MDACC Study Summary 2006-0515

Study Summary
No. 2006-0515:.......Blood And Marrow Transplantation; Leukemia; Lymphoma......Srisuda Lecagoonporn......Medical Oncology

Study Summary Title



Study Summary Number:	2006-0515

Study Title:	A Pilot Study to Evaluate a Nutritional Assessment Intervention to Improve Cancer-Related Fatigue among Post-Allogeneic Blood and Marrow Transplantation Recipients

Physician

New Patient Referral



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

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

Phone:	713-745-1000 Contact us about clinical trials

General Information



Disease Group:	Blood And Marrow Transplantation Leukemia Lymphoma	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	No extra return visits are required for subjects in this study. Researcher and dietitian will come to visit subjects in their treatment rooms on their scheduled dates at ambulatory treatment center for data collection, teaching, or dietary consults.

Treatment Agents:	None	Home Care:	Not applicable

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Not applicable


Description/ Intervention:	Unavailable

Study Objectives / Outcomes

Primary Objective:

To use the results from this pilot study to estimate the effect size of the nutritional intervention on fatigue and caloric intake

Secondary Objective:

To apply nutritional assessment tools for early detection of patients at risk for malnutrition.

To examine the feasibility of conducting this intervention study.

To describe cancer-related fatigue patterns among BMT patients at multiple time points during ambulatory visits.

To evaluate the effects of a nutritional intervention for post-allogeneic BMT recipients on adequacy of caloric intake in order to improve cancer-related fatigue scores.

Study Status Information



Study Activation / Registration Date:	09/14/2006

IRB Review and Approval Date:	08/24/2006

Study Type:	Observational

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) Subject has been diagnosed with cancer (leukemia or lymphoma).

2) Age 18 years or older

3) Subject has received their allogeneic BMT, fully ablative transplants, from either related or unrelated donors in the past 40 days

4) Subject can read, write, speak, and understand English

5) Subject has a caregiver (family member or friend) to keep the food diary record.

6) Subject voluntarily agrees and signs informed consent prior to participate in this study.

7) Subject is oriented to time, place, and person.

Exclusion Criteria:

1) Subject has major organ failure such as kidney, heart, or liver failure.

2) Subject has allergies to latex preventing use of the mouthpiece during indirect calorimetry testing.

3) Subject has been scheduled to withhold oral intake or parenteral nutrition support for more than 4 days during the week of dietary record (week 2, 4, and 6)

4) Subject has a diagnosis of gastro-intestinal graft versus host disease (GI-GVHD).

5) Subject has pre-transplant pulmonary function tests (PFTs) with force vital capacity (FVC) or forced expiratory volume in one second (FEV1) or diffusing capacity of the lung for carbon monoxide (DLCO) < 65% of predicted value.

6) Subject who is physically unable to complete the indirect calorimetry or who refuses calorimetry or who cannot understand the instructions.

Links

Registration Number: NCT00507260
Study Information on Clinical Trials Registry (clinicaltrials.gov)