Bladder CancerLCBHNCT03286699
Lifestyle Change for Better Health
A study testing Dietary Intervention and Physical Activity Intervention in people with Bladder Cancer and Telomere Shortening, run by University of Pittsburgh at 1 site in United States.
Trial summary
The goal of the research is to provide a first critical test of the novel scientific idea that a combined diet and exercise intervention may ameliorate shortening of leukocyte telomere length (LTL) in individuals with histories of successfully treated non-metastatic bladder cancer (BC) or colorectal adenoma (CRA)… Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Bladder Cancer, Telomere Shortening, Colorectal Adenoma
- What is being tested?
- Dietary Intervention and Physical Activity Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 1 Oct 2024
- 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 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI between 25.0 to <40 kg/m2 (allows for use of assessments such as DXA to be included)
- History of histologically confirmed bladder cancer (non-metastatic) or colorectal adenoma
- Under clinical surveillance with no evidence of disease
Who cannot join
- WHO performance status 3-4 or deemed physically unable to participate by physician
- Currently pregnant or breastfeeding, were pregnant in the previous 6 months or breastfeeding in the previous 3 months, or planning pregnancy in the next year
- History of bariatric surgery
- Medical condition that could affect body weight (e.g., diabetes mellitus, hyperthyroidism, uncontrolled hypothyroidism, chronic renal insufficiency, chronic liver disease, gastrointestinal disorders including ulcerative colitis)
- Cancer diagnosis (other than bladder cancer or non-melanoma skin cancer) in the previous 5 years
- Current congestive heart failure, signs or symptoms indicative of an increased acute risk for a cardiovascular event
Show all 14Show fewer
- History of myocardial infarction, coronary artery bypass or angioplasty, conditions requiring chronic anticoagulation (recent or recurrent DVT)
- Resting systolic blood pressure of >160 mmHg or diastolic blood pressure >100 mmHg
- Eating disorder that would contraindicate weight loss or physical activity
- Alcohol or substance abuse
- Current treatment for psychiatric issues (e.g., depression, bipolar disorder) or taking daily or extended release psychotropic medications in the previous 12 months
- Report exercising more than 100 minutes per week over the past 3 months (NOTE: includes physical activity performed for sport, fitness, or recreational activity; physical activity performed as part of occupation or household chores is not included)
- Weight loss of greater than 5% or participating in a weight reduction diet in the past 3 months
- Report plans to relocate to a location not accessible to the study site or having employment, personal, or travel commitments that prohibit attendance to at least 80 percent of the scheduled intervention sessions and all of the scheduled assessments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Leukocyte Telomere Length: Diet and Exercise Trial
The goal of the research is to provide a first critical test of the novel scientific idea that a combined diet and exercise intervention may ameliorate shortening of leukocyte telomere length (LTL) in individuals with histories of successfully treated non-metastatic bladder cancer (BC) or colorectal adenoma (CRA) compared to a diet only intervention.
- Conditions
- Bladder Cancer, Telomere Shortening, Colorectal Adenoma
- Being tested
- Dietary Intervention, Physical Activity Intervention
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionBehavioural
The behavioral weight loss intervention strategies will not be limited to, self-monitoring, goal setting, problem solving, mastery skills, social support, and relapse prevention. Participants will receive a standard behavioral weight control program, delivered on a one-on-one basis. They will attend in-person sessions (~30-45 minutes) with time to: distribute intervention materials, interact with the participant, identify participants that need additional support, and conduct the intervention. Each in-person visit focuses on a specific behavioral topic related to weight loss to address eating behaviors. Subjects will also participate in phone calls with the interventionist (~10 minutes). Depending on the week, subjects will have between 10 and 45 minutes of total intervention contact.
