FastingNCT00757094
Safety and Feasibility of Fasting While Receiving Chemotherapy
An observational study of Fasting and Chemotherapy, run by King Fahad Medical City at 1 site in Saudi Arabia.
Trial summary
Fasting (refraining from eating and drinking) during the day is safe while receiving chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fasting, Chemotherapy, Cancer
- How many people
- 12 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Sep 2008to Mar 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Fasting patients who are schedulled to receive chemotherapy during the month of Ramadan
Who may be able to join
- Age > 18 years
- Established diagnosis of cancer
- Signed informed consent
- Adequate CBC and chemistry to receive chemotherapy
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Fasting (refraining from eating and drinking) during the day is safe while receiving chemotherapy.
- Conditions
- Fasting, Chemotherapy, Cancer
- Keywords
- Fasting, Chemotherapy, Cancer
- Medical subject headings
- Fasting, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| I | Patients planning to observe fasting while receiving chemotherapy during the month of Ramadan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of fasting while receiving chemotherapy
Measured: two months
Secondary outcomes (1)
Effect of fasting on chemotherapy side effects
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for FastingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Fahad Medical City
- Sponsor type
- Other government
- Investigators
- Ali SM Al-Shanqeeti, MD, Principal investigator, King Fahad Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00757094
- Sponsor's protocol ID
- KFMC IRB-08-040
- Status last verified
- Feb 2010
- First submitted
- 19 Sep 2008
- Last updated
- 25 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 18378900Weindruch 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.
PubMed 7063854Ross 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.
PubMed 4330798Klurfeld 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.
PubMed 2497075Dirx 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.
PubMed 12866038
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Fasting While Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT00757094
- Acronym / sponsor ID
- KFMC IRB-08-040
- Conditions
- Fasting, Chemotherapy, Cancer
- Keywords
- Fasting, Chemotherapy, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- King Fahad Medical CityOther government
- Study start
- Sep 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 22 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fasting (refraining from eating and drinking) during the day is safe while receiving chemotherapy.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | – | –Patients planning to observe fasting while receiving chemotherapy during the month of Ramadan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Fasting patients who are schedulled to receive chemotherapy during the month of Ramadan
Key inclusion criteria (4 listed)
- Age > 18 years
- Established diagnosis of cancer
- Signed informed consent
- Adequate CBC and chemistry to receive chemotherapy
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety of fasting while receiving chemotherapy
Time frame: two months
1 secondary outcome
Effect of fasting on chemotherapy side effects
Time frame: two months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2010.
- Background: PubMed 18378900Raffaghello 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.
- Background: PubMed 7063854Weindruch 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.
- Background: PubMed 4330798Ross 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.
- Background: PubMed 2497075Klurfeld 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.
- Background: PubMed 12866038Dirx 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali SM Al-Shanqeeti, MD principal investigator
King Fahad Medical City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fasting and Chemotherapy, run by King Fahad Medical City at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of fasting while receiving chemotherapy (time frame: two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00757094, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2010.