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Malignant NeoplasmNCT01175837

Short-Term Fasting Before Chemotherapy in Treating Patients With Cancer

A study testing questionnaire administration, preventative dietary intervention and laboratory biomarker analysis in people with Malignant Neoplasm, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This clinical trial studies short-term fasting before chemotherapy in treating patients with cancer. Fasting before chemotherapy may protect normal cells from the side effects of chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Neoplasm
What is being tested?
questionnaire administration, preventative dietary intervention and laboratory biomarker analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
13 Aug 2010to 10 Dec 2018
Phase
Interventional
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

Who may be able to join

  • Histologically confirmed malignancy
  • Scheduled to undergo 4 or more cycles of chemotherapy (with or without past chemotherapy treatment); NOTE: Acceptable chemotherapy regimens are those that have all drugs infused on the first day of the chemotherapy cycle over a period =< 8 hours; EXCEPTION: Continuous 5-FU-containing regimens (such as FOLFOX6 and FOLFIRI) are allowed as both the 5-FU bolus as well as the oxaliplatin and irinotecan administration is completed on day 1 of chemotherapy
  • Life expectancy of >= 168 days (6 months)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Body mass index (BMI) > 21 kg/m^2
  • Weight loss < 5% of body weight in the last 168 days (6 months)
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  • Adequate renal function (serum creatinine < 1.5 X UNL [upper normal limit] or creatinine clearance > 50 ml/min)
  • Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
  • Provide informed consent
  • Ability to complete patient booklet by themselves or with assistance
  • Ability and willingness to undergo >= 24-hour fast prior to chemotherapy
  • Willingness to be treated at Mayo Clinic Rochester and be available for follow-up
  • Patient willing to provide blood samples for correlative research purposes

Who cannot join

  • Any of the following:
  • Pregnant women;
  • Nursing women;
  • Men or women of childbearing potential who are unwilling to employ adequate contraception throughout the study period
  • Diabetes mellitus undergoing therapy with insulin or oral agents
  • History of low serum glucose (hypoglycemia) or insulinoma
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  • History of syncope with calorie restriction in the past or other medical comorbidity, which would make fasting potentially dangerous
  • On daily medication that may not be safely taken without food; NOTE: Any non-essential medications and herbal/vitamin supplements should be held to minimize stomach upset during fasting; vitamin C use is discouraged
  • Active gastric or duodenal peptic ulcer disease
  • History of significant cardiac disease, particularly uncompensated congestive heart failure New York Heart Association (NYHA) grade 2 or more or left ventricular ejection fraction (LVEF) < 40% on any prior assessment; NOTE: Assessment of LVEF prior to therapy is not required in the absence of other clinical indicators of heart disease
  • Recent history (< 6 months) of cerebrovascular accident or transient ischemic attacks
  • History of gout or elevated uric acid level
  • Psychiatric conditions that preclude adherence to study protocol
  • Serious intercurrent infections or nonmalignant medical illnesses that are uncontrolled or whose control may potentially be jeopardized by the complications of fasting
  • Patients receiving parenteral nutrition
  • Receiving steroids (except dexamethasone given for nausea prevention before chemotherapy)
  • Patients receiving taxotere-containing chemotherapy regimens requiring pre-treatment steroid administration
  • Receiving concomitant treatment with insulin-like growth factor (IGF)-receptor blockers or monoclonal antibodies targeting the IGF ligands
  • Any of the following (prior to registration):
  • =< 7 days from the time of a minor surgery;
  • =< 21 days from the time of major surgery;
  • =< 21 days from the time of radiation therapy
  • Currently enrolled in a concomitant clinical trial

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Short-Term Fasting Prior to Systemic Chemotherapy: A Pilot Feasibility Study

This clinical trial studies short-term fasting before chemotherapy in treating patients with cancer. Fasting before chemotherapy may protect normal cells from the side effects of chemotherapy.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Assess the safety and feasibility of short-term fasting prior to administration of chemotherapy.