Physical Activity InterventionBehavioural
The behavioral weight loss intervention strategies will not be limited to, self-monitoring, goal setting, problem solving, mastery skills, social support, and relapse prevention. Participants will receive a standard behavioral weight control program, delivered on a one-on-one basis. They will attend in-person sessions (~30-45 minutes) with time to: distribute intervention materials, interact with the participant, identify participants that need additional support, and conduct the intervention. Each in-person visit focuses on a specific behavioral topic related to weight loss to address physical activity behaviors. Subjects will also participate in phone calls with the interventionist (~10 minutes). Depending on the week, subjects will have 10 to 45 minutes of total intervention contact.
| Study group | Role | What they receive |
|---|---|---|
| DIET | Active comparator | This group will be prescribed a Dietary Intervention that reduces energy intake by 500-1000 kcal/day and induces a weight loss of approximately 1-2 pounds per week during the intervention, with the weight loss goal individualized to each participant. Receives: Behavioral: Dietary Intervention |
| DIET-PA | Active comparator | This group will be prescribed a Dietary Intervention that reduces energy intake by 500-1000 kcal/day and induces a weight loss of approximately 1-2 pounds per week during the intervention, with the weight loss goal individualized to each participant. In addition, this group will be prescribed moderate-intensity Physical Activity Intervention that will progressively increase to the goal of 250 minutes/week. Receives: Behavioral: Dietary Intervention; Behavioral: Physical Activity Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leukocyte telomere length (LTL) at the 6 month assessment (controlling for appropriate covariates)
LTL will be measured in blood samples from participants
Measured: Blood samples will be collected as part of the 6 month assessment
Secondary outcomes (15)
Leukocyte telomere length (LTL) at the 3 month assessment (controlling for appropriate covariates)
LTL will be measured in blood samples from participants
Measured: Blood samples will be collected as part of the 3 month assessment
Leukocyte telomere length (LTL) at the 12 month assessment (controlling for appropriate covariates)
LTL will be measured in blood samples from participants
Measured: Blood samples will be collected as part of the 12 month assessment (as feasible)
Telomerase level at 3 months (controlling for appropriate covariates)
Telomerase will be measured in blood samples from participants
Measured: Blood samples will be collected as part of the 3 month assessment
Telomerase level at 6 months (controlling for appropriate covariates)
Telomerase will be measured in blood samples from participants
Measured: Blood samples will be collected as part of the 6 month assessment
Telomerase level at 12 months (controlling for appropriate covariates)
Telomerase will be measured in blood samples from participants
Measured: Blood samples will be collected as part of the 12 month assessment (as feasible)
8-OHdG level at 3 months (controlling for appropriate covariates)
8-OHdG will be measured in samples from participants
Measured: Samples will be collected as part of the 3 month assessment
8-OHdG level at 6 months (controlling for appropriate covariates)
8-OHdG will be measured in samples from participants
Measured: Samples will be collected as part of the 6 month assessment
Superoxide dismutase 1 (SOD1) at 3 months (controlling for appropriate covariates)
SOD1 will be measured in samples from participants
Measured: Samples will be collected as part of the 3 month assessment
Superoxide dismutase 1 (SOD1) at 6 months (controlling for appropriate covariates)
SOD1 will be measured in samples from participants
Measured: Samples will be collected as part of the 6 month assessment
Superoxide dismutase 2 (SOD2) at 3 months (controlling for appropriate covariates)
SOD2 will be measured in samples from participants
Measured: Samples will be collected as part of the 3 month assessment
Superoxide dismutase 2 (SOD2) at 6 months (controlling for appropriate covariates)
SOD2 will be measured in samples from participants
Measured: Samples will be collected as part of the 6 month assessment
Glutathione peroxidase (Gpx) at 3 months (controlling for appropriate covariates)
Gpx will be measured in samples from participants
Measured: Samples will be collected as part of the 3 month assessment
Glutathione peroxidase (Gpx) at 6 months (controlling for appropriate covariates)
Gpx will be measured in samples from participants
Measured: Samples will be collected as part of the 6 month assessment
Systemic Inflammatory Response (SIR) at 3 months (controlling for appropriate covariates)
SIR will be measured in samples from participants
Measured: Samples will be collected as part of the 3 month assessment
Systemic Inflammatory Response (SIR) at 6 months (controlling for appropriate covariates)
SIR will be measured in samples from participants
Measured: Samples will be collected as part of the 6 month assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start1 Jun 2017
- Primary completion31 Dec 2020
- Study completion1 Oct 2024
Why it stopped: Due to challenges with recruitment, we were unable to complete recruitment as planned during the period we had funding to do so.
