Nutritional Assessment Intervention to Improve Cancer-Related Fatigue

Completed · Not applicable

Conditions studied: Leukemia, Lymphoma, Fatigue

In brief

Primary Objective: 1\. To use the results from this pilot study to estimate the effect size of the nutritional intervention on fatigue and caloric intake. Secondary Objectives: 1. To apply nutritional assessment tools for early detection of patients at risk for malnutrition. 2. To examine the feasibility of conducting this intervention study. 3. To describe cancer-related fatigue patterns among BMT patients at multiple time points during ambulatory visits. 4. 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.

Key facts

Study ID

NCT00507260

Run by

M.D. Anderson Cancer Center

People needed

10

Starts

2006-09-01

Expected to finish

2014-12-01

Last updated by the study team

2014-12-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has been diagnosed with cancer (leukemia or lymphoma).
• Age 18 years or older
• Subject has received their allogeneic BMT, fully ablative transplants, from either related or unrelated donors in the past 40 days
• Subject can read, write, speak, and understand English
• Subject has a caregiver (family member or friend) to keep the food diary record.
• Subject voluntarily agrees and signs informed consent prior to participate in this study.
• Subject is oriented to time, place, and person.

You may not qualify if…

• Subject has major organ failure such as kidney, heart, or liver failure.
• Subject has allergies to latex preventing use of the mouthpiece during indirect calorimetry testing.
• 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)
• Subject has a diagnosis of gastro-intestinal graft versus host disease (GI-GVHD).
• 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.
• Subject who is physically unable to complete the indirect calorimetry or who refuses calorimetry or who cannot understand the instructions.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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