Cancer SurvivorNExTNCT03489213
Nutrition and Exercise Trial: Improving Diet and Physical Activity Patterns in Overweight Cancer Survivors
A study testing Dietary Intervention, Exercise Intervention and Laboratory Biomarker Analysis in people with Cancer Survivor and Overweight, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This randomized phase II trial will enroll overweight cancer survivors. Subjects in both groups will be educated to follow a diet pattern similar to what is recommended by the Dietary Guidelines for Americans and the American Institute for Cancer Research (DGA/AICR) but one group will also receive 18 ounces of lean… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Survivor, Overweight
- What is being tested?
- Dietary Intervention, Exercise Intervention and Laboratory Biomarker Analysis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2017to 1 Jun 2019
- 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
- Have a body mass index (BMI) >= 25 kg/m^2
- Be non-vegetarian/non-vegan, and have no concerns with beef consumption
- Have completed active curative therapy for cancer within the past 36 months (i.e., surgery, chemotherapy, or radiation); ongoing hormone therapy is acceptable
- Voluntarily provide consent, Health Insurance Portability and Accountability Act (HIPPA) authorization form, and consent from primary care provider (PCP) or treating oncologist
- Not be planning to travel for more than 3 consecutive weeks during the intervention period
- Agree to refrain from all nutritional supplements, herbal supplements, and botanical supplements aside from those prescribed by a physician for the duration of the study
Who cannot join
- Are cognitively unable to consent or have physical or mental limitations that would prevent full participation in the program
- Are vegan or those unwilling to consume 11-18 ounces (oz) of beef per week
- Have pre-existing medical conditions that preclude unsupervised physical activity (i.e., severe orthopedic conditions, impending hip or knee replacement, paralysis, unstable angina, dementia, recent history of myocardial infarction, congestive heart failure, pulmonary conditions requiring oxygen, or hospitalization in past 6 months)
- Have had cancer treatment that significantly impacts digestion, metabolism, or food intake (e.g., surgical loss of esophagus, stomach, or colon, pancreas dysfunction, or brain surgery that alters cognition, etc.)
- Report meeting the recommendations for physical activity (> 60 minutes per day, most days per week) and already meet the majority of dietary guidelines as assessed by a telephone screener
- Are prescribed medication that do not allow for increased intake of fruits and vegetables
Show all 9Show fewer
- Have recently (< 3 months) started a statin or other lipid lowering medication; participants who report that they are changing a lipid lowering drug dose or drug type during the recruitment period will also be excluded; participants who have been stable on a lipid-lowering medication for at least 3 months may participate; well-controlled diabetics (type I or II) may participate
- Have been diagnosed with active metabolic or digestive illnesses (i.e., Celiac disease, irritable bowel syndrome [IBS], renal insufficiency, hepatic insufficiency)
- Are pregnant or are planning to become pregnant during the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: NExT (Nutrition and Exercise Cancer Survivor Trial)
This randomized phase II trial will enroll overweight cancer survivors. Subjects in both groups will be educated to follow a diet pattern similar to what is recommended by the Dietary Guidelines for Americans and the American Institute for Cancer Research (DGA/AICR) but one group will also receive 18 ounces of lean beef for incorporation into a healthy diet. Subjects will be encouraged to exercise regularly and activity will be monitored throughout the study. Nutrition and exercise may help cancer survivors successfully maintain improved dietary patterns, body composition, and physical activity efforts and consumption of beef may favorably impact lean body mass and specific nutritional outcomes.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility and compliance with a the Dietary Guidelines for Americans/American Institute for Cancer Research (DGA/AICR) healthy dietary pattern and a beef + DGA/AICR healthy dietary pattern in cancer survivors.
II. To determine the impact of dietary interventions on body composition, clinical outcomes, and physical performance.
III. To quantify the impact of the two dietary interventions on cardiometabolic biomarkers of health.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive DGA/AICR-based dietary intervention for 6 months consisting of 12 education sessions over 60 minutes every other week, fruit, vegetable, and herb harvesting 1-2 times per week for 2 hours, wearing a FitBit during physical activity, and remote health coaching over 10 minutes for 12 weeks.
ARM II: Patients receive DGA/AICR-based dietary intervention as in Arm I and consume 11-18 ounces of lean beef each week for 6 months.
Clinical and physical activity assessments will take place at baseline, after the intervention and at 12 months.
