To hear about similar clinical trials, please enter your email below
Trial Title:
Evaluation of the Influence of Short Term Fasting Diet on Chemotherapy-induced Toxicities in Breast Cancer Patients
NCT ID:
NCT06015087
Condition:
Fasting, Diet, Chemotherapy, Toxicity
Conditions: Keywords:
fasting diet, breast cancer, chemotherapy toxicity, Mediterranean Diet
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
fasting diet
Description:
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.
Arm group label:
Intervention group
Summary:
This is a clinical trial aiming to assess the effect of fasting diet on chemotherapy -
induced toxicities in breast cancer patients. The study will have an intevention group
and a control group. The intervention group will follow a fasting diet of 60 hours (36h
prior chemotherapy and 24h after the end of chemotherary), while the control group will
follow regular (standard) diet. At the meantime of the chemotherapy cycles, the
intervention group will be recommended to follow the Mediterranean diet.
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.
Detailed description:
This is a clinical trial aiming to assess the effect of fasting diet on chemotherapy -
induced toxicities in breast cancer patients. The study will have an intevention group
and a control group. The intervention group will follow a fasting diet for 60 hours (36h
prior chemotherapy and 24h after the end of chemotherapy), while the control group will
follow regular diet. At the meantime of the chemotherapy cycles, the intervention group
will be recommended to follow the Mediterranean diet. The patients will be randomized in
the two groups. A total of 50 patients is required. Biochemical data, anthropometric
measures and grading of toxicity according to National Cancer Institute Common
Terminology Criteria for Adverse Events, nutritional habits, adherence to the
Mediterranean diet (implementation of MedDietScore) will be assessed prior, during and
after the intervention, in both groups. Nutritional counseling will be performed by
Registered Dietitian, and telephone interviews will be used to record adherence to
fasting diet and Mediterranean diet.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- breast cancer patients with first diagnosis of breast cancer
- no distinct metastasis
- patients will receive at least 4 cycles of adjuvant or neo-adjuvant chemotherapy
Exclusion Criteria:
- BMI<19kg/m2
- 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Department of Nutrition-Dietetics
Address:
City:
Tríkala
Zip:
42132
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Odysseas Androutsos, PhD
Phone:
00306944290774
Email:
oandroutsos@uth.gr
Contact backup:
Last name:
Niki Kontou, PhD
Phone:
00306972668912
Email:
niki.kontou@yahoo.gr
Start date:
July 1, 2022
Completion date:
July 2024
Lead sponsor:
Agency:
University of Thessaly
Agency class:
Other
Source:
University of Thessaly
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06015087
