Safety and Feasibility of Fasting While Receiving Chemotherapy
February 24, 2010 updated by: King Fahad Medical City
Fasting (refraining from eating and drinking) during the day is safe while receiving chemotherapy.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
12
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Riyadh, Saudi Arabia, 11525
- King Fahad Medical City
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Fasting patients who are schedulled to receive chemotherapy during the month of Ramadan
Description
Inclusion Criteria:
- Age > 18 years
- Established diagnosis of cancer
- Signed informed consent
- Adequate CBC and chemistry to receive chemotherapy
Exclusion Criteria:
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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I
Patients planning to observe fasting while receiving chemotherapy during the month of Ramadan
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Safety of fasting while receiving chemotherapy
Time Frame: two months
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two months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Effect of fasting on chemotherapy side effects
Time Frame: two months
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two months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ali SM Al-Shanqeeti, MD, King Fahad Medical City
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Raffaghello L, Lee C, Safdie FM, Wei M, Madia F, Bianchi G, Longo VD. Starvation-dependent differential stress resistance protects normal but not cancer cells against high-dose chemotherapy. Proc Natl Acad Sci U S A. 2008 Jun 17;105(24):8215-20. doi: 10.1073/pnas.0708100105. Epub 2008 Mar 31.
- Weindruch R, Walford RL. Dietary restriction in mice beginning at 1 year of age: effect on life-span and spontaneous cancer incidence. Science. 1982 Mar 12;215(4538):1415-8. doi: 10.1126/science.7063854.
- Ross MH, Bras G. Lasting influence of early caloric restriction on prevalence of neoplasms in the rat. J Natl Cancer Inst. 1971 Nov;47(5):1095-113. No abstract available.
- Klurfeld DM, Welch CB, Lloyd LM, Kritchevsky D. Inhibition of DMBA-induced mammary tumorigenesis by caloric restriction in rats fed high-fat diets. Int J Cancer. 1989 May 15;43(5):922-5. doi: 10.1002/ijc.2910430532.
- Dirx MJ, Zeegers MP, Dagnelie PC, van den Bogaard T, van den Brandt PA. Energy restriction and the risk of spontaneous mammary tumors in mice: a meta-analysis. Int J Cancer. 2003 Sep 20;106(5):766-70. doi: 10.1002/ijc.11277.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
September 19, 2008
First Submitted That Met QC Criteria
September 19, 2008
First Posted (Estimate)
September 22, 2008
Study Record Updates
Last Update Posted (Estimate)
February 25, 2010
Last Update Submitted That Met QC Criteria
February 24, 2010
Last Verified
February 1, 2010
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- KFMC IRB-08-040
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.