NCT01954836

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 7, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

December 13, 2016

Status Verified

December 1, 2016

Enrollment Period

1.4 years

First QC Date

September 29, 2013

Last Update Submit

December 12, 2016

Conditions

NeoplasiaCancerFasting

Keywords

short-term fastingadjuvant chemotherapytoxicityside-effectsovarial carinomabreast cancer

Outcome Measures

Primary Outcomes (1)

  • Quality of life, modified FACT-O

    24 h and 7 days after chemotherapy cycle

Secondary Outcomes (3)

  • Fatigue

    24 h and 7 days after chemotherapy cycle

  • Intensity of adverse effects structured criteria Likert scales

    24 h and 7 days after chemotherapy cycles

  • Laboratory assessments (blood count, liver, renal function)

    24 h and 7 days after chemotherapy cycles

Study Arms (2)

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)

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)

Behavioral: Secondary fasting

Interventions

initial fastingBEHAVIORAL

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

Initial fasting
Secondary fastingBEHAVIORAL

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

Secondary fasting

Eligibility Criteria

Age35 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ovarian cancer or breast cancer
  • scheduled chemotherapy
  • First diagnosis or 1.recurrence
  • mono

You may not qualify if:

  • cachexia (BMI \< 21kg/m2)
  • eating disorder
  • renal failure (Crea \>2mg/dl)
  • enterostoma
  • short bowel syndrome
  • not assigned to other studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Charite University

Berlin, State of Berlin, 14109, Germany

Location

Charite University

Berlin, State of Berlin, 14169, Germany

Location

Related Publications (1)

  • 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.

    PMID: 29699509DERIVED

MeSH Terms

Conditions

NeoplasmsFastingIntermittent FastingBreast Neoplasms

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • andreas A Michalsen, M.D.

    Charite University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.Dr.med Andreas Michalsen

Study Record Dates

First Submitted

September 29, 2013

First Posted

October 7, 2013

Study Start

October 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

December 13, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)