Feasibility of Intermittent Fasting During Chemotherapy (Fastestudien)

University of Oslo

Status: Invitation-only

Conditions: Lymphoma; Cancer; Fasting

Treatments: Other: Fasting

Study type: Interventional

Funder types: Other

Identifiers

NCT06645093

FasteStudien

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Fasting group

Experimental group

Description:

This group will fast 24 hours before and 24 hours after chemotherapy for all treatment cycles (4-6 cycles).

Treatment:

Other: Fasting

Control group

No Intervention group

Description:

This group will receive standard treatment, which include no fasting.