Trial document



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  DRKS00011610

Trial Description

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Title

Impact of short-term modified fasting and the combination with a fasting supportive diet during chemotherapy on the incidence and severity of chemotherapy-induced toxicities in cancer patients - a randomised controlled cross-over pilot study

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Trial Acronym

MOFAX

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URL of the Trial

https://www.uniklinik-freiburg.de/medizin1/behandlung/zentren-und-sektionen/sektion-ernaehrungsmedizin-und-diaetetik/forschung.html

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

The present pilot study has a randomised controlled cross-over design. Forty adult cancer patients receiving CTX with a minimum of four cycles at a 3- to 4-week interval will be randomised to fast for 96 h during half of CTXs (2-3 cycles) and to consume a normocaloric diet during the other CTXs (2-3 cycles). Fasting will be 4- day modified fasting with a caloric intake of 400-600 kcal/day, representing 25% of each patient's daily requirement. In addition, half of the patients will be randomised to eat a six-day normocaloric ketogenic diet prior each short-term modified fasting period. The ketogenic diet - a very low carbohydrate and high-fat diet - is known to have a hunger-suppression effect. We aim to investigate for the first time whether a ketogenic diet as a fasting supportive diet reduces the fasting-related discomfort during the first days (eg, hunger) and increases the compliance of our fasting regimen. Assessments of CTX-induced toxicities, fasting-related discomfort, quality of life, fatigue, laboratory values, and compliance will take place on day 0 of each CTX cycle.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00011610
  •   2017/01/30
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  •   yes
  •   Approved
  •   313/16, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   cancer
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Interventions/Observational Groups

  •   F = 4-day fasting period during 2 to 3 cycles of chemotherapy followed by NC (normal diet period, normocaloric) during the next 2 to 3 cycles of chemotherapy
  •   FAD+F = 10-day dietary intervention period including 6-day FSD (fasting supportive diat) + 4-day fasting followed by NC (normal diet period, normocaloric) during the next 2 to 3 cycles of chemotherapy
  •   NC (normal diet period, normocaloric) during the 2 to 3 cycles of chemotherapy followed by F = 4-day fasting period during 2 to 3 cycles of chemotherapy
  •   NC (normal diet period, normocaloric) during the 2 to 3 cycles of chemotherapy followed by
    FAD+F = 10-day dietary intervention period including 6-day FSD (fasting supportive diat) + 4-day fasting
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

Chemotherapy-induced toxicity - the percentage of patients with grade III or higher chemotherapie-induced toxicity graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version (NCI CTCAE) v4.0
On day 0 of each chemotherapy cycle and as follow-up 3 weeks after the 4th or 6th cycle

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Secondary Outcome

nutritional status (body weight, height and SGA questionnaire)

Body composition (fat-free mass, body
cell mass, phase angle) with a mobile
multifrequency device (Nutrigard MS™, Data Input GmbH, Darmstadt, Germany)

quality of life (QLQ–C30 questionnaire v.3.0 combined with the breast cancer module EORTC QLQ-BR23 v1.0)

chemotherapy-induced polyneuropathy (QLQ-CIPN20)

Laboratory values:
Glucose, Growth factor (insulin, insulin-like
growth factor), Thyroid hormone (TSH, FT3, FT4), Blood count
Further Laboratory values:
Liver function (bilirubin, ALT, AST, ALP, GGT)
Renal function (creatinine , urea nitrogen, uric acid)
Electrolytes (sodium, potassium, calcium, magnesium)
(Institute of Clinical Chemistry and Laboratory Medicine at
University Medical Centre Freiburg)

metabolic parameters: Ketone bodies
(urine) Reagent strips for self-testing of urinary acetoacetate (Ketostix®, Bayer AG, Switzerland)
Ketone bodies (blood): Testing device with blood β-ketone test strips (FreeStyle Precision Neo(TM) Blood Glucose and Ketone Monitoring System, Abbott GmbH & Co. KG, Germany) TM

Dietary record:
Dietary intake (energy intake, macro-nutrient composition) analysed by professional software (PRODI® expert, Nutri-Science GmbH, Germany)

All data will be collected on day 0 of each chemotherapy cycle and as follow-up 3 weeks after the 4th or 6th cycle

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/03/01
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Age ≥18 years, adequate renal function (serum creatinine, urea nitrogen and uric acid), adequate liver function (ALT, AST, ALP, GGT), life expectancy >6 months, minimum of four cycles of the same chemotherapy protocol at a 3- to 4-week interval with all chemotherapeutic drugs administrated in 24 h, written informed consent

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Exclusion Criteria

Weight loss >5% of body weight in the last 3 months, body mass index <18.5 kg/m2, history of eating disorders (anorexia nervosa, bulimia nervosa or binge eating disorder), patients receiving parenteral nutrition, pregnant or lactating women, serious other diseases such as recent myocardial infarction or clinical signs of cardiac failure, diabetes mellitus undergoing therapy with insulin or oral agents, history of gout or elevated uric acid level, history of syncope with calorie restriction in the past or other medical comorbidity, which would make fasting potentially dangerous, receiving steroids (except dexamethasone given for nausea prevention) or
Receiving concomitant treatment with insulin-like growth factor (IGF)-receptor blockers or monoclonal antibodies targeting the IGF ligands , currently enrolled in a concomitant clinical trial

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Addresses

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    • Universitätsklinikum Freiburg; Klinik für Innere Medizin I; Sektion Ernährungsmedizin & Diätetik
    • Mr.  Dr.  Paul  Urbain 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg; Klinik für Innere medizin I; Hämatologie, Onkologie und Stammzelltransplantation
    • Mr.  Prof. Dr.  Hartmut  Bertz 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg - Klinik für Innere Medizin ISektion Ernährungsmedizin & Diätetik
    • Ms.  Dr.  Anna  Raynor 
    • Hugstetterstr.55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Kirstins WegVerein zur Förderung der Krebsmedizin
    • Mr.  Gerd  Diehl 
    • Postfach 170164
    • 56536  Neuwied
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/03/19
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.