- Conditions
- Cancer Survivor, Overweight
- Being tested
- Dietary Intervention, Exercise Intervention, Laboratory Biomarker Analysis, Nutritional Intervention, Questionnaire Administration
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionOther
Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions
Participants randomized to the DGA/AICR group will receive plant-based diet education, garden access and health coaching for 5 months. The sessions are offered every other week.
Exercise InterventionBehavioural
Participants will wear a FitBit every day and monitor daily physical activity.
Laboratory Biomarker AnalysisOther
Correlative studies
Nutritional InterventionDietary supplement
Participants randomized to the beef group will receive 11 to 18 ounces of frozen lean beef each week for home preparation, in addition to DGA/AICR diet education, garden access and health coaching.
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (DGA/AICR) | Active comparator | Patients receive DGA/AICR-based dietary intervention for 6 months consisting of 12 education sessions (60 minutes each) every other week. Lectures will take place in an urban garden where fruit, vegetable, and herb harvesting 1-2 times per week is encouraged. All participants will be given a FitBit and regular physical activity will be encouraged. Finally, remote health coaching is offered to all study subjects for the duration of the intervention (12 weeks). Receives: Other: Dietary Intervention; Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Dietary Supplement: Nutritional Intervention; Other: Questionnaire Administration |
| Arm II (DGA/AICR plus Beef) | Experimental | Patients receive the same intervention as in Arm I with the addition of 18 ounces of lean beef provided by the study to each subject. Subjects will be encouraged to consume the lean beef and lectures will incorporate healthy beef consumption into each lesson and cooking demonstration. Receives: Other: Dietary Intervention; Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Dietary Supplement: Nutritional Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to either the DGA/AICR group or the DGA/AICR + Beef group
Participants will keep both 7 day diet records periodically through out the study as well as a daily log of beef consumption
Measured: Up to 12 months
Change in body composition
Change in body composition will be assessed by dual X-ray absorptiometry (iDXA)
Measured: Up to 12 months
Change in blood pressure
Trained personnel will use a sphygomanometer to assess blood pressure
Measured: Baseline up to 12 months
Change in body mass index (BMI)
Weight and height will be combined to report BMI in kg/m^2.
Measured: Baseline up to 12 months
Change in dietary carotenoid intake
Assessed by Raman spectroscopy
Measured: Baseline up to 12 months
Change in blood carotenoids
Assessed by High Pressure Liquid Chromatography
Measured: Up to 12 months
Change in physical performance assessed by timed performance-related mobility tasks
Physical performance will be measured using the 40 M walk test
Measured: Baseline up to 12 months
Change in physical performance
Assessed by a standardized stair climb test
Measured: Up to 12 months
Dietary intake patterns
Will be assessed using diet logs maintained throughout the intervention and graphical food frequency questionnaire (FFQ). This FFQ automatically calculates the Healthy Eating Index 2010. Will use previous 30-day intake for all FFQs to assess dietary patterns. To determine protein balance, will use a 7-day diet record prior to a 24-hr urine collection.
Measured: Up to 6 months
Adherence to classes
Descriptive statistics will be generated using attendance forms
Measured: Up to 12 months
Change in fasting glucose
A fasting blood sample will be used to measure glucose at three time points
Measured: Up to 12 months
Change in lipoprotein profiles
A fasting blood sample will be used to assess serum lipoprotein profile
Measured: Up to 12 months
Daily physical activity (steps per day)
Each participants daily FitBit data will be downloaded to a secure spreadsheet
Measured: up to 12 months
Secondary outcomes (1)
Health related quality of life
Measured at all three time points using the Health Related Quality of Life (HR-QOL) questionnaire
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start25 Apr 2017
- Primary completion1 Jun 2018
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cancer SurvivorStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Clinton, Ohio State University Comprehensive Cancer Center
- Investigators
- Steven Clinton, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489213
- Sponsor's protocol ID
- OSU-17012
- Other IDs
- NCI-2017-01031
- Acronym
- NExT
- Status last verified
- Aug 2019
- First submitted
- 9 Feb 2018
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hill EB, Pashkova A, Grainger EM, Roberts KM, Chitchumroonchokchai C, Braun AC, Ralston RA, Riedl KM, Spees CK, Clinton SK. Targeted Urinary Profiling as a Biomarker of Dietary Flavonoid Intake from Fruits and Vegetables and its Relationship to the Timing of Dietary Assessment. Curr Dev Nutr. 2025 Jul 31;9(9):107520. doi: 10.1016/j.cdnut.2025.107520. eCollection 2025 Sep.
