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

NCT05376709 | Unknown

• 1 other identifier: 201810112RIND
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma, B-Cell

Outcome Measures

Primary Outcomes (14)

• Change from baseline Symptoms at 4 weeks

  European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire core 30. (EORCT-QLQ C30, Taiwan Chinese version) is a reliable and valid tool that a group of experts developed. EORCT-QLQ C30 consists of 30 items and measures patients' functions and symptoms by 4-point Likert scales. Higher scores for symptom scales represent more intense symptoms. Researchers use this measurement to assess the change in symptoms severity before and after chemotherapy.

  Baseline and 4 weeks

• Change from baseline Quality-of-Life at 4 weeks

  European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire core 30. (EORCT-QLQ C30, Taiwan Chinese version) measures quality-of-life (QoL) by 7-point Likert scales. The minimum and maximum values are 1 and 7, respectively. Higher scores for QoL mean better.

  Baseline and 4 weeks

• Change from baseline Cell Toxicity at 4 weeks

  To determine the change of short-term impact of calorie modification on patient outcomes by measuring and comparing the hematologic parameters between two groups. The blood sample would be erythrocyte- counts.

  Baseline and 4 weeks

• Change from baseline Cell Toxicity at 4 weeks

  To determine the change of short-term impact of calorie modification on patient outcomes by measuring and comparing the hematologic parameters between two groups. The blood sample would be thrombocytes- counts.

  Baseline and 4 weeks

• Change from baseline Cell Toxicity at 4 weeks

  To determine the change of short-term impact of calorie modification on patient outcomes by measuring and comparing the hematologic parameters between two groups. The blood sample would be leucocyte counts.

  Baseline and 4 weeks

• Change from baseline Cell Metabolism at 4 weeks

  To determine the change of short-term impact of calorie modification on patient outcomes by measuring and comparing the metabolic parameters between two groups. The blood sample would be insulin.

  Baseline and 4 weeks

• Change from baseline Cell Metabolism at 4 weeks

  To determine the change of short-term impact of calorie modification on patient outcomes by measuring and comparing the metabolic parameters between two groups. The blood sample would be glucose (before meals).

  Baseline and 4 weeks

• Change from baseline Cell Metabolism at 4 weeks

  To determine the change of short-term impact of calorie modification on patient outcomes by measuring and comparing the metabolic parameters between two groups. The blood sample would be insulin growth factor-1(IGF-1).

  Baseline and 4 weeks

• Change from baseline Cell Metabolism at 4 weeks

  To determine the change of short-term impact of calorie modification on patient outcomes by measuring and comparing the metabolic parameters between two groups. The blood sample would be prealbumin.

  Baseline and 4 weeks

• Change from baseline Cell Inflammatory at 4 weeks

  To determine the change of short-term impact of calorie modification on patient outcomes by measuring and comparing the inflammatory parameters between two groups. The blood sample would be like inflammatory response (C-reactive Protein, CRP).

  Baseline and 4 weeks

• Change from baseline Nutrition Status at 4 weeks

  To determine the short-term impact of calorie modification on patient outcomes by measuring nutrition status with the Inbody S10 Body Water Analyzer machine (i.e., extracellular water).

  Baseline and 4 weeks

• Change from baseline Nutrition Status at 4 weeks

  To determine the short-term impact of calorie modification on patient outcomes by measuring nutrition status with the Inbody S10 Body Water Analyzer machine (i.e., phase angle)

  Baseline and 4 weeks

• Change from baseline Nutrition Status at 4 weeks

  To determine the short-term impact of calorie modification on patient outcomes by measuring nutrition status with the Inbody S10 Body Water Analyzer machine (i.e., skeletal muscle mass index, SMI).

  Baseline and 4 weeks

• Change from baseline PET/CT scan at 18 weeks

  After 6 times chemotherapy, the PET/CT scan will be used to assess the tumor completely response, partially response or progressed compared to the first diagnosed one.

  Baseline and 18 weeks

Study Arms (2)

Short-Term Calorie Reduction(SCR)

EXPERIMENTAL

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)).

Dietary Supplement: Short-Term Calorie Reduction

Control

NO INTERVENTION

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.

Interventions

Short-Term Calorie Reduction 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.

Short-Term Calorie Reduction(SCR)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed with DLBCL
• Planning to receive R-CHOP regimen
• year-old or older
• The targeted sample size is 50 for each group

You may not qualify if:

• Have BMI less than or equal to 18.5
• Have albumin level lower than 3.4 g/liter
• History of eating disorders
• Have difficulties to follow the instructions of calorie modifications due to physiological or psychological condition
• 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
• Have special dietary restrictions

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

NTUH

Taipei, Taiwan

RECRUITING

Related Publications (1)

• 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.

  PMID: 28368246 BACKGROUND

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Tai-Chung Huang, MD

  NTUH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chia-Chun Tang, Asst. Prof

CONTACT

(02)23123456; chiatang@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2020
• First Posted: May 17, 2022
• Study Start: September 1, 2020
• Primary Completion: November 30, 2023
• Study Completion: January 1, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)