Clinical trial NCT06645093: Feasibility of Intermittent Fasting During Chemotherapy
Official title: Intermittent Fasting During Curatively Intended Chemotherapy for Malignant Lymphoma - a Randomized Feasibility Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lymphoma
Cancer
Fasting
Keywords: Chemotherapeutic Toxicity
Chemotherapy
Adverse Effect
Short-term fasting
Feasibility studies
Fasting
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
First posted: 2024-10-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Safety and feasibility study,-pilot study
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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


Eligibility criteria: 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

Primary outcomes:
measure: Safety
timeFrame: 1 year
measure: Feasibility
timeFrame: 1 year
measure: Acceptability
timeFrame: 1 year
Secondary outcomes:
measure: Adverse events from chemotherapy
timeFrame: 1 year
measure: Toxicity, including hematological toxicity and standard organ toxicity
timeFrame: 1 year
measure: Health-Related Quality of Life
timeFrame: 1 year
measure: Nutritional impact symptoms
timeFrame: 1 year
measure: Dietary intake
timeFrame: 1 year
measure: Weight loss, body mass index (BMI) and body compositon
timeFrame: 1 year
measure: Unplanned readmissions and hospitalization
timeFrame: 1 year
Other outcomes:
measure: Mechanistic aspects of fasting
timeFrame: 1 year
measure: Fasting and microbiota
timeFrame: 1 year
Locations:
Study officials:
affiliation: Department of Nutrition, University of Oslo
name: Sonja Brunvoll, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nutrition, University of Oslo
name: Inger Ottestad, PhD
role: PRINCIPAL_INVESTIGATOR
References: