Nutritional Assessment Intervention to Improve Cancer-Related Fatigue - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00507260

Purpose

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:

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.

Condition	Intervention
Leukemia Lymphoma Fatigue	Behavioral: Food Record Other: Nutritional Consults

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Bone Marrow Transplantation Cancer Fatigue Leukemia Lymphoma Malnutrition

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Patient Fatigue Scores <Brief Fatigue Inventory (BFI)> [ Time Frame: BFI at study day 0, 14, 28, and 42 ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	September 2006
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00507260

Locations

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Srisuda Lecagoonporn, RN

M.D. Anderson Cancer Center

More Information

Additional Information:

MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00507260 History of Changes
Other Study ID Numbers:	2006-0515
Study First Received:	July 24, 2007
Last Updated:	September 21, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Leukemia
Lymphoma
Post-Allogeneic Blood and Marrow Transplantation
Blood and Marrow Transplantation
BMT

Cancer-Related Fatigue
Fatigue
Nutritional Assessment
Nutritional Intervention
Malnutrition

Additional relevant MeSH terms:

Fatigue
Leukemia
Lymphoma
Signs and Symptoms
Neoplasms by Histologic Type

Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012