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Enrolling by Invitation

NCT Number: NCT06645093

Feasibility of Intermittent Fasting During Chemotherapy

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition, University of Oslo

Oslo, 0372, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fasting

Other

Fasting implies 0 kilojoule. Water ad libitum is permitted.

Primary outcomes

  1. Safety, measured as 1) number of adverse events

    Time frame: 1 year

    To test whether fasting is safe. 1) Explored by investigating adverse events from intermittent water-only fasting

  2. Safety, measured as 2) changes in body weight

    Time frame: 1 year

    To test whether fasting is safe. 2) by investigating changes in body weight throughout the treatment comparing the intervention and control groups.

  3. Feasibility,- measured by 1) recruitment (attrition rate)

    Time frame: 1 year

    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.

  4. Feasibility,- measured as 2) compliance

    Time frame: 1 year

    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.

  5. Acceptability,- patient burden, acceptance and experience

    Time frame: 1 year

    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

Secondary outcomes

  1. Adverse events from chemotherapy

    Time frame: 1 year

    Adverse events including number of infections, graded according to Common Terminology Criteria for Adverse Events

  2. Toxicity, including hematological toxicity and standard organ toxicity

    Time frame: 1 year

    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)

  3. Health-Related Quality of Life

    Time frame: 1 year

    By using EORTC QLQ-C30 questionnaire

  4. Nutritional impact symptoms

    Time frame: 1 year

    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

  5. Dietary intake

    Time frame: 1 year

    Dietary intake 24 hours before and 24 hours after chemotherapy and the usual intake between chemotherapy cycles using food diary.

  6. Weight loss, body mass index (BMI) and body compositon

    Time frame: 1 year

    Bioelectrical impedance (BIA) will be used to collect data to explore changes in body weight, BMI and body composition.

  7. Unplanned readmissions and hospitalization

    Time frame: 1 year

    In terms of numbers of readmissions, unplanned out- or inpatient visits, and days in the hospital

Other outcomes

  1. Mechanistic aspects of fasting

    Time frame: 1 year

    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).

  2. Fasting and microbiota

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

  • Akershus University Hospital Trust
  • Oslo University Hospital
  • St. Olavs Hospital

Registry information

Official study title

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

Acronym: FasteStudien

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 16, 2024
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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