Bladder CancerDEALNCT02716623
The Feasibility of a Diet and Exercise Intervention in Diabetics During Treatment for Non-muscle Invasive Bladder Cancer
A study testing CR diet and Exercise in people with Bladder Cancer and Diabetes Mellitus, run by University of Kansas Medical Center at 2 sites in United States.
Trial summary
The purpose of this study is to learn if bladder cancer patients can follow a diet and exercise program during treatment and whether the program will improve results of their treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Diabetes Mellitus
- What is being tested?
- CR diet and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2016to 1 May 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
- Diagnosis of non-muscle-invasive bladder cancer
- Have completed Transurethral Resection of Bladder Tumor (TURBT) procedure
- Diagnosis of diabetes or pre-diabetes, or use diabetic medication, or show signs of diabetes which would prompt a diabetic screening
Who cannot join
- Evidence of muscle-invasion or metastatic disease
- BMI less than 18.5 and/or score in the "severe malnourished" category of the patient generated subjective global assessment (PGSGA)
- Unable to complete the exercise regimen or deemed a fall risk
- Participating in a research study involving any form of treatment intervention
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kansas Cancer Center
Kansas City, Kansas, 66160
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The purpose of this study is to learn if bladder cancer patients can follow a diet and exercise program during treatment and whether the program will improve results of their treatment.
Read the detailed description
This study will examine the effects of a carbohydrate restricted (CR) diet in bladder cancer patients with diabetes. The goal of this pilot study is to determine if the CR diet and exercise routine are feasible for this patient population to follow.
Participants in this study will receive meals tailored to their specific needs. A registered dietitian will work with them to establish guidelines for the meals and to follow their progress throughout the study.
Participants will be asked to be in this study for up to 12 months. A participant will be asked to make a total of 16 in-person visits over the course of 12 months.
- Conditions
- Bladder Cancer, Diabetes Mellitus
- Being tested
- CR diet, Exercise
- Medical subject headings
- Urinary Bladder Neoplasms, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CR dietOther
Also called Carbohydrate restricted diet
Diet consists of meals lower in carbohydrates but does not restrict the number of calories that participants can consume.
ExerciseBehavioural
Participants will be asked to undergo specific exercise schedule. Exercise will be tracked using a fitness device.
| Study group | Role | What they receive |
|---|---|---|
| CR Diet and Exercise | Experimental | Participants will be asked to follow specific diet intervention and exercise regimen. Receives: Other: CR diet; Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant compliance with study specific CR diet
Measure participant compliance with CR diet. Compliance will be measured through adherence to study diet. Study team members will regularly check in with participants to track weekly food data.
Measured: 12 months
Secondary outcomes (1)
Presence of Tumor M2-PK
Level of Tumor M2-PK will be assessed over the course the study.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study startMar 2016
- Primary completion1 May 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Eugene Lee, MD, University of Kansas Medical Center
- Investigators
- Eugene Lee, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02716623
- Sponsor's protocol ID
- STUDY00001802
- Other IDs
- UL1TR000001
- Acronym
- DEAL
- Status last verified
- Jul 2019
- First submitted
- 10 Mar 2016
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of a Diet and Exercise Intervention in Diabetics During Treatment for Non-muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT02716623
- Acronym / sponsor ID
- DEAL / STUDY00001802
- Conditions
- Bladder Cancer, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Mar 2016
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 23 Mar 2016 (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.
The purpose of this study is to learn if bladder cancer patients can follow a diet and exercise program during treatment and whether the program will improve results of their treatment.
Detailed description
This study will examine the effects of a carbohydrate restricted (CR) diet in bladder cancer patients with diabetes. The goal of this pilot study is to determine if the CR diet and exercise routine are feasible for this patient population to follow.
Participants in this study will receive meals tailored to their specific needs. A registered dietitian will work with them to establish guidelines for the meals and to follow their progress throughout the study.
Participants will be asked to be in this study for up to 12 months. A participant will be asked to make a total of 16 in-person visits over the course of 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CR Diet and Exercise | Experimental | Other: CR diet, Behavioral: ExerciseParticipants will be asked to follow specific diet intervention and exercise regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of non-muscle-invasive bladder cancer
- Have completed Transurethral Resection of Bladder Tumor (TURBT) procedure
- Diagnosis of diabetes or pre-diabetes, or use diabetic medication, or show signs of diabetes which would prompt a diabetic screening
Key exclusion criteria (4 listed)
- Evidence of muscle-invasion or metastatic disease
- BMI less than 18.5 and/or score in the "severe malnourished" category of the patient generated subjective global assessment (PGSGA)
- Unable to complete the exercise regimen or deemed a fall risk
- Participating in a research study involving any form of treatment intervention
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 |
|---|---|---|
| CR dietAlso: Carbohydrate restricted dietDiet consists of meals lower in carbohydrates but does not restrict the number of calories that participants can consume. | Other | CR Diet and Exercise |
| ExerciseParticipants will be asked to undergo specific exercise schedule. Exercise will be tracked using a fitness device. | Behavioural | CR Diet and Exercise |
Primary outcome
Participant compliance with study specific CR diet
Time frame: 12 months
Measure participant compliance with CR diet. Compliance will be measured through adherence to study diet. Study team members will regularly check in with participants to track weekly food data.
1 secondary outcome
Presence of Tumor M2-PK
Time frame: 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 15 Jul 2019.
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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.
Eugene Lee, MD principal investigator
University of Kansas Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CR diet and Exercise in people with Bladder Cancer and Diabetes Mellitus, run by University of Kansas Medical Center at 2 sites 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 3 inclusion and 4 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 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Participant compliance with study specific CR diet (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2019.