Nutritional Assessment Intervention to Improve Cancer-Related Fatigue

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00507260
Recruitment Status : Completed
First Posted : July 26, 2007
Last Update Posted : December 24, 2014
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Fatigue Behavioral: Food Record Other: Nutritional Consults Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate a Nutritional Assessment Intervention to Improve Cancer-Related Fatigue Among Post-Allogeneic Blood and Marrow Transplantation Recipients
Study Start Date : September 2006
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arm Intervention/treatment
Experimental: Control Group
Control Group (Food Record)
Behavioral: Food Record
A record of the amount and kind of food and drink you intake will be completed.

Experimental: Treatment Group
Treatment Group (Food Record + Nutritional Consults)
Behavioral: Food Record
A record of the amount and kind of food and drink you intake will be completed.

Other: Nutritional Consults
Meeting with a dietician consultant regarding issues related to food intake. Participants will also receive the results from the food records.

Primary Outcome Measures :
  1. Patient Fatigue Scores <Brief Fatigue Inventory (BFI)> [ Time Frame: BFI at study day 0, 14, 28, and 42 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00507260

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Srisuda Lecagoonporn, RN M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00507260     History of Changes
Other Study ID Numbers: 2006-0515
First Posted: July 26, 2007    Key Record Dates
Last Update Posted: December 24, 2014
Last Verified: December 2014

Keywords provided by M.D. Anderson Cancer Center:
Post-Allogeneic Blood and Marrow Transplantation
Blood and Marrow Transplantation
Cancer-Related Fatigue
Nutritional Assessment
Nutritional Intervention

Additional relevant MeSH terms:
Signs and Symptoms