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 PittsburghThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Dana Bovbjerg, University of Pittsburgh
- Investigators
- Dana Bovbjerg, PhD, Principal investigator, University of PittsburghJohn Jakicic, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286699
- Sponsor's protocol ID
- STUDY19070303
- Other IDs
- R21CA212628
- Acronym
- LCBH
- Status last verified
- Jan 2025
- First submitted
- 31 Jan 2017
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leukocyte Telomere Length: Diet and Exercise Trial
- ClinicalTrials.gov ID
- NCT03286699
- Acronym / sponsor ID
- LCBH / STUDY19070303
- Conditions
- Bladder Cancer, Telomere Shortening, Colorectal Adenoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to challenges with recruitment, we were unable to complete recruitment as planned during the period we had funding to do so.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 18 Sep 2017 (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.
The goal of the research is to provide a first critical test of the novel scientific idea that a combined diet and exercise intervention may ameliorate shortening of leukocyte telomere length (LTL) in individuals with histories of successfully treated non-metastatic bladder cancer (BC) or colorectal adenoma (CRA) compared to a diet only intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DIET | Active comparator | Behavioral: Dietary InterventionThis group will be prescribed a Dietary Intervention that reduces energy intake by 500-1000 kcal/day and induces a weight loss of approximately 1-2 pounds per week during the intervention, with the weight loss goal individualized to each participant. |
| DIET-PA | Active comparator | Behavioral: Dietary Intervention, Behavioral: Physical Activity InterventionThis group will be prescribed a Dietary Intervention that reduces energy intake by 500-1000 kcal/day and induces a weight loss of approximately 1-2 pounds per week during the intervention, with the weight loss goal individualized to each participant. In addition, this group will be prescribed moderate-intensity Physical Activity Intervention that will progressively increase to the goal of 250 minutes/week. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI between 25.0 to <40 kg/m2 (allows for use of assessments such as DXA to be included)
- History of histologically confirmed bladder cancer (non-metastatic) or colorectal adenoma
- Under clinical surveillance with no evidence of disease
Key exclusion criteria (14 listed)
- WHO performance status 3-4 or deemed physically unable to participate by physician
- Currently pregnant or breastfeeding, were pregnant in the previous 6 months or breastfeeding in the previous 3 months, or planning pregnancy in the next year
- History of bariatric surgery
- Medical condition that could affect body weight (e.g., diabetes mellitus, hyperthyroidism, uncontrolled hypothyroidism, chronic renal insufficiency, chronic liver disease, gastrointestinal disorders including ulcerative colitis)
- Cancer diagnosis (other than bladder cancer or non-melanoma skin cancer) in the previous 5 years
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 InterventionThe behavioral weight loss intervention strategies will not be limited to, self-monitoring, goal setting, problem solving, mastery skills, social support, and relapse prevention. Participants will receive a standard behavioral weight control program, delivered on a one-on-one basis. They will attend in-person sessions (~30-45 minutes) with time to: distribute intervention materials, interact with the participant, identify participants that need additional support, and conduct the intervention. Each in-person visit focuses on a specific behavioral topic related to weight loss to address eating behaviors. Subjects will also participate in phone calls with the interventionist (~10 minutes). Depending on the week, subjects will have between 10 and 45 minutes of total intervention contact. | Behavioural | DIET, DIET-PA |