PubMed 41080470Braun AC, Portner J, Grainger EM, Clinton SK, Xu M, Darragh A, Pratt KJ, Weaver LL, Spees CK. Impact of Dietitian-Delivered Motivational Interviewing Within a Food is Medicine Intervention Targeting Adults Living With and Beyond Cancer. J Cancer Educ. 2025 Aug;40(4):609-615. doi: 10.1007/s13187-024-02552-4. Epub 2024 Dec 21.
PubMed 39708224
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NExT (Nutrition and Exercise Cancer Survivor Trial)
- ClinicalTrials.gov ID
- NCT03489213
- Acronym / sponsor ID
- NExT / OSU-17012
- Conditions
- Cancer Survivor, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 5 Apr 2018 (actual)
- 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.
This randomized phase II trial will enroll overweight cancer survivors. Subjects in both groups will be educated to follow a diet pattern similar to what is recommended by the Dietary Guidelines for Americans and the American Institute for Cancer Research (DGA/AICR) but one group will also receive 18 ounces of lean beef for incorporation into a healthy diet. Subjects will be encouraged to exercise regularly and activity will be monitored throughout the study. Nutrition and exercise may help cancer survivors successfully maintain improved dietary patterns, body composition, and physical activity efforts and consumption of beef may favorably impact lean body mass and specific nutritional outcomes.
Detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility and compliance with a the Dietary Guidelines for Americans/American Institute for Cancer Research (DGA/AICR) healthy dietary pattern and a beef + DGA/AICR healthy dietary pattern in cancer survivors.
II. To determine the impact of dietary interventions on body composition, clinical outcomes, and physical performance.
III. To quantify the impact of the two dietary interventions on cardiometabolic biomarkers of health.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive DGA/AICR-based dietary intervention for 6 months consisting of 12 education sessions over 60 minutes every other week, fruit, vegetable, and herb harvesting 1-2 times per week for 2 hours, wearing a FitBit during physical activity, and remote health coaching over 10 minutes for 12 weeks.
ARM II: Patients receive DGA/AICR-based dietary intervention as in Arm I and consume 11-18 ounces of lean beef each week for 6 months.
Clinical and physical activity assessments will take place at baseline, after the intervention and at 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (DGA/AICR) | Active comparator | Other: Dietary Intervention, Behavioral: Exercise Intervention, Other: Laboratory Biomarker Analysis, Dietary Supplement: Nutritional Intervention, Other: Questionnaire AdministrationPatients receive DGA/AICR-based dietary intervention for 6 months consisting of 12 education sessions (60 minutes each) every other week. Lectures will take place in an urban garden where fruit, vegetable, and herb harvesting 1-2 times per week is encouraged. All participants will be given a FitBit and regular physical activity will be encouraged. Finally, remote health coaching is offered to all study subjects for the duration of the intervention (12 weeks). |
| Arm II (DGA/AICR plus Beef) | Experimental | Other: Dietary Intervention, Behavioral: Exercise Intervention, Other: Laboratory Biomarker Analysis, Dietary Supplement: Nutritional Intervention, Other: Questionnaire AdministrationPatients receive the same intervention as in Arm I with the addition of 18 ounces of lean beef provided by the study to each subject. Subjects will be encouraged to consume the lean beef and lectures will incorporate healthy beef consumption into each lesson and cooking demonstration. |
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 a body mass index (BMI) >= 25 kg/m^2
- Be non-vegetarian/non-vegan, and have no concerns with beef consumption
- Have completed active curative therapy for cancer within the past 36 months (i.e., surgery, chemotherapy, or radiation); ongoing hormone therapy is acceptable
- Voluntarily provide consent, Health Insurance Portability and Accountability Act (HIPPA) authorization form, and consent from primary care provider (PCP) or treating oncologist
- Not be planning to travel for more than 3 consecutive weeks during the intervention period
Key exclusion criteria (9 listed)
- Are cognitively unable to consent or have physical or mental limitations that would prevent full participation in the program
- Are vegan or those unwilling to consume 11-18 ounces (oz) of beef per week
- Have pre-existing medical conditions that preclude unsupervised physical activity (i.e., severe orthopedic conditions, impending hip or knee replacement, paralysis, unstable angina, dementia, recent history of myocardial infarction, congestive heart failure, pulmonary conditions requiring oxygen, or hospitalization in past 6 months)
- Have had cancer treatment that significantly impacts digestion, metabolism, or food intake (e.g., surgical loss of esophagus, stomach, or colon, pancreas dysfunction, or brain surgery that alters cognition, etc.)
