NeoplasmsPhase 1NCT04626843
Intermittent Fasting and CLL/SLL
A Phase 1 study testing Intermittent fast in people with Neoplasms and Leukemia, Lymphocytic, Chronic, run by Eleah Stringer at 1 site in Canada.
Trial summary
What are the investigators trying to do? By most measures, humans consume more food than needed. Over several decades, overconsumption has led to an increase in a number of diseases, including cancer. Read more about this study
- Who is it for?
- Ages 19 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Neoplasms, Leukemia, Lymphocytic, Chronic, Lymphoma, Small Lymphocytic
- What is being tested?
- Intermittent fast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 3 Feb 2021to 31 Dec 2022
- Phase
- Phase 1
- 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 19 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of CLL or SLL
- Age </=85
- Lymphocytes >/=40 and <150
- Hemoglobin >/=100g/L
- Platelet >100 x 10*9/L
- BMI of >/= 20kg/m2
Show all 9Show fewer
- Eastern Cooperative Oncology Group (ECOG) Performance Status </=2
- Not on anti-lymphoma therapy within the past 3 months
- Not receiving anti-lymphoma therapy and not expected to require initiation of anti-lymphoma therapy within the next 3 months
Who cannot join
- Patient unable to give consent
- Patient on medications required to be taken with food during the fasting window
- Pregnancy
- Diabetes mellitus
- BMI drop to </= 18.5kg/m2 at any time during study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of Intermittent Fasting in Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (CLL/SLL) Patients at BC Cancer- Victoria
What are the investigators trying to do? By most measures, humans consume more food than needed. Over several decades, overconsumption has led to an increase in a number of diseases, including cancer. What if this could be reversed, or slowed down, by fasting? Would that improve how cancer patients respond to chemotherapy? Could simply changing eating patterns to reduce overall intake be a way to prevent and/or manage cancer? All of these are important questions and the investigators are undertaking a new initiative to study how nutrition and dietary behaviours affect cancer patients.
Fasting: A way to improve overall health and increase our defenses to cancer Fasting in various forms has been shown to have a number of health benefits. Intermittent fasting, or time restricted feeding, has been shown to reverse or improve various diseases such as diabetes, heart disease and metabolic syndrome, decrease the risk of cancer, and significantly extend the life of an individual. In previous studies, fasting was well-tolerated with notable improvements in energy levels, sense of well-being, and sleep quality. In cancer patients, clinical trials have demonstrated intermittent fasting to lessen some of the short-term side effects of chemotherapy such as nausea, fatigue, and sleep quality. How fasting alters the course of cancer or improve immune defenses is not yet known but may be an alternative way to treat or manage cancer.
Read more
The study plan The investigators plan to examine the effects of intermittent fasting (time restricted feeding) in patients with chronic lymphocytic leukemia (CLL). CLL is the most common chronic leukemia and is presently incurable. The advantage of choosing this patient population is that the cancer is easily assessed with a blood test measuring the amount of cancerous white cells (lymphocytes). Patients who consent to participate in this study will, through the support of an oncology dietitian and after a period of transition, split their daily feeding into a fasting period and a non-fasting period. This regime is as simple as skipping or having a late breakfast. At this time, participants will not be required to limit their total caloric intake.
What is required from the participant? The investigators will assess whether intermittent fasting reduces the cancer by measuring the lymphocyte count in the blood over a period of 3 months. Study participants will complete questionnaires to help determine if fasting causes any change in their quality of life. The effects of intermittent fasting on a cancer control system called autophagy, as well as its effects on inflammation will be studied in the Deeley Research Centre laboratory at BC Cancer.
What is the short- and long-term impact? In the short-term, if intermittent fasting can have an effect cancer lymphocyte count or on autophagy, then investigators will proceed with further studies to try and optimize the effects of intermittent fasting. In the long-term, this study is expected to be the first-ever to shed light on how intermittent fasting may be linked to cancer survival and/or growth. If true, this will open up new avenues to re-evaluate the inclusion of diet into cancer treatment protocols.
