Fasting, Diet, Chemotherapy, ToxicityNCT06015087
Evaluation of the Influence of Short Term Fasting Diet on Chemotherapy-induced Toxicities in Breast Cancer Patients
A study testing fasting diet in people with Fasting, Diet, Chemotherapy, Toxicity, run by University of Thessaly at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fasting, Diet, Chemotherapy, Toxicity
- What is being tested?
- fasting diet
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jul 2022to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- serious cardiovascular disease
- mobility limitations
- being participant in any other study
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Department of Nutrition-Dietetics
Trikala, Thessaly, 42132
Odysseas Androutsos, PhD, 00306944290774, oandroutsos@uth.gr
Niki Kontou, PhD, 00306972668912, niki.kontou@yahoo.gr
About this study
Official title: Fasting Diet and Chemotherapy Toxicity
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.
Read the 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.
- Conditions
- Fasting, Diet, Chemotherapy, Toxicity
- Being tested
- fasting diet
- Keywords
- fasting diet, breast cancer, chemotherapy toxicity, Mediterranean Diet
- Medical subject headings
- Fasting, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fasting dietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Other: fasting diet |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the influence of short term fasting diet on the incidence of treatment-emergent adverse events [safety and tolerability]) caused by chemotherapy
Grade of toxicity will be accessed after each chempotherapy, using the National Cancer Institute Common Terminology Criteria for Adverse Events and eorct. Data will be collected and comparison between the two groups will be performed after each chemotherapy cycle.
Measured: The patients with receive 4-8 cycles of chemotherapy,each cycle is repeated every 21 days. At the end of each cycle and prior next cycle the incidence of treatment - emergent adverse events (safety and tolerability) will be accessed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start1 Jul 2022
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fasting, Diet, Chemotherapy, ToxicityStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Odysseas Androutsos, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015087
- Sponsor's protocol ID
- Fasting diet
- Status last verified
- Aug 2023
- First submitted
- 25 Jul 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fasting Diet and Chemotherapy Toxicity
- ClinicalTrials.gov ID
- NCT06015087
- Acronym / sponsor ID
- Fasting diet
- Conditions
- Fasting, Diet, Chemotherapy, Toxicity
- Keywords
- fasting diet, breast cancer, chemotherapy toxicity, Mediterranean Diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: fasting diet |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fasting dietA 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. | Other | Intervention group |
Primary outcome
Evaluation of the influence of short term fasting diet on the incidence of treatment-emergent adverse events [safety and tolerability]) caused by chemotherapy
Time frame: The patients with receive 4-8 cycles of chemotherapy,each cycle is repeated every 21 days. At the end of each cycle and prior next cycle the incidence of treatment - emergent adverse events (safety and tolerability) will be accessed.
Grade of toxicity will be accessed after each chempotherapy, using the National Cancer Institute Common Terminology Criteria for Adverse Events and eorct. Data will be collected and comparison between the two groups will be performed after each chemotherapy cycle.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Ovarian Cancer, Chemotherapeutic Toxicity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fasting diet in people with Fasting, Diet, Chemotherapy, Toxicity, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the influence of short term fasting diet on the incidence of treatment-emergent adverse events [safety and tolerability]) caused by chemotherapy (time frame: The patients with receive 4-8 cycles of chemotherapy,each cycle is repeated every 21 days. At the end of each cycle and prior next cycle the incidence of treatment - emergent adverse events (safety and tolerability) will be accessed.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.