Cancer SurvivorshipNCT04243512
Time-restricted Eating in Cancer Survivorship: A Single-arm Feasibility Pilot Study
A study testing Time-restricted eating in people with Cancer Survivorship, run by University of Rochester at 1 site in United States.
Trial summary
The investigators will assess the feasibility of delivering a time-restricted eating (TRE) intervention among cancer survivors with fatigue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Survivorship
- What is being tested?
- Time-restricted eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2020to 29 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Have completed adjuvant chemotherapy, surgery, and/or radiation for cancer at least 4 months and not more than 5 years prior to enrolling,
- Have a baseline level of fatigue, as determined by reporting a score of 3 or higher for the question, "In the last week, how bad was your worst fatigue on a scale from 0-10?"
- Be able to speak English,
- Be at least 18 years old,
- Be willing and able to adhere to study procedures, and
- Be able to provide written informed consent.
Who cannot join
- Already eat all their food within a window that is 10 h or shorter most (6/7) days of the week,
- Be underweight, as defined as a body mass index ≤20.0 kg/m2.
- Not have surgery planned in the next month,
- Not have any contraindications to the proposed nutrition intervention as identified by
- their medical provider, their designee, or the study team (e.g., type 1 diabetes, risk for hypoglycemia, medication requirements, pregnancy, breastfeeding, recent history of an eating disorder),
- Not be taking insulin, or
- Be on enteral or parenteral nutrition.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators will assess the feasibility of delivering a time-restricted eating (TRE) intervention among cancer survivors with fatigue.
Read the detailed description
In this study, the feasibility of delivering a time-restricted eating (TRE) intervention among fatigued cancer survivors will be assessed. The participants will be asked to eat ad libitum only within a self-selected 10-h window each day for 14 days. The primary aim is to assess the adherence of the participants to the 10-h TRE intervention.
- Conditions
- Cancer Survivorship
- Being tested
- Time-restricted eating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-restricted eatingBehavioural
Restrict food and beverage intake (except water) to a 10-hour window
| Study group | Role | What they receive |
|---|---|---|
| Time-restricted eating | Experimental | Participants will be asked to follow a TRE meal pattern for 14 consecutive days. Participants will be encouraged to consume food and beverages only within a 10-h time window for the 14-day intervention, with the exception of water, which will be encouraged at any time. Receives: Behavioral: Time-restricted eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent of Days That Participants Adhere to the TRE Dietary Pattern
Adherence will be assessed as the percent of days that each participant adheres to the 10-h TRE dietary pattern
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start30 Jun 2020
- Primary completion1 Sep 2021
- Study completion29 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer SurvivorshipStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amber Kleckner, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243512
- Sponsor's protocol ID
- UMLT19187
- Status last verified
- Jun 2022
- First submitted
- 24 Jan 2020
- Last updated
- 11 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kleckner AS, Altman BJ, Reschke JE, Kleckner IR, Culakova E, Dunne RF, Mustian KM, Peppone LJ. Time-restricted Eating to Address Cancer-related Fatigue among Cancer Survivors: A Single-arm Pilot Study. J Integr Oncol. 2022;11(5):379. Epub 2022 May 30.
PubMed 36131848
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-restricted Eating in Cancer Survivorship: A Single-arm Feasibility Pilot Study
- ClinicalTrials.gov ID
- NCT04243512
- Acronym / sponsor ID
- UMLT19187
- Conditions
- Cancer Survivorship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 29 Jun 2022 (actual)
- First posted
- 28 Jan 2020 (actual)
- Results
- Posted 11 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will assess the feasibility of delivering a time-restricted eating (TRE) intervention among cancer survivors with fatigue.
Detailed description
In this study, the feasibility of delivering a time-restricted eating (TRE) intervention among fatigued cancer survivors will be assessed. The participants will be asked to eat ad libitum only within a self-selected 10-h window each day for 14 days. The primary aim is to assess the adherence of the participants to the 10-h TRE intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Time-restricted eating | Experimental | Behavioral: Time-restricted eatingParticipants will be asked to follow a TRE meal pattern for 14 consecutive days. Participants will be encouraged to consume food and beverages only within a 10-h time window for the 14-day intervention, with the exception of water, which will be encouraged at any time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have completed adjuvant chemotherapy, surgery, and/or radiation for cancer at least 4 months and not more than 5 years prior to enrolling,
- Have a baseline level of fatigue, as determined by reporting a score of 3 or higher for the question, "In the last week, how bad was your worst fatigue on a scale from 0-10?"
- Be able to speak English,
- Be at least 18 years old,
- Be willing and able to adhere to study procedures, and
Key exclusion criteria (7 listed)
- Already eat all their food within a window that is 10 h or shorter most (6/7) days of the week,
- Be underweight, as defined as a body mass index ≤20.0 kg/m2.
- Not have surgery planned in the next month,
- Not have any contraindications to the proposed nutrition intervention as identified by
- their medical provider, their designee, or the study team (e.g., type 1 diabetes, risk for hypoglycemia, medication requirements, pregnancy, breastfeeding, recent history of an eating disorder),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time-restricted eatingRestrict food and beverage intake (except water) to a 10-hour window | Behavioural | Time-restricted eating |
Primary outcome
Mean Percent of Days That Participants Adhere to the TRE Dietary Pattern
Time frame: 14 days
Adherence will be assessed as the percent of days that each participant adheres to the 10-h TRE dietary pattern
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36131848Kleckner AS, Altman BJ, Reschke JE, Kleckner IR, Culakova E, Dunne RF, Mustian KM, Peppone LJ. Time-restricted Eating to Address Cancer-related Fatigue among Cancer Survivors: A Single-arm Pilot Study. J Integr Oncol. 2022;11(5):379. Epub 2022 May 30.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time-restricted eating in people with Cancer Survivorship, run by University of Rochester 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 6 inclusion and 7 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 11 May 2023. 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?
Yes. Results are posted in the registry (first posted 11 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Percent of Days That Participants Adhere to the TRE Dietary Pattern (time frame: 14 days). 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 NCT04243512, which also lists 1 linked publication.
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 11 May 2023.