Feasibility of Intermittent Fasting During Chemotherapy (FasteStudien)

Intermittent Fasting During Curatively Intended Chemotherapy for Malignant Lymphoma - a Randomized Feasibility Trial

The goal of this randomized controlled parallel group trial is to examine if fasting before and after chemotherapy is safe, feasible and acceptable. The study population will include patients with either Hodgkin lymphoma or Diffuse Large B Cell Lymphoma.

The main questions aimed to answer are:

Whether fasting during chemotherapy is safe for patients, whether it is feasible to implement in a clinical setting, and whether patients find it acceptable.

We also want to examine a number of patient-reported outcome measures regarding health status and quality of life, such as dietary intake and adverse events from chemotherapy.

Researchers will compare fasting to standard treatment.

Participants will:

• Fast 24 hours before and 24 hours after chemotherapy in addition to standard treatment or receive only standard treatment
• Keep a diary of their dietary intake 24 hours before and 24 hours after chemotherapy
• Keep a diary of their dietary intake for three consecutive days between chemotherapy cycles
• Answer questionnaires/questions in relation to side effects from fasting, side effects/adverse events of chemotherapy, quality of life
• Take bioimpedance analysis (including body mass index and body composition)
• Take blood- and feces samples

Study Overview

• Status: Enrolling by invitation
• Conditions: Lymphoma; Cancer; Fasting
• Intervention / Treatment: Other: Fasting

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo County
    • Oslo, Oslo County, Norway, 0372
      • Department of Nutrition, University of Oslo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients diagnosed with diffuse large B-cell lymphoma planned to receive R-CHOP (rituximab, vincristine, doxorubicin, cyclophosphamide, and prednisolone) and Hodgkin lymphoma receiving ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine)
• Age ≥ 18 years
• ECOG status 0-2
• Normal weight and overweight (BMI ≥ 18,5 kg/m^2)

Exclusion Criteria:

• Receiving concurrent radiation therapy and/or treatment
• Other concomitant disease that may make intermittent fasting complicated such as diabetes mellitus
• ECOG status: > 3
• BMI < 18,5 kg/m2
• Age > 80 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fasting group; This group will fast 24 hours before and 24 hours after chemotherapy for all treatment cycles (4-6 cycles).	Other: Fasting; Fasting implies 0 kilojoule. Water ad libitum is permitted.
No Intervention: Control group; This group will receive standard treatment, which include no fasting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety, measured as 1) number of adverse events	To test whether fasting is safe. 1) Explored by investigating adverse events from intermittent water-only fasting	1 year
Safety, measured as 2) changes in body weight	To test whether fasting is safe. 2) by investigating changes in body weight throughout the treatment comparing the intervention and control groups.	1 year
Feasibility,- measured by 1) recruitment (attrition rate)	Whether fasting is feasible. Explored in order to determine whether a larger trial can be successfully conducted in a similar setting with lymphoma patients fasting during cancer treatment.	1 year
Feasibility,- measured as 2) compliance	Whether fasting is feasible. Explored in order to determine whether a larger trial can be successfully conducted in a similar setting with lymphoma patients fasting during cancer treatment.	1 year
Acceptability,- patient burden, acceptance and experience	Whether fasting is acceptable. Explored from a perspective of the participant, as the degree to which patients find the trial, its procedures, and its interventions agreeable, suitable, and satisfactory during chemotherapy treatment	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events from chemotherapy	Adverse events including number of infections, graded according to Common Terminology Criteria for Adverse Events	1 year
Toxicity, including hematological toxicity and standard organ toxicity	Evaluation of toxicity, including hematological toxicity and other relevant organ toxicities with blood test and using computer tomography (CT) or fluoro-deoxy-glucose positron emission tomography computer tomography (FDG-PET-CT)	1 year
Health-Related Quality of Life	By using EORTC QLQ-C30 questionnaire	1 year
Nutritional impact symptoms	The linguistic and content validation of the translated and culturally adapted Patient Generated Subjective Global Assessment (PG-SGA) will be utilized for gathering data on nutritional impact symptoms	1 year
Dietary intake	Dietary intake 24 hours before and 24 hours after chemotherapy and the usual intake between chemotherapy cycles using food diary.	1 year
Weight loss, body mass index (BMI) and body compositon	Bioelectrical impedance (BIA) will be used to collect data to explore changes in body weight, BMI and body composition.	1 year
Unplanned readmissions and hospitalization	In terms of numbers of readmissions, unplanned out- or inpatient visits, and days in the hospital	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mechanistic aspects of fasting	To better understand nutrition and metabolism related to fasting and cancer, we want to examine various biomarkers related to glucose, amino acid and fat metabolism, and inflammation, such as e.g. glucose, insulin, amino acids, triglycerides, C-reactive protein (CRP).	1 year
Fasting and microbiota	We will analyze the gut microbiota to explore the effect of fasting on the gut microbiota. We will collect feces samples at start and end of treatment to characterize the microbiota using high throughput sequencing.	1 year

Collaborators and Investigators

• Sponsor: University of Oslo
• Collaborators: Oslo University Hospital; St. Olavs Hospital; Akershus University Hospital Trust
• Investigators: Principal Investigator: Sonja Brunvoll, PhD, Department of Nutrition, University of Oslo; Principal Investigator: Inger Ottestad, PhD, Department of Nutrition, University of Oslo

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 14, 2024
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Chemotherapy; Fasting; Feasibility studies; Adverse Effect; Chemotherapeutic Toxicity; Short-term fasting
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Behavior; Hemic and Lymphatic Diseases; Feeding Behavior; Neoplasms; Lymphoma; Fasting; Intermittent Fasting; Angptl4 protein, mouse
• Other Study ID Numbers: FasteStudien

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No