Nutritional Assessment Intervention to Improve Cancer-Related Fatigue
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00507260
First received: July 24, 2007
Last updated: September 26, 2012
Last verified: September 2012
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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 2014 (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.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Srisuda Lecagoonporn, RN | M.D. Anderson Cancer Center |
More Information
Additional Information:
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 26, 2012 |
| 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 May 19, 2013