NeoplasiaFITNCT01954836
Short-Term Fasting During Chemotherapy in Patients With Gynecological Cancer- a Randomized Controlled Cross-over Trial
A study testing initial fasting and Secondary fasting in people with Neoplasia and Cancer, run by Charite University, Berlin, Germany at 2 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 70 years, women only
- What is being tested?
- initial fasting and Secondary fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesGermany
- Study dates
- Oct 2013to Mar 2015
- 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 35 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ovarian cancer or breast cancer
- scheduled chemotherapy
- First diagnosis or 1.recurrence
- mono
Who cannot join
- cachexia (BMI < 21kg/m2)
- eating disorder
- renal failure (Crea >2mg/dl)
- enterostoma
- short bowel syndrome
- not assigned to other studies
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Charite University
Berlin, State of Berlin, 14109
Charite University
Berlin, State of Berlin, 14169
About this study
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.
Read the 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.
- Being tested
- initial fasting, Secondary fasting
- Keywords
- short-term fasting, adjuvant chemotherapy, toxicity, side-effects, ovarial carinoma, breast cancer
- Medical subject headings
- Neoplasms, Fasting, Intermittent Fasting, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
initial fastingBehavioural
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
Secondary fastingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Initial fasting | Experimental | Fasting during chemotherapy of the first half of chemotherapy cycles (1 and 2 of four or 1 to 3 of six cycles) Receives: Behavioral: initial fasting |
| Secondary fasting | Active comparator | Fasting during the second half of chemotherapy cycles (3 and 4 of four cycles or 4 to 6 of six cycles) Receives: Behavioral: Secondary fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life, modified FACT-O
Measured: 24 h and 7 days after chemotherapy cycle
Secondary outcomes (3)
Fatigue
Measured: 24 h and 7 days after chemotherapy cycle
Intensity of adverse effects structured criteria Likert scales
Measured: 24 h and 7 days after chemotherapy cycles
Laboratory assessments (blood count, liver, renal function)
Measured: 24 h and 7 days after chemotherapy cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasiaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Michalsen, Charite University, Berlin, Germany
- Investigators
- andreas A Michalsen, M.D., Principal investigator, Charite University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954836
- Sponsor's protocol ID
- FIT08/2013
- Acronym
- FIT
- Status last verified
- Dec 2016
- First submitted
- 29 Sep 2013
- Last updated
- 13 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bauersfeld SP, Kessler CS, Wischnewsky M, Jaensch A, Steckhan N, Stange R, Kunz B, Bruckner B, Sehouli J, Michalsen A. The effects of short-term fasting on quality of life and tolerance to chemotherapy in patients with breast and ovarian cancer: a randomized cross-over pilot study. BMC Cancer. 2018 Apr 27;18(1):476. doi: 10.1186/s12885-018-4353-2.
PubMed 29699509
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Fasting During Chemotherapy in Patients With Gynecological Cancer- a Randomized Controlled Cross-over Trial
- ClinicalTrials.gov ID
- NCT01954836
- Acronym / sponsor ID
- FIT / FIT08/2013
- Keywords
- short-term fasting, adjuvant chemotherapy, toxicity, side-effects, ovarial carinoma, breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 7 Oct 2013 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Initial fasting | Experimental | Behavioral: initial fastingFasting during chemotherapy of the first half of chemotherapy cycles (1 and 2 of four or 1 to 3 of six cycles) |
| Secondary fasting | Active comparator | Behavioral: Secondary fastingFasting during the second half of chemotherapy cycles (3 and 4 of four cycles or 4 to 6 of six cycles) |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ovarian cancer or breast cancer
- scheduled chemotherapy
- First diagnosis or 1.recurrence
- mono
Key exclusion criteria (6 listed)
- cachexia (BMI < 21kg/m2)
- eating disorder
- renal failure (Crea >2mg/dl)
- enterostoma
- short bowel syndrome
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 |
|---|---|---|
| initial fastingmodified 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 | Behavioural | Initial fasting |
| Secondary fastingmodified 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 | Behavioural | Secondary fasting |
Primary outcome
Quality of life, modified FACT-O
Time frame: 24 h and 7 days after chemotherapy cycle
3 secondary outcomes
Fatigue
Time frame: 24 h and 7 days after chemotherapy cycle
Intensity of adverse effects structured criteria Likert scales
Time frame: 24 h and 7 days after chemotherapy cycles
Laboratory assessments (blood count, liver, renal function)
Time frame: 24 h and 7 days after chemotherapy cycles
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2016.
- Derived from this study: PubMed 29699509Bauersfeld SP, Kessler CS, Wischnewsky M, Jaensch A, Steckhan N, Stange R, Kunz B, Bruckner B, Sehouli J, Michalsen A. The effects of short-term fasting on quality of life and tolerance to chemotherapy in patients with breast and ovarian cancer: a randomized cross-over pilot study. BMC Cancer. 2018 Apr 27;18(1):476. doi: 10.1186/s12885-018-4353-2.
- Individual participant dataSharing planned: No
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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.
andreas A Michalsen, M.D. principal investigator
Charite University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing initial fasting and Secondary fasting in people with Neoplasia and Cancer, run by Charite University, Berlin, Germany at 2 sites in Germany.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 13 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life, modified FACT-O (time frame: 24 h and 7 days after chemotherapy cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01954836, which also lists 1 linked publication.
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 13 Dec 2016.