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NCT00757094 Clinical Trial

Safety and Feasibility of Fasting While Receiving Chemotherapy

Cancer Clinical Trial

Official title:
Safety and Feasibility of Fasting While Receiving Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00757094
Other study ID # KFMC IRB-08-040
Secondary ID
Status Completed
Phase N/A
First received September 19, 2008
Last updated February 24, 2010
Start date September 2008
Est. completion date March 2009

Study information
Verified date February 2010
Source King Fahad Medical City
Contact n/a
Is FDA regulated No
Health authority Saudi Arabia: Ministry of Health
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date March 2009
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age > 18 years

- Established diagnosis of cancer

- Signed informed consent

- Adequate CBC and chemistry to receive chemotherapy

Exclusion Criteria:

- Pregnancy

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Saudi Arabia King Fahad Medical City Riyadh

Sponsors (1)
Lead Sponsor Collaborator
King Fahad Medical City

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Safety of fasting while receiving chemotherapy two months Yes
Secondary Effect of fasting on chemotherapy side effects two months No
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