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Evaluation of the Influence of Short Term Fasting Diet on Chemotherapy-induced Toxicities in Breast Cancer Patients

Sponsor
University of Thessaly (Other)
Overall Status
Recruiting
CT.gov ID
NCT06015087
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: fasting diet
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Fasting Diet and Chemotherapy Toxicity
Actual Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

Other: 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.
No Intervention: Control group

Outcome Measures

Primary Outcome Measures

  1. Evaluation of the influence of short term fasting diet on the incidence of treatment-emergent adverse events [safety and tolerability]) caused by chemotherapy [Participants will be followed from date of randomization until one month after the last chemotherapy.]

    Grade of toxicity will be accessed after each chempotherapy, using the National Cancer Institute Common Terminology Criteria for Adverse Events and eorct. Comparison between the two groups will be performed after each chemotherapy cycle.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Nutrition-Dietetics Tríkala Thessaly Greece 42132

Sponsors and Collaborators

  • University of Thessaly

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Odysseas Androutsos, Associate Professor of Clinical Nutrition and Dietetics, University of Thessaly
ClinicalTrials.gov Identifier:
NCT06015087
Other Study ID Numbers:
  • Fasting diet
First Posted:
Aug 29, 2023
Last Update Posted:
Aug 29, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Odysseas Androutsos, Associate Professor of Clinical Nutrition and Dietetics, University of Thessaly
fasting diet, breast cancer, chemotherapy toxicity, Mediterranean Diet

Study Results

No Results Posted as of Aug 29, 2023