality of life over time in chronic phase CML survivors in CCyR undergoing TKI maintenance therapy.

The secondary aim of the study is:

1. To measure the degree of association between tryptophan degradation and the inflammatory markers NF-鵤, MAPK, C-reactive protein (CRP) and neopterin over time in chronic phase CML survivors in CCyR undergoing TKI maintenance therapy.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	09/07/2011

Study Type:	Behavioral

Recruitment Status:	Open

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 a current diagnosis of chronic-phase CML in complete remission confirmed by cytogenetic analysis

2) Have received TKI therapy with imatinib, nilotinib, or dasatinib for at least 12 months.

3) 18 years of age or older.

4) Have a usual fatigue score =/<1 or =/>5 (on a 0-10 scale) at the time of pre-screening.

5) Able to speak and read English or Spanish.

6) Able and willing to participate in interactive voice response (IVR) symptom assessments.

7) Able and willing to provide written informed consent.

8) Able and willing to be followed at MD Anderson at least 7 months from the day of informed consent.

Exclusion Criteria:

1) Active treatment (surgery, chemotherapy or radiotherapy) for a second malignancy.

2) Medical condition or impaired performance status that precludes participation in the study.

3) Diagnosis of severe depression, psychosis or severe cognitive impairment.

4) Recent history (within the last 30 days) of receiving any physician-prescribed, anti-inflammatory drug for the treatment of a chronic medical condition, including chronic pain. Over-the-counter pain medication will be allowed.

Links

Registration Number: Not Applicable Clinical Trial