Safety and Feasibility of Fasting While Receiving Chemotherapy

This study has been completed.

Sponsor:

Information provided by:

King Fahad Medical City

ClinicalTrials.gov Identifier:

NCT00757094

First received: September 19, 2008

Last updated: February 24, 2010

Last verified: February 2010

History of Changes

Purpose

Fasting (refraining from eating and drinking) during the day is safe while receiving chemotherapy.

Condition
Fasting Chemotherapy Cancer

Study Type:	Observational
Study Design:	Observational Model: Case-Crossover Time Perspective: Prospective
Official Title:	Safety and Feasibility of Fasting While Receiving Chemotherapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by King Fahad Medical City:

Primary Outcome Measures:

Safety of fasting while receiving chemotherapy [ Time Frame: two months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Effect of fasting on chemotherapy side effects [ Time Frame: two months ] [ Designated as safety issue: No ]

Enrollment:	12
Study Start Date:	September 2008
Study Completion Date:	March 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
I Patients planning to observe fasting while receiving chemotherapy during the month of Ramadan

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Fasting patients who are schedulled to receive chemotherapy during the month of Ramadan

Criteria

Inclusion Criteria:

Age > 18 years
Established diagnosis of cancer
Signed informed consent
Adequate CBC and chemistry to receive chemotherapy

Exclusion Criteria:

Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757094

Locations

Saudi Arabia
King Fahad Medical City
Riyadh, Saudi Arabia, 11525

Sponsors and Collaborators

King Fahad Medical City

Investigators

Principal Investigator:

Ali SM Al-Shanqeeti, MD

King Fahad Medical City

More Information

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. 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.

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.

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.

Responsible Party:	Ali Al-Shanqeeti, King Fahad Medical City
ClinicalTrials.gov Identifier:	NCT00757094 History of Changes
Other Study ID Numbers:	KFMC IRB-08-040
Study First Received:	September 19, 2008
Last Updated:	February 24, 2010
Health Authority:	Saudi Arabia: Ministry of Health

Keywords provided by King Fahad Medical City:

Fasting
Chemotherapy
Cancer

ClinicalTrials.gov processed this record on May 19, 2013

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