LymphomaFasteStudienNCT06645093
Feasibility of Intermittent Fasting During Chemotherapy
A study testing Fasting in people with Lymphoma and Cancer, run by University of Oslo at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- Fasting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- 31 Oct 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Department of Nutrition, University of Oslo
Oslo, Oslo, 0372
Sonja H. Brunvoll, PhD, +4792087911, s.h.brunvoll@medisin.uio.no
Inger Ottestad, PhD, +4799735017, i.o.ottestad@medisin.uio.no
About this study
Official title: 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:
Read more
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
- Being tested
- Fasting
- Keywords
- Chemotherapeutic Toxicity, Chemotherapy, Adverse Effect, Short-term fasting, Feasibility studies, Fasting
- Medical subject headings
- Lymphoma, Neoplasms, Fasting, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FastingOther
Fasting implies 0 kilojoule. Water ad libitum is permitted.
| Study group | Role | What they receive |
|---|---|---|
| Fasting group | Experimental | This group will fast 24 hours before and 24 hours after chemotherapy for all treatment cycles (4-6 cycles). Receives: Other: Fasting |
| Control group | No intervention | This group will receive standard treatment, which include no fasting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 1 year
Secondary outcomes (7)
Adverse events from chemotherapy
Adverse events including number of infections, graded according to Common Terminology Criteria for Adverse Events
Measured: 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)
Measured: 1 year
Health-Related Quality of Life
By using EORTC QLQ-C30 questionnaire
Measured: 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
Measured: 1 year
Dietary intake
Dietary intake 24 hours before and 24 hours after chemotherapy and the usual intake between chemotherapy cycles using food diary.
Measured: 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.
Measured: 1 year
Unplanned readmissions and hospitalization
In terms of numbers of readmissions, unplanned out- or inpatient visits, and days in the hospital
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start31 Oct 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Safety and feasibility study,-pilot study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, St. Olavs Hospital, Akershus University Hospital Trust
- Responsible party
- Principal investigator, Sonja H. Brunvoll, PhD, University of Oslo
- Investigators
- Sonja Brunvoll, PhD, Principal investigator, Department of Nutrition, University of OsloInger Ottestad, PhD, Principal investigator, Department of Nutrition, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645093
- Sponsor's protocol ID
- FasteStudien
- Acronym
- FasteStudien
- Status last verified
- Aug 2026
- First submitted
- 14 Oct 2024
- Last updated
- 20 Aug 2026
- 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 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Fasting During Curatively Intended Chemotherapy for Malignant Lymphoma - a Randomized Feasibility Trial
- ClinicalTrials.gov ID
- NCT06645093
- Acronym / sponsor ID
- FasteStudien / FasteStudien
- Keywords
- Chemotherapeutic Toxicity, Chemotherapy, Adverse Effect, Short-term fasting, Feasibility studies, Fasting
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Oslo University Hospital, St. Olavs Hospital, Akershus University Hospital Trust
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Oct 2024 (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 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Safety and feasibility study,-pilot study
| Arm | Type | Receives |
|---|---|---|
| Fasting group | Experimental | Other: FastingThis group will fast 24 hours before and 24 hours after chemotherapy for all treatment cycles (4-6 cycles). |
| Control group | No intervention | –This group will receive standard treatment, which include no fasting. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| FastingFasting implies 0 kilojoule. Water ad libitum is permitted. | Other | Fasting group |
Primary outcome
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
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.
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.
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.
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
7 secondary outcomes
Adverse events from chemotherapy
Time frame: 1 year
Toxicity, including hematological toxicity and standard organ toxicity
Time frame: 1 year
Health-Related Quality of Life
Time frame: 1 year
Nutritional impact symptoms
Time frame: 1 year
Dietary intake
Time frame: 1 year
Weight loss, body mass index (BMI) and body compositon
Time frame: 1 year
Unplanned readmissions and hospitalization
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- 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.
Sonja Brunvoll, PhD principal investigator
Department of Nutrition, University of Oslo
Inger Ottestad, PhD principal investigator
Department of Nutrition, University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting in people with Lymphoma and Cancer, run by University of Oslo at 1 site in Norway.
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 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: looking for participants now, as of the sponsor's last update on 20 Aug 2026. 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 Norway. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sonja Brunvoll, PhD (+4792087911, s.h.brunvoll@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety, measured as 1) number of adverse events (time frame: 1 year). The study lists 5 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 20 Aug 2026.