Clinical trial NCT05376709: A Mixed Methods Study of Nutrition Practice in Cancer Care on Non-Hodgkin Lymphoma Population
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lymphoma, B-Cell
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: Background. 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.

Study purpose and aims. 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 R-CHOP. The specific aims are: (1) to investigate the demographic information and nutrition status (e.g., body mass index, albumin level, fasting sugar, and hyperglycemic episode) of patients with DLBCL before and during R-CHOP; (2) to examine the relationships between nutrition status and treatment outcomes of patients with DLBCL; (3) to evaluate the safety and feasibility of applying the protocol of calorie modification to patients with DLBCL undergoing R-CHOP; (4) to determine the short-term impacts 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), and nutrition status (i.e., weight, albumin level, and lean body mass); (5) to determine how calorie modification affects the therapeutic effects of R-CHOP by (a) using positron emission tomography and computed tomography (PET/CT scan) at three time points: before treatment, upon completion of the third cycle, and upon completion of the whole R-CHOP regimen and (b) following up with the progression-free-survival a year post treatment.

Methods and sampling. 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. The results of this phase will help finalize the calorie modification protocol and determine the sample size for the third phase which is a larger randomized controlled trial. For phase two and three, the inclusion criteria are patients who are (1) diagnosed with advanced DLBCL, (2) receiving R-CHOP regimen and do not have hypersensitivity reaction, and (3) 20-year-old or older.

Data analysis. Descriptive statistics, Pearson partial correlation, and multiple linear regression will be used to analyze relationship among interested variables. Independent-t test, paired t-test, and Mann-Whitney U test are selected to determine the differences between groups.

Expecting results. The current study is one among the first few translational research programs implementing calorie modification strategies in real practice. It is particularly valuable and innovative in terms of its comprehensive design, extensive scope, and focus of unexplored population. Results of the current study have a great potential to change current nutrition recommendations for cancer patients receiving chemotherapy and enhance evidence-based care.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline Symptoms at 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change from baseline Quality-of-Life at 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change from baseline Cell Toxicity at 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change from baseline Cell Toxicity at 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change from baseline Cell Toxicity at 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change from baseline Cell Metabolism at 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change from baseline Cell Metabolism at 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change from baseline Cell Metabolism at 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change from baseline Cell Metabolism at 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change from baseline Cell Inflammatory at 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change from baseline Nutrition Status at 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change from baseline Nutrition Status at 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change from baseline Nutrition Status at 4 weeks
timeFrame: Baseline and 4 weeks
measure: Change from baseline PET/CT scan at 18 weeks
timeFrame: Baseline and 18 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: NTUH
Study officials:
affiliation: NTUH
name: Tai-Chung Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cathcart 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.