- Conditions
- Neoplasms, Leukemia, Lymphocytic, Chronic, Lymphoma, Small Lymphocytic, Intermittent Fasting, Diet Habit, Inflammation
- Being tested
- Intermittent fast
- Medical subject headings
- Neoplasms, Leukemia, Lymphocytic, Chronic, B-Cell, Intermittent Fasting, Feeding Behavior, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent fastOther
16/8 fasting method: fast for 16 hours of the day with an 8 hours feeding window for a duration of 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent fasting | Experimental | Not described Receives: Other: Intermittent fast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lymphocyte count
Changes in lymphocyte count will be measured between each peripheral blood draw.
Measured: Within 3 months pre-intervention, monthly during intervention, 1 month post-intervention
Change in quality of life
A quality of life questionnaire, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Cancer 30 (EORTC QLQ-C30) version 3, will be administered to assess to subjective changes in well-being. It comprises 30 items (i.e. single questions), 24 of which are aggregated into nine multi-item scales, that is, five functioning scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and one global health status scale. The remaining six single-item scales assess symptoms. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient).
Measured: Pre-intervention, day 90 of intervention, 1 month post-intervention
Change in inflammation
Changes in c-reactive protein (CRP) will be measured between each peripheral blood draw.
Measured: Within 3 months pre-intervention, monthly during intervention, 1 month post-intervention
Change in metabolic profiles
Changes in metabolomic profiles will be measured between each peripheral blood draw.
Measured: Within 3 months pre-intervention, monthly during intervention, 1 month post-intervention
Change in autophagy status
This includes standard flow cytometric analysis of lymphocyte subsets: a panel established by the Human Immunology Consortium Project as well as additional in-house markers to enumerate the frequency of lymphocytes before and at various time points post-treatment. The extent of autophagy will be tested by performing cytometry and western blotting assays using LC3II and p62 as readouts. Total cell counts in different lymphocyte subsets including, but not limited to, cluster of differentiation (CD) 3, CD8, CD4, CD20, CD19, and forkhead box P3 (FoxP3) will be assayed in conjugation with glucose uptake and mitochondrial function.
Measured: Within 3 months pre-intervention, monthly during intervention, 1 month post-intervention
Immune cell gene expression profiles
Expression profiles of selected immune cell genes
Measured: Within 3 months pre-intervention, monthly during intervention, 1 month post-intervention
Secondary outcomes (1)
Change in gut microbiome (optional)
Stool samples to identify baseline and fasting-induced changes in abundance and repertoire of the gut microbiota
Measured: 1 month pre-intervention, day 30 of intervention, day 90 of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start3 Feb 2021
- Primary completion30 Oct 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eleah Stringer
- Sponsor type
- University, hospital or other
- Collaborators
- BC Cancer Foundation
- Responsible party
- Sponsor-investigator, Eleah Stringer, British Columbia Cancer Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626843
- Sponsor's protocol ID
- H19-03702
- Status last verified
- Feb 2023
- First submitted
- 30 Sep 2020
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Intermittent Fasting in Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (CLL/SLL) Patients at BC Cancer- Victoria
- ClinicalTrials.gov ID
- NCT04626843
- Acronym / sponsor ID
- H19-03702
- Conditions
- Neoplasms, Leukemia, Lymphocytic, Chronic, Lymphoma, Small Lymphocytic, Intermittent Fasting, Diet Habit, Inflammation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Eleah StringerUniversity, hospital or other
- Collaborators
- BC Cancer Foundation
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 13 Nov 2020 (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.
What are the investigators trying to do? By most measures, humans consume more food than needed. Over several decades, overconsumption has led to an increase in a number of diseases, including cancer. What if this could be reversed, or slowed down, by fasting? Would that improve how cancer patients respond to chemotherapy? Could simply changing eating patterns to reduce overall intake be a way to prevent and/or manage cancer? All of these are important questions and the investigators are undertaking a new initiative to study how nutrition and dietary behaviours affect cancer patients.
Fasting: A way to improve overall health and increase our defenses to cancer Fasting in various forms has been shown to have a number of health benefits. Intermittent fasting, or time restricted feeding, has been shown to reverse or improve various diseases such as diabetes, heart disease and metabolic syndrome, decrease the risk of cancer, and significantly extend the life of an individual. In previous studies, fasting was well-tolerated with notable improvements in energy levels, sense of well-being, and sleep quality. In cancer patients, clinical trials have demonstrated intermittent fasting to lessen some of the short-term side effects of chemotherapy such as nausea, fatigue, and sleep quality. How fasting alters the course of cancer or improve immune defenses is not yet known but may be an alternative way to treat or manage cancer.
