Evaluation of the Influence of Short Term Fasting Diet on Chemotherapy-induced Toxicities in Breast Cancer Patients
NCT ID: NCT06015087
Last Updated: 2023-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2022-07-01
2024-07-31
Brief Summary
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The main questions this study is aiming to answer is whether short term fasting diet influences chemotherary - induced toxicities and if it is easy to be implemented.
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Detailed Description
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The main questions this study is aiming to answer is whether short term fasting diet influences chemotherary - induced toxicities and if it is easy to be implemented.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Intervention group
fasting diet
A total of 50 patients with breast cancer will be randomly devided in intervention and control group. Intervention group will follow a 60 hours fasting diet (36h prior and 24h after chemotherapy infusion), low in calories, mainly plant based, and the Mediterranean Diet in the meantime between chemotherapy cycles. Control group will receive only standard of care. Nutritional counseling and dietary records will be performed by registered dietitian. Adherence to the Mediterranean Diet will be estimated with MedDietScore. Grade of toxicity will be estimated by using the National Cancer Institute Common Terminology Criteria for Adverse Events. All participants will be encourange to continue usual physical activity.
Control group
No interventions assigned to this group
Interventions
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fasting diet
A total of 50 patients with breast cancer will be randomly devided in intervention and control group. Intervention group will follow a 60 hours fasting diet (36h prior and 24h after chemotherapy infusion), low in calories, mainly plant based, and the Mediterranean Diet in the meantime between chemotherapy cycles. Control group will receive only standard of care. Nutritional counseling and dietary records will be performed by registered dietitian. Adherence to the Mediterranean Diet will be estimated with MedDietScore. Grade of toxicity will be estimated by using the National Cancer Institute Common Terminology Criteria for Adverse Events. All participants will be encourange to continue usual physical activity.
Eligibility Criteria
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Inclusion Criteria
* no distinct metastasis
* patients will receive at least 4 cycles of adjuvant or neo-adjuvant chemotherapy
Exclusion Criteria
* unintentional weight loss of \>3 or \>5 kg the last 3 or 6 months respectively
* medical history of anorexia nervosa, boulimia or any other eating disorders
* renal failure (creatinine \>2mg/dl)
* diabetes mellitus (type I or Insulin dependent type II)
* serious psychiatric disease
* serious cardiovascular disease
* mobility limitations
* being participant in any other study
18 Years
75 Years
FEMALE
Yes
Sponsors
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University of Thessaly
OTHER
Responsible Party
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Odysseas Androutsos
Associate Professor of Clinical Nutrition and Dietetics
Locations
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Department of Nutrition-Dietetics
Trikala, Thessaly, Greece
Countries
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Facility Contacts
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Other Identifiers
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Fasting diet
Identifier Type: -
Identifier Source: org_study_id
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