Clinical trial · Interventional
A Mixed Methods Study of Nutrition Practice in Cancer Care on Non-Hodgkin Lymphoma Population
A Mixed Methods Study of Nutrition Practice in Cancer Care: Test a Newly-developed Intervention and Establish Frameworks Reflecting Multi-aspects of Eating Behavior Based on Non-Hodgkin Lymphoma Population
- 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)
The effects of calorie or sugar control on health and disease has been a hot topic. While established evidence has proven the health benefits of long-term calorie restriction, recent preclinical studies show encouraging results of the beneficial effects of short-term fasting on cancer treatment. In particular, short-term calorie control seems to be safe and has the potential to increase cancer cell's sensitivity to chemotherapy whereas protect normal cells from chemotherapy-induced toxicity. More human trials are needed before translating this intervention into clinical practice. The overall goal of this study is to examine if nutrition status and an intervention of sugar and calorie modification will affect patient outcomes in patients with diffuse large B-Cell lymphoma (DLBCL) receiving chemo therapy which includes Rituximab, Cyclophosphamide, Hydroxydaunomycin, Oncovin, and Prednisone(R-CHOP). This 5-year research project with three phases will be conducted at National Taiwan University Hospital. The first phase is a case control, observational study. By reviewing electronic charts of patients who (1) were newly diagnosed with DLBCL within the past 5 years, (2) received R-CHOP, (3) were 20-year-old or older at diagnosis, we seek to examine specific aim 1 and 2. About 500 cases are needed in this phase to achieve 80% power. The second phase is a pilot study requiring 50 participants to assess feasibility of the protocol. The third phase is a prospective cohort study in which the safety, feasibility, and effects of a calorie modification protocol are examined (aim 3, 4, and 5), participants will be randomized to experimental and comparison group. While comparison group will receive standard care, experimental group will follow the protocol of calorie modification.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, B-Cell | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Short-Term Calorie Reduction | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Short-Term Calorie Reduction(SCR)
- description
- To determine the short-term impact of calorie modification on patient outcomes by measuring and comparing the following parameters between two groups a week after starting each R-CHOP cycle: symptoms, hematologic parameters (i.e., erythrocyte-, thrombocytes-, and leucocyte counts), metabolic parameters (i.e., insulin, glucose, insulin growth factor 1), inflammatory response (C-reactive Protein, CRP), and nutrition status (i.e., weight, albumin level, and lean body mass (LBM)).
- interventionNames
- Dietary Supplement: Short-Term Calorie Reduction
- type
- NO_INTERVENTION
- label
- Control
- description
- Participated patients will be recruited and randomized to two groups: comparison group who receive standard care and experimental group who receive the SCR intervention. The standard care at NTUH includes encouraging patients to eat healthy and clean diet (e.g., avoid raw or undercooked food). There are no calorie restriction to the comparison group. The next paragraph describes the SCR intervention for experimental group.
Primary outcomes (14)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Newly diagnosed with DLBCL 2. Planning to receive R-CHOP regimen 3. 20-year-old or older 4. The targeted sample size is 50 for each group Exclusion Criteria: 1. Have BMI less than or equal to 18.5 2. Have albumin level lower than 3.4 g/liter 3. History of eating disorders 4. Have difficulties to follow the instructions of calorie modifications due to physiological or psychological condition 5. Have been diagnosed with diabetes mellitus or have physiological or psychological condition that calorie modification may cause negative effect on their physical or psychological status 6. Have special dietary restrictions
References
Publications (1)
- BACKGROUNDCathcart P, Craddock C, Stebbing J. Fasting: starving cancer. Lancet Oncol. 2017 Apr;18(4):431. doi: 10.1016/S1470-2045(17)30196-1. No abstract available. PMID 28368246