Short-Term Fasting During Chemotherapy in Patients With Gynecological Cancer- a Randomized Controlled Cross-over Trial
Condition: Neoplasia; Cancer; Fasting
MeSH terms: Neoplasms
Study type: Interventional

Summary: 
      Hypothesis: Fasting before (48h) and one day after chemotherapy may protect normal cells from
      the adverse effects of chemotherapy. Design: Within a randomized controlled pilot trial 30
      female patients with gynecological cancer (ovarian and breast cancer)and 4-6 scheduled
      chemotherapies will be randomized to fast 60-72 hours during the first half of chemotherapies
      or during the second half of chemotherapies and to proceed normocaloric food intake during
      the other cycles.Sequence of fasting and normocaloric food intake will be randomized.
      Assessments of adverse effects, quality of life and laboratory values take place 24 and 7
      days after each chemotherapy. Statistical analyses compare summarized differences of fasted
      and non-fasted chemotherapy cycles.
    

Detailed description: 
      Evidence from experimental animals provides strong support for the concept that caloric
      restriction (CR) increases resistance to multiple forms of stress. CR decreases plasma levels
      of growth factors, e.g. insulin-like growth factor-I (IGF-I), thereby diverting energy from
      growth to maintenance. Accordingly, the currently available information suggests that
      short-term fasting protects normal cells against the perils of (high dose) chemotherapy. In
      contrast, cancer cells are not (or less) protected as a result of their self-sufficiency in
      growth signals. This phenomenon is termed Differential Stress Resistance (DSR). DSR may
      reduce the severity of adverse effects caused by chemotherapy, without interfering with its
      anti-tumoral effects. A first case series of 10 cancer patients, suggested that short-term
      fasting may also protect against the side effects of chemotherapy in humans. This study aims
      to further evaluate the impact of short-term fasting on tolerance to chemotherapy in
      humans.Within a randomized controlled pilot trial 30 female patients with gynecological
      cancer disease (ovarian and breast cancer)in all stages and 4-6 scheduled chemotherapies will
      be randomized to fast 60-72 hours during half of chemotherapies and to have normocaloric food
      intake during the other chemotherapies. Fasting is defined as caloric restriction to below
      400kcal energy intake/day with free intake of water and tea. Sequences of fasting and
      normocaloric food intake will be randomized. Assessments of adverse effects, quality of life,
      fatigue and laboratory values will take place 24 and 7 days after each chemotherapy.
      Statistical analyses will compare the summarized differences of fasted and non-fasted
      chemotherapy cycles, that means a total of max. 60-90 chemotherapies with accompanying
      fasting will be compared to 60-90 non-fasted chemotherapies.
    

Intervention name(s): initial fasting; Secondary fasting
Intervention type(s): Behavioral; Behavioral
Intervention description(s): modified fasting with daily caloric intake of <400kcal by juices starting 36 to 48 h before begin of chemotherapy and lasting to 24 h after end of chemotherapy applied in the first half of scheduled 4 or 6 chemotherapy cycles; modified fasting with daily caloric intake of <400kcal by juices starting 36 to 48 h before begin of chemotherapy and lasting to 24 h after end of chemotherapy applied in the second half of scheduled 4 or 6 chemotherapy cycles
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: short-term fasting; adjuvant chemotherapy; toxicity; side-effects; ovarial carinoma; breast cancer