What side effects are associated with this type of intervention?

Common treatments for Chronic Lymphocytic Leukemia (CLL) include Bruton tyrosine kinase (BTK) inhibitors (e.g., ibrutinib), BCL2 inhibitors (e.g., venetoclax), monoclonal antibodies (e.g., rituximab), purine analogs (e.g., fludarabine), and alkylating agents (e.g., bendamustine). Known side effects of these treatments can include nausea, fatigue, diarrhea, infections, cytopenias (e.g., neutropenia, anemia), cardiovascular issues, and gastrointestinal disturbances. Intermittent fasting, as studied for its metabolic and immunological effects, may also influence these side effects by modulating inflammation and metabolism.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Chronic Lymphocytic Leukemia (CLL), including fludarabine, cyclophosphamide, rituximab, alemtuzumab, venetoclax, and obinutuzumab. These drugs are often used in combination regimens, such as FCR (fludarabine, cyclophosphamide, rituximab) and FCCam (fludarabine, cyclophosphamide, alemtuzumab). Venetoclax combined with obinutuzumab is another approved regimen, particularly beneficial for patients with comorbidities. These treatments aim to target cancer cells, modulate the immune system, and improve patient outcomes, aligning with the goals of metabolic and immunological modulation studied in intermittent fasting trials.

What other types of research exist?

Promising alternatives to intermittent fasting for CLL patients include: 1) Integrative methods involving dietary supplements and lifestyle changes, which have shown potential in maintaining stable CLL. 2) Nonmyeloablative hematopoietic cell transplantation (HCT), which has demonstrated significant survival benefits in advanced CLL cases. 3) Rituximab maintenance therapy, which has been effective in overcoming negative prognostic factors such as obesity. These alternatives focus on both metabolic and immunological modulation, offering potential benefits in CLL management.

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Intermittent Fasting for Chronic Lymphocytic Leukemia

N/A

Waitlist Available

Led By Nicol Macpherson, MD, PhD, FRCPC

Research Sponsored by British Columbia Cancer Agency

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 3 months pre-intervention, monthly during intervention, 1 month post-intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two intermittent fasting methods in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. It aims to see which method patients prefer and which has better effects on cancer cells, metabolism, inflammation, and gut health. Participants will try both methods and their health outcomes will be measured and compared.

Who is the study for?

This trial is for people under 85 with chronic B-cell leukemia or lymphoma, who have certain blood and health status markers. They must have completed a prior fasting study and not be on treatments that conflict with fasting.

What is being tested?

The study compares two intermittent fasting methods (16/8 and 5:2) in their effects on cancer cells, metabolism, inflammation, and gut microbiome in patients who've done the 16/8 method before.

What are the potential side effects?

Intermittent fasting may cause fatigue, hunger, irritability, headaches during fast periods. Long-term effects are still being studied but could include nutrient deficiencies if not managed properly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time frame: within 3 months pre-intervention, monthly during intervention, 1 month post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time frame: within 3 months pre-intervention, monthly during intervention, 1 month post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and time frame: within 3 months pre-intervention, monthly during intervention, 1 month post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in autophagy status

Change in inflammation

Change in lymphocyte count [ Time Frame: Within 3 months pre-intervention, monthly during intervention, 1 month post-intervention ]

+2 more

Secondary study objectives

Change in gut microbiome (optional)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: 5:2 MethodExperimental Treatment1 Intervention

Participants will follow the 5:2 Method (an intermittent fasting regimen) for a 90 day duration. This entails eating ad libitum for five days per week ("normal days") and limiting total calorie intake to 800kcals per day ("fasting days") for the remaining two days per week. The fasting days can be sequential or dispersed throughout the week, based on patient preference.

Group II: 16/8 MethodActive Control1 Intervention

Participants will have already followed the 16/8 Method (an intermittent fasting regimen) for a minimum of six days per week for a 90 day duration. This entailed limiting the eating hours to an 8-hour window, then fasting for the remaining 16 hours per day, with the last time of intake being 8pm.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

5:2 Method (intermittent fasting regimen)

2023

N/A

~10

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Chronic Lymphocytic Leukemia (CLL) include Bruton tyrosine kinase (BTK) inhibitors, BCL2 inhibitors, monoclonal antibodies, purine analogs, and alkylating agents. BTK inhibitors, such as ibrutinib, block the BTK enzyme, which is crucial for B-cell receptor signaling, thereby inhibiting the growth and survival of CLL cells. BCL2 inhibitors, like venetoclax, promote apoptosis in CLL cells by targeting the BCL2 protein that prevents cell death. Monoclonal antibodies, such as rituximab, bind to specific antigens on CLL cells, marking them for destruction by the immune system. Purine analogs and alkylating agents, such as fludarabine and cyclophosphamide, interfere with DNA replication and repair, leading to cell death. These treatments are significant for CLL patients as they target the disease at multiple levels, improving survival rates and quality of life. Additionally, understanding their mechanisms can help in exploring complementary therapies like intermittent fasting, which may modulate metabolic and immunological pathways to enhance treatment efficacy.

Real-World Evidence for Chronic Lymphocytic Leukemia in the Era of Targeted Therapies.Chimeric antigen receptors for the adoptive T cell therapy of hematologic malignancies.