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Safety and Feasibility of Fasting While Receiving Chemotherapy
This study is currently recruiting participants.
Verified by King Fahad Medical City, September 2008
First Received: September 19, 2008   No Changes Posted
Sponsored by: King Fahad Medical City
Information provided by: King Fahad Medical City
ClinicalTrials.gov Identifier: NCT00757094
  Purpose

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


Condition
Fasting
Chemotherapy
Cancer

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Crossover, Prospective
Official Title: Safety and Feasibility of Fasting While Receiving Chemotherapy

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 ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 20
Study Start Date: September 2008
Estimated Study Completion Date: November 2008
Estimated Primary Completion Date: November 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

Contacts
Contact: Ali S.M. Al-Shanqeeti, MD 96612889999 ext 1998 ashanqeeti@gmail.com
Contact: Sayed D. Zaidi, MD 96612889999 ext 7900 szazaidi@hotmail.com

Locations
Saudi Arabia
King Fahad Medical City Recruiting
Riyadh, Saudi Arabia, 11525
Contact: Ali Al-Shanqeeti     96612889999 ext 1998     ashanqeeti@gmail.com    
Principal Investigator: Ali S.M. Al-Shanqeeti, MD            
Sponsors and Collaborators
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: King Fahad Medical City ( Ali Al-Shanqeeti )
Study ID Numbers: KFMC IRB-08-040
Study First Received: September 19, 2008
Last Updated: September 19, 2008
ClinicalTrials.gov Identifier: NCT00757094     History of Changes
Health Authority: Saudi Arabia: Ministry of Health

Keywords provided by King Fahad Medical City:
Fasting
Chemotherapy
Cancer

ClinicalTrials.gov processed this record on May 07, 2009



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