- Report meeting the recommendations for physical activity (> 60 minutes per day, most days per week) and already meet the majority of dietary guidelines as assessed by a telephone screener
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 |
|---|---|---|
| Dietary InterventionAlso: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition InterventionsParticipants randomized to the DGA/AICR group will receive plant-based diet education, garden access and health coaching for 5 months. The sessions are offered every other week. | Other | Arm I (DGA/AICR), Arm II (DGA/AICR plus Beef) |
| Exercise InterventionParticipants will wear a FitBit every day and monitor daily physical activity. | Behavioural | Arm I (DGA/AICR), Arm II (DGA/AICR plus Beef) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I (DGA/AICR), Arm II (DGA/AICR plus Beef) |
| Nutritional InterventionParticipants randomized to the beef group will receive 11 to 18 ounces of frozen lean beef each week for home preparation, in addition to DGA/AICR diet education, garden access and health coaching. | Dietary supplement | Arm I (DGA/AICR), Arm II (DGA/AICR plus Beef) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (DGA/AICR), Arm II (DGA/AICR plus Beef) |
Primary outcome
Adherence to either the DGA/AICR group or the DGA/AICR + Beef group
Time frame: Up to 12 months
Participants will keep both 7 day diet records periodically through out the study as well as a daily log of beef consumption
Change in body composition
Time frame: Up to 12 months
Change in body composition will be assessed by dual X-ray absorptiometry (iDXA)
Change in blood pressure
Time frame: Baseline up to 12 months
Trained personnel will use a sphygomanometer to assess blood pressure
Change in body mass index (BMI)
Time frame: Baseline up to 12 months
Weight and height will be combined to report BMI in kg/m^2.
Change in dietary carotenoid intake
Time frame: Baseline up to 12 months
Assessed by Raman spectroscopy
Change in blood carotenoids
Time frame: Up to 12 months
Assessed by High Pressure Liquid Chromatography
Change in physical performance assessed by timed performance-related mobility tasks
Time frame: Baseline up to 12 months
Physical performance will be measured using the 40 M walk test
Change in physical performance
Time frame: Up to 12 months
Assessed by a standardized stair climb test
Dietary intake patterns
Time frame: Up to 6 months
Will be assessed using diet logs maintained throughout the intervention and graphical food frequency questionnaire (FFQ). This FFQ automatically calculates the Healthy Eating Index 2010. Will use previous 30-day intake for all FFQs to assess dietary patterns. To determine protein balance, will use a 7-day diet record prior to a 24-hr urine collection.
Adherence to classes
Time frame: Up to 12 months
Descriptive statistics will be generated using attendance forms
Change in fasting glucose
Time frame: Up to 12 months
A fasting blood sample will be used to measure glucose at three time points
Change in lipoprotein profiles
Time frame: Up to 12 months
A fasting blood sample will be used to assess serum lipoprotein profile
Daily physical activity (steps per day)
Time frame: up to 12 months
Each participants daily FitBit data will be downloaded to a secure spreadsheet
1 secondary outcome
Health related quality of life
Time frame: Up to 12 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 30 Aug 2019.
- Derived from this study: PubMed 41080470Hill EB, Pashkova A, Grainger EM, Roberts KM, Chitchumroonchokchai C, Braun AC, Ralston RA, Riedl KM, Spees CK, Clinton SK. Targeted Urinary Profiling as a Biomarker of Dietary Flavonoid Intake from Fruits and Vegetables and its Relationship to the Timing of Dietary Assessment. Curr Dev Nutr. 2025 Jul 31;9(9):107520. doi: 10.1016/j.cdnut.2025.107520. eCollection 2025 Sep.
- Derived from this study: PubMed 39708224Braun AC, Portner J, Grainger EM, Clinton SK, Xu M, Darragh A, Pratt KJ, Weaver LL, Spees CK. Impact of Dietitian-Delivered Motivational Interviewing Within a Food is Medicine Intervention Targeting Adults Living With and Beyond Cancer. J Cancer Educ. 2025 Aug;40(4):609-615. doi: 10.1007/s13187-024-02552-4. Epub 2024 Dec 21.
- The JameslineLink provided by the sponsor.
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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.
Steven Clinton, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Intervention, Exercise Intervention and Laboratory Biomarker Analysis in people with Cancer Survivor and Overweight, run by Ohio State University Comprehensive Cancer Center 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 9 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 30 Aug 2019. 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?
Adherence to either the DGA/AICR group or the DGA/AICR + Beef group (time frame: Up to 12 months). The study lists 13 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 NCT03489213, which also lists 2 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 30 Aug 2019.