Clinical trial · Interventional
Nutritional Assessment Intervention to Improve Cancer-Related Fatigue
A Pilot Study to Evaluate a Nutritional Assessment Intervention to Improve Cancer-Related Fatigue Among Post-Allogeneic Blood and Marrow Transplantation Recipients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Food Record | Behavioral | — | UNRESOLVED |
| Nutritional Consults | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Control Group
- description
- Control Group (Food Record)
- interventionNames
- Behavioral: Food Record
- type
- EXPERIMENTAL
- label
- Treatment Group
- description
- Treatment Group (Food Record + Nutritional Consults)
- interventionNames
- Behavioral: Food Record
- Other: Nutritional Consults
Primary outcomes (1)
- measure
- Patient Fatigue Scores <Brief Fatigue Inventory (BFI)>
- timeFrame
- BFI at study day 0, 14, 28, and 42
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available