Lymphoma, B-CellNCT05376709
A Mixed Methods Study of Nutrition Practice in Cancer Care on Non-Hodgkin Lymphoma Population
A study testing Short-Term Calorie Reduction in people with Lymphoma, B-Cell, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lymphoma, B-Cell
- What is being tested?
- Short-Term Calorie Reduction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2020to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Newly diagnosed with DLBCL
- Planning to receive R-CHOP regimen
- 20-year-old or older
- The targeted sample size is 50 for each group
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
NTUH
Taipei
Chia-Chun Tang, Asst. Prof, (02)23123456 ext. 88436, chiatang@ntu.edu.tw
About this study
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
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.
Read the 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
- Being tested
- Short-Term Calorie Reduction
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-Term Calorie ReductionDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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)). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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).
Measured: 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.
Measured: Baseline and 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start1 Sep 2020
- Primary completion30 Nov 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, B-CellStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tai-Chung Huang, MD, Principal investigator, NTUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05376709
- Sponsor's protocol ID
- 201810112RIND
- Status last verified
- May 2023
- First submitted
- 24 Dec 2020
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28368246
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05376709
- Acronym / sponsor ID
- 201810112RIND
- Conditions
- Lymphoma, B-Cell
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short-Term Calorie Reduction(SCR) | Experimental | Dietary Supplement: Short-Term Calorie ReductionTo 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)). |
| 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Newly diagnosed with DLBCL
- Planning to receive R-CHOP regimen
- 20-year-old or older
- The targeted sample size is 50 for each group
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short-Term Calorie ReductionAlign 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. | Dietary supplement | Short-Term Calorie Reduction(SCR) |
Primary outcome
Change from baseline Symptoms at 4 weeks
Time frame: Baseline and 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.
Change from baseline Quality-of-Life at 4 weeks
Time frame: Baseline and 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.
Change from baseline Cell Toxicity at 4 weeks
Time frame: Baseline and 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.
Change from baseline Cell Toxicity at 4 weeks
Time frame: Baseline and 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.
Change from baseline Cell Toxicity at 4 weeks
Time frame: Baseline and 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.
Change from baseline Cell Metabolism at 4 weeks
Time frame: Baseline and 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.
Change from baseline Cell Metabolism at 4 weeks
Time frame: Baseline and 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).
Change from baseline Cell Metabolism at 4 weeks
Time frame: Baseline and 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).
Change from baseline Cell Metabolism at 4 weeks
Time frame: Baseline and 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.
Change from baseline Cell Inflammatory at 4 weeks
Time frame: Baseline and 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).
Change from baseline Nutrition Status at 4 weeks
Time frame: Baseline and 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).
Change from baseline Nutrition Status at 4 weeks
Time frame: Baseline and 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)
Change from baseline Nutrition Status at 4 weeks
Time frame: Baseline and 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).
Change from baseline PET/CT scan at 18 weeks
Time frame: Baseline and 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Background: PubMed 28368246Cathcart 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tai-Chung Huang, MD principal investigator
NTUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short-Term Calorie Reduction in people with Lymphoma, B-Cell, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chia-Chun Tang, Asst. Prof ((02)23123456 ext. 88436, chiatang@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Symptoms at 4 weeks (time frame: Baseline and 4 weeks). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05376709, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.