The study plan The investigators plan to examine the effects of intermittent fasting (time restricted feeding) in patients with chronic lymphocytic leukemia (CLL). CLL is the most common chronic leukemia and is presently incurable. The advantage of choosing this patient population is that the cancer is easily assessed with a blood test measuring the amount of cancerous white cells (lymphocytes). Patients who consent to participate in this study will, through the support of an oncology dietitian and after a period of transition, split their daily feeding into a fasting period and a non-fasting period. This regime is as simple as skipping or having a late breakfast. At this time, participants will not be required to limit their total caloric intake.
What is required from the participant? The investigators will assess whether intermittent fasting reduces the cancer by measuring the lymphocyte count in the blood over a period of 3 months. Study participants will complete questionnaires to help determine if fasting causes any change in their quality of life. The effects of intermittent fasting on a cancer control system called autophagy, as well as its effects on inflammation will be studied in the Deeley Research Centre laboratory at BC Cancer.
What is the short- and long-term impact? In the short-term, if intermittent fasting can have an effect cancer lymphocyte count or on autophagy, then investigators will proceed with further studies to try and optimize the effects of intermittent fasting. In the long-term, this study is expected to be the first-ever to shed light on how intermittent fasting may be linked to cancer survival and/or growth. If true, this will open up new avenues to re-evaluate the inclusion of diet into cancer treatment protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intermittent fasting | Experimental | Other: Intermittent fast |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of CLL or SLL
- Age </=85
- Lymphocytes >/=40 and <150
- Hemoglobin >/=100g/L
- Platelet >100 x 10*9/L
Key exclusion criteria (5 listed)
- Patient unable to give consent
- Patient on medications required to be taken with food during the fasting window
- Pregnancy
- Diabetes mellitus
- BMI drop to </= 18.5kg/m2 at any time during study
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 |
|---|---|---|
| Intermittent fast16/8 fasting method: fast for 16 hours of the day with an 8 hours feeding window for a duration of 3 months. | Other | Intermittent fasting |
Primary outcome
Change in lymphocyte count
Time frame: Within 3 months pre-intervention, monthly during intervention, 1 month post-intervention
Changes in lymphocyte count will be measured between each peripheral blood draw.
Change in quality of life
Time frame: Pre-intervention, day 90 of intervention, 1 month post-intervention
A quality of life questionnaire, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Cancer 30 (EORTC QLQ-C30) version 3, will be administered to assess to subjective changes in well-being. It comprises 30 items (i.e. single questions), 24 of which are aggregated into nine multi-item scales, that is, five functioning scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and one global health status scale. The remaining six single-item scales assess symptoms. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient).
Change in inflammation
Time frame: Within 3 months pre-intervention, monthly during intervention, 1 month post-intervention
Changes in c-reactive protein (CRP) will be measured between each peripheral blood draw.
Change in metabolic profiles
Time frame: Within 3 months pre-intervention, monthly during intervention, 1 month post-intervention
Changes in metabolomic profiles will be measured between each peripheral blood draw.
Change in autophagy status
Time frame: Within 3 months pre-intervention, monthly during intervention, 1 month post-intervention
This includes standard flow cytometric analysis of lymphocyte subsets: a panel established by the Human Immunology Consortium Project as well as additional in-house markers to enumerate the frequency of lymphocytes before and at various time points post-treatment. The extent of autophagy will be tested by performing cytometry and western blotting assays using LC3II and p62 as readouts. Total cell counts in different lymphocyte subsets including, but not limited to, cluster of differentiation (CD) 3, CD8, CD4, CD20, CD19, and forkhead box P3 (FoxP3) will be assayed in conjugation with glucose uptake and mitochondrial function.
Immune cell gene expression profiles
Time frame: Within 3 months pre-intervention, monthly during intervention, 1 month post-intervention
Expression profiles of selected immune cell genes
1 secondary outcome
Change in gut microbiome (optional)
Time frame: 1 month pre-intervention, day 30 of intervention, day 90 of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intermittent fast in people with Neoplasms and Leukemia, Lymphocytic, Chronic, run by Eleah Stringer at 1 site in Canada.
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 9 inclusion and 5 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: finished, as of the sponsor's last update on 14 Feb 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 Canada. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lymphocyte count (time frame: Within 3 months pre-intervention, monthly during intervention, 1 month post-intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2023.