A Mixed Methods Study of Nutrition Practice in Cancer Care on Non-Hodgkin Lymphoma Population

NCT ID: NCT05376709

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2024-01-01

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.

Conditions

Lymphoma, B-Cell

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Short-Term Calorie Reduction(SCR)

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)).

Group Type: EXPERIMENTAL

Short-Term Calorie Reduction

Intervention Type: DIETARY_SUPPLEMENT

Align with the R-CHOP regimen, patients in the experimental group will first perform water fast 24 hours before (day 0) and during the first day of R-CHOP (day 1) when they receive Rituximab, Vincristine, Doxorubicin, cyclophosphamide, and prednisolone. On day 2, they will resume normal calorie intake until the day before the next cycle of chemotherapy. While each cycle of R-CHOP takes 21 days, most patients will receive a total of 6-8 cycles over four to six months.

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Short-Term Calorie Reduction

Align with the R-CHOP regimen, patients in the experimental group will first perform water fast 24 hours before (day 0) and during the first day of R-CHOP (day 1) when they receive Rituximab, Vincristine, Doxorubicin, cyclophosphamide, and prednisolone. On day 2, they will resume normal calorie intake until the day before the next cycle of chemotherapy. While each cycle of R-CHOP takes 21 days, most patients will receive a total of 6-8 cycles over four to six months.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tai-Chung Huang, MD

Role: PRINCIPAL_INVESTIGATOR

NTUH

Locations

NTUH

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chia-Chun Tang, Asst. Prof

Role: CONTACT

chiatang@ntu.edu.tw

(02)23123456 ext. 88436

Facility Contacts

Chia-Chun Tang, Asst. Prof

Role: primary

chiatang@ntu.edu.tw

(02)23123456 ext. 88436

References

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.

Reference Type: BACKGROUND

PMID: 28368246 (View on PubMed)

Other Identifiers

201810112RIND

Identifier Type: -

Identifier Source: org_study_id