Intermittent Fasting Accompanying Chemotherapy in Gynecological Cancers

NCT03162289 | Unknown

• 1 other identifier: FIT 2
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 8

Brief Summary

The aim of this trial is an evaluation of the effectiveness of intermittent fasting as a supplementary therapy in patients with breast cancer and ovarian cancer in respect to quality of life, reduction of side effects and possible reduction in tumor progression.

Conditions

Breast Cancer; Ovarian Cancer

Keywords

Fasting; Vegan

Outcome Measures

Primary Outcomes (1)

• FACT-G

  Summarized change of FACT-G score

  Date of inclusion (baseline), day -2 and +7 at each chemotherapy (CT) in triweekly cycles/-2 days at each CT in weekly cycles and +7 after the last weekly CT, 4 months after inclusion, 3 weeks after end of CT and 1, 2 and 3 years after inclusion

Secondary Outcomes (2)

• Complete remissions

  From date of randomization until the date of surgery

• Millar Payne classification

  after surgery/histological examination, an average 6 months after intervention start

Other Outcomes (18)

• Trial outcome index score (TOI)

  Date of inclusion (baseline), day -2 and +7 at each chemotherapy (CT) in triweekly cycles/-2 days at each CT in weekly cycles and +7 after the last weekly CT, 4 months after inclusion, 3 weeks after end of CT and 1, 2 and 3 years after inclusion

• Total AC (FACT-B/FACT-O)

  Date of inclusion (baseline), day -2 and +7 at each CT in triweekly cycles/-2 days at each CT in weekly cycles and +7 after the last weekly CT, 4 months after inclusion, 3 weeks after end of CT and 1, 2 and 3 years after inclusion

• FACIT-F

  Date of inclusion (baseline), day -2 and +7 at each CT in triweekly cycles/-2 days at each CT in weekly cycles and +7 after the last weekly CT, 4 months after inclusion, 3 weeks after end of CT and 1, 2 and 3 years after inclusion

Study Arms (2)

Fasting

ACTIVE COMPARATOR

60-72 h-modified fasting (36-48 h before and 24 h after chemotherapy)

Other: Fasting

Vegan

ACTIVE COMPARATOR

60-72 h-vegan diet (36-48 h before and 24 h after chemotherapy)

Other: Vegan

Interventions

Fasting OTHER

Patients follow a modified fasting regime of 60-72 h (36-48 h before and 24 h after CT) with a dietary energy supply of 350-400kcal per day with vegetable juices during the first four cycles of CT. During the rest of the CT cycles they will observe two days of caloric restriction (24 h before and after CT). Between CTs a mainly vegetarian diet will be performed and the patients are encouraged to follow a pattern of time restricted feeding with 14 h fasting over night at least for six days a week. The patients will receive an individual nutrition training by trained nutritionists.

Fasting

Vegan OTHER

Patients follow a 60-72 h vegan diet with sugar restriction (36-48 h before and 24 h after CT) during the first four cycles of CT. During the rest of the CT cycles they will observe two days of vegan and sugar-restricted diet (24 h before and after CT). Between CTs a mainly vegetarian diet will be performed. The patients will receive an individual nutrition training by trained nutritionists.

Vegan

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years
• Cancer is treated conventionally with an adjuvant or neo-adjuvant protocol with at least 4 CT cycles
• The following CTs are considered for breast carcinoma:
• \- (EC, Sparano) 4 x Epirubicin and Cyclophosphamide, followed by 12 cycles Paclitaxel weekly
• \- (AC, Henderson) 4 x Doxorubicin, cyclophosphamide, followed by 4 cycles Docetaxel every three weeks
• If the recruitment rate is not reached, further CT protocols can be accepted.
• CT for patients with ovarian cancer: According to current protocols, at least 4 planned cycles. For the study a maximum of 8 cycles are considered (except therapy with Taxol).

You may not qualify if:

• Reduction in CT dose compared to usual dosage
• Excessive underweight (BMI \<19kg / m2) or actual weight reduction \> 3kg or \> 5kg in the last 1 or 3 months.
• Pre-existing eating disorder (Anorexia nervosa, Bulimia)
• Renal insufficiency (creatinine\> 2mg / dl)
• Severe disease or other disease with a significant reduction in mobility and overall vitality
• Diabetes mellitus
• Lack of email address and Internet access (due to electronic CRF)

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (8)

Albert-Ludwigs-University of Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79085, Germany

Location

Klinikum Ludwigsburg

Ludwigsburg, Baden-Wurttemberg, 71640, Germany

Location

Ernst-von-Bergmann Klinikum, Klinik für Gynäkologie und Geburtshilfe

Potsdam, Brandenburg, 14467, Germany

Location

Brustzentrum Charite Campus Mitte

Berlin, 10117, Germany

Location

Vivantes Brustzentrum

Berlin, 10967, Germany

Location

Charité Virchow Klinikum

Berlin, 13353, Germany

Location

Brustzentrum Krankenhaus Waldfriede

Berlin, 14163, Germany

Location

Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus

Berlin, 14163, Germany

Location

Related Publications (1)

• Koppold-Liebscher D, Kessler CS, Steckhan N, Bahr V, Kempter C, Wischnewsky M, Hubner M, Kunz B, Paul M, Zorn S, Sari S, Jeitler M, Stange R, Michalsen A. Short-term fasting accompanying chemotherapy as a supportive therapy in gynecological cancer: protocol for a multicenter randomized controlled clinical trial. Trials. 2020 Oct 15;21(1):854. doi: 10.1186/s13063-020-04700-9.

  PMID: 33059765 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Ovarian Neoplasms; Fasting

Interventions

Angptl4 protein, mouse; Diet, Vegan

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Diet, Vegetarian; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Andreas Michalsen, Prof. Dr.

  Study Principal Investigator Charite

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 10, 2017
• First Posted: May 22, 2017
• Study Start: May 10, 2017
• Primary Completion: June 10, 2025
• Study Completion: June 10, 2025
• Last Updated: December 13, 2022

Record last verified: 2022-12

Locations

DE (8)