SECONDARY OBJECTIVES:

  1. Evaluate weight changes in patients who are exposed to short-term fasting prior to chemotherapy.

II. Get a preliminary estimate of the longest feasible fasting period prior to chemotherapy.

III. Evaluate the toxicity profile of systemic chemotherapy treatment in patients who undergo short-term fasting prior to treatment.

IV. Investigate changes in plasma glucose, insulin, Insulin-like growth factor 1 (IGF-1) and IGF-1binding proteins (BP) in patients who undertake short-term fasting.

OUTLINE:

COHORT I: Patients fast 24 hours before day 1 of course 2 of chemotherapy. If fast is well tolerated, patients may escalate fasting by 12 hours for each subsequent course of chemotherapy for up to 3 courses in the absence of unacceptable toxicity.

COHORT II: Patients fast at the longest fasting regimen found to be safe and tolerable in cohort I before day 1 of each course of course of chemotherapy for up to 4 courses in the absence of unacceptable toxicity.

Being tested
questionnaire administration, preventative dietary intervention, laboratory biomarker analysis
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • questionnaire administrationOther

    Ancillary studies: Pre- and post-fasting side effect questionnaires

  • preventative dietary interventionOther

    Also called preventative intervention, dietary

    24, 36, or 48 hour fast prior to chemotherapy

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT01175837
Study groupRoleWhat they receive
Short-term fasting prior to systemic chemotherapyExperimentalCOHORT I: Patients fast 24 hours before day 1 of course 2 of chemotherapy. If fast is well tolerated, patients may escalate fasting by 12 hours for each subsequent course of chemotherapy for up to 3 courses in the absence of unacceptable toxicity. COHORT II: Patients fast at the longest fasting regimen found to be safe and tolerable in cohort I before day 1 of each course of course of chemotherapy for up to 4 courses in the absence of unacceptable toxicity.
Receives: Other: questionnaire administration; Other: preventative dietary intervention; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients hospitalized during fasting period (for reasons that are not attributed to disease or post-operative complications)

    Measured: Up to 48 hours

  2. Number of patients experiencing greater than or equal to grade 3 adverse event related to the fasting period

    Measured: Up to 48 hours

  3. Percentage of patients able to achieve designated fasting regimen (i.e., greater than or equal to 50%)

    Measured: Up to 48 hours

Secondary outcomes (5)

  1. Weight changes in patients who are exposed to short-term fasting prior to chemotherapy

    Descriptive statistics will be applied to summarize weight changes from baseline for each subsequent course.

    Measured: Baseline and 4 months

  2. Frequency and percentage of the longest feasible fasting period prior to chemotherapy

    Measured: 4 months

  3. Overall toxicity incidence and profiles by fasting time and patient as per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0

    Analyzed by frequency distributions, graphical techniques, and other descriptive measures.

    Measured: 4 months

  4. Change in toxicity as assessed by Side Effect Questionnaire and descriptive statistics

    Assessing symptoms (with 0 being not at all and 10 being as bad as it can be), fasting difficulty (with 0 being very easy and 10 being extremely difficult), and willingness (with 0 being very willing and 10 being not willing at all).

    Measured: Baseline and 4 months

  5. Changes in levels of plasma glucose, insulin, IGF-1 and IGF-1BP in subjects who undertake short-term fasting by descriptive statistics

    Measured: Baseline and 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2010 (estimated)
  2. Study start13 Aug 2010
  3. Primary completion2 May 2013
  4. Study completion10 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01175837
Sponsor's protocol ID
MC09C3
Other IDs
NCI-2010-01572, MC09C3, P30CA015083
Status last verified
Dec 2018
First submitted
14 Jul 2010
Last updated
12 Dec 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing questionnaire administration, preventative dietary intervention and laboratory biomarker analysis in people with Malignant Neoplasm, run by Mayo Clinic at 1 site in United States.

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 13 inclusion and 23 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 12 Dec 2018. 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 United States. 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?

Number of patients hospitalized during fasting period (for reasons that are not attributed to disease or post-operative complications) (time frame: Up to 48 hours). The study lists 3 primary outcomes in all. 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 NCT01175837.

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 12 Dec 2018.

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