NCT00507260

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. 1.To apply nutritional assessment tools for early detection of patients at risk for malnutrition.
  2. 2.To examine the feasibility of conducting this intervention study.
  3. 3.To describe cancer-related fatigue patterns among BMT patients at multiple time points during ambulatory visits.
  4. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable leukemia

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable leukemia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2007

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 24, 2014

Status Verified

December 1, 2014

Enrollment Period

8.3 years

First QC Date

July 24, 2007

Last Update Submit

December 23, 2014

Conditions

LeukemiaLymphomaFatigue

Keywords

LeukemiaLymphomaPost-Allogeneic Blood and Marrow TransplantationBlood and Marrow TransplantationBMTCancer-Related FatigueFatigueNutritional AssessmentNutritional InterventionMalnutrition

Outcome Measures

Primary Outcomes (1)

  • Patient Fatigue Scores <Brief Fatigue Inventory (BFI)>

    BFI at study day 0, 14, 28, and 42

Study Arms (2)

Control Group

EXPERIMENTAL

Control Group (Food Record)

Behavioral: Food Record

Treatment Group

EXPERIMENTAL

Treatment Group (Food Record + Nutritional Consults)

Behavioral: Food RecordOther: Nutritional Consults

Interventions

Food RecordBEHAVIORAL

A record of the amount and kind of food and drink you intake will be completed.

Control GroupTreatment Group
Nutritional ConsultsOTHER

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

Treatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

LeukemiaLymphomaFatigueMalnutrition

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Srisuda Lecagoonporn, RN

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2007

First Posted

July 26, 2007

Study Start

September 1, 2006

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 24, 2014

Record last verified: 2014-12

Locations

US(1)