| Physical Activity InterventionThe behavioral weight loss intervention strategies will not be limited to, self-monitoring, goal setting, problem solving, mastery skills, social support, and relapse prevention. Participants will receive a standard behavioral weight control program, delivered on a one-on-one basis. They will attend in-person sessions (~30-45 minutes) with time to: distribute intervention materials, interact with the participant, identify participants that need additional support, and conduct the intervention. Each in-person visit focuses on a specific behavioral topic related to weight loss to address physical activity behaviors. Subjects will also participate in phone calls with the interventionist (~10 minutes). Depending on the week, subjects will have 10 to 45 minutes of total intervention contact. | Behavioural | DIET-PA |
Primary outcome
Leukocyte telomere length (LTL) at the 6 month assessment (controlling for appropriate covariates)
Time frame: Blood samples will be collected as part of the 6 month assessment
LTL will be measured in blood samples from participants
15 secondary outcomes
Leukocyte telomere length (LTL) at the 3 month assessment (controlling for appropriate covariates)
Time frame: Blood samples will be collected as part of the 3 month assessment
Leukocyte telomere length (LTL) at the 12 month assessment (controlling for appropriate covariates)
Time frame: Blood samples will be collected as part of the 12 month assessment (as feasible)
Telomerase level at 3 months (controlling for appropriate covariates)
Time frame: Blood samples will be collected as part of the 3 month assessment
Telomerase level at 6 months (controlling for appropriate covariates)
Time frame: Blood samples will be collected as part of the 6 month assessment
Telomerase level at 12 months (controlling for appropriate covariates)
Time frame: Blood samples will be collected as part of the 12 month assessment (as feasible)
8-OHdG level at 3 months (controlling for appropriate covariates)
Time frame: Samples will be collected as part of the 3 month assessment
8-OHdG level at 6 months (controlling for appropriate covariates)
Time frame: Samples will be collected as part of the 6 month assessment
Superoxide dismutase 1 (SOD1) at 3 months (controlling for appropriate covariates)
Time frame: Samples will be collected as part of the 3 month assessment
Superoxide dismutase 1 (SOD1) at 6 months (controlling for appropriate covariates)
Time frame: Samples will be collected as part of the 6 month assessment
Superoxide dismutase 2 (SOD2) at 3 months (controlling for appropriate covariates)
Time frame: Samples will be collected as part of the 3 month assessment
Superoxide dismutase 2 (SOD2) at 6 months (controlling for appropriate covariates)
Time frame: Samples will be collected as part of the 6 month assessment
Glutathione peroxidase (Gpx) at 3 months (controlling for appropriate covariates)
Time frame: Samples will be collected as part of the 3 month assessment
Glutathione peroxidase (Gpx) at 6 months (controlling for appropriate covariates)
Time frame: Samples will be collected as part of the 6 month assessment
Systemic Inflammatory Response (SIR) at 3 months (controlling for appropriate covariates)
Time frame: Samples will be collected as part of the 3 month assessment
Systemic Inflammatory Response (SIR) at 6 months (controlling for appropriate covariates)
Time frame: Samples will be collected as part of the 6 month assessment
Results and safety
The study was stopped early (reason given: Due to challenges with recruitment, we were unable to complete recruitment as planned during the period we had funding to do so.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- 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.
Dana Bovbjerg, PhD principal investigator
University of Pittsburgh
John Jakicic, PhD principal investigator
University of Pittsburgh
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 and Physical Activity Intervention in people with Bladder Cancer and Telomere Shortening, run by University of Pittsburgh 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 3 inclusion and 14 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: stopped early, as of the sponsor's last update on 10 Jan 2025. 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 was stopped early (reason given: Due to challenges with recruitment, we were unable to complete recruitment as planned during the period we had funding to do so.). Results are not available in the source record.
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?
Leukocyte telomere length (LTL) at the 6 month assessment (controlling for appropriate covariates) (time frame: Blood samples will be collected as part of the 6 month assessment). 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 10 Jan 2025.