Lifestyle Change for Better Health

Bladder Cancer Clinical Trial

— LCBH  

Official title:

Leukocyte Telomere Length: Diet and Exercise Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03286699
• Other study ID #: STUDY19070303
• Secondary ID: R21CA212628
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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) compared to a diet only intervention.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 84 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Adenoma
• Bladder Cancer
• Colorectal Adenoma
• Telomere Shortening

Intervention

Behavioral:
• Dietary Intervention
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 Intervention
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.

Locations

Country	Name	City	State
United States	UPMC Shadyside	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body Mass Index (BMI) at 3 months (controlling for appropriate covariates)	BMI will be calculated from height and weight measurements	Measurements will be collected as part of the 3 month assessment
Other	Body Mass Index (BMI) at 6 months (controlling for appropriate covariates)	BMI will be calculated from height and weight measurements	Measurements will be collected as part of the 6 month assessment
Other	Body composition at 3 months (controlling for appropriate covariates)	Body composition will be measured by dual-energy x-ray absorptiometry (DXA)	Measurements will be collected as part of the 3 month assessment
Other	Body composition at 6 months (controlling for appropriate covariates)	Body composition will be measured by dual-energy x-ray absorptiometry (DXA)	Measurements will be collected as part of the 6 month assessment
Other	Regional adiposity (DXA) at 3 months (controlling for appropriate covariates)	Regional adiposity will be measured by dual-energy x-ray absorptiometry (DXA)	Measurements will be collected as part of the 3 month assessment
Other	Regional adiposity (DXA) at 6 months (controlling for appropriate covariates)	Regional adiposity will be measured by dual-energy x-ray absorptiometry (DXA)	Measurements will be collected as part of the 6 month assessment
Other	Waist-to-hip ratio at 3 months (controlling for appropriate covariates)	Waist-to-hip ratio will be calculated from waist and hip measurements	Measurements will be collected as part of the 3 month assessment
Other	Waist-to-hip ratio at 6 months (controlling for appropriate covariates)	Waist-to-hip ratio will be calculated from waist and hip measurements	Measurements will be collected as part of the 6 month assessment
Other	Objective physical activity level at 3 months (controlling for appropriate covariates)	Physical Activity will be objectively measured with SenseWear BodyMedia	Total physical activity will be calculated from measurements collected for 7 consecutive days following the 3 month assessment
Other	Objective physical activity level at 6 months (controlling for appropriate covariates)	Physical Activity will be objectively measured with SenseWear BodyMedia	Total physical activity will be calculated from measurements collected for 7 consecutive days following the 6 month assessment
Other	Self-reported physical activity level at 3 months (controlling for appropriate covariates)	The Paffenbarger Physical Activity Questionnaire will be used to obtain a self-reported measure of physical activity	Self-reports will be obtained as part of the 3 month assessment
Other	Self-reported physical activity level at 6 months (controlling for appropriate covariates)	The Paffenbarger Physical Activity Questionnaire will be used to obtain a self-reported measure of physical activity	Self-reports will be obtained as part of the 6 month assessment
Other	Cardiorespiratory fitness at 3 months (controlling for appropriate covariates)	Cardiorespiratory Fitness (oxygen consumption) will be measured by submaximal treadmill test	Measurements will be collected as part of the 3 month assessment
Other	Cardiorespiratory fitness at 6 months (controlling for appropriate covariates)	Cardiorespiratory Fitness (oxygen consumption) will be measured by submaximal treadmill test	Measurements will be collected as part of the 6 month assessment
Other	Depressive symptoms at 3 months (controlling for appropriate covariates)	The Center for Epidemiologic Studies Depression Scale will be used to obtain a self-reported measure of depressive symptoms	Questionnaires will be completed as part of the 3 month assessment
Other	Depressive symptoms at 6 months (controlling for appropriate covariates)	The Center for Epidemiologic Studies Depression Scale will be used to obtain a self-reported measure of depressive symptoms	Questionnaires will be completed as part of the 6 month assessment
Other	Symptoms of anxiety at 3 months (controlling for appropriate covariates)	The State subscale of the State Trait Anxiety Inventory will be used to obtain a self-reported measure of acute anxiety	Questionnaires will be completed as part of the 3 month assessment
Other	Symptoms of anxiety at 6 months (controlling for appropriate covariates)	The State subscale of the State Trait Anxiety Inventory will be used to obtain a self-reported measure of acute anxiety	Questionnaires will be completed as part of the 6 month assessment
Other	Perceived stress at 3 months (controlling for appropriate covariates)	The Perceived Stress Scale will be used to obtain a self-reported measure of perceived stress	Questionnaires will be completed as part of the 3 month assessment
Other	Perceived stress at 6 months (controlling for appropriate covariates)	The Perceived Stress Scale will be used to obtain a self-reported measure of perceived stress	Questionnaires will be completed as part of the 6 month assessment
Other	Sleep quality at 3 months (controlling for appropriate covariates)	The Pittsburgh Sleep Quality Index will be used to obtain a self-reported measure of overall sleep quality	Questionnaires will be completed as part of the 3 month assessment
Other	Sleep quality at 6 months (controlling for appropriate covariates)	The Pittsburgh Sleep Quality Index will be used to obtain a self-reported measure of overall sleep quality	Questionnaires will be completed as part of the 6 month assessment
Other	Quality of life at 3 months (controlling for appropriate covariates)	The Functional Assessment of Cancer Therapy - Bladder Cancer will be used to obtain a self-reported measure of health-related quality of life	Questionnaires will be completed as part of the 3 month assessment
Other	Quality of life at 6 months (controlling for appropriate covariates)	The Functional Assessment of Cancer Therapy - Bladder Cancer will be used to obtain a self-reported measure of health-related quality of life	Questionnaires will be completed as part of the 6 month assessment
Primary	Leukocyte telomere length (LTL) at the 6 month assessment (controlling for appropriate covariates)	LTL will be measured in blood samples from participants	Blood samples will be collected as part of the 6 month assessment
Secondary	Leukocyte telomere length (LTL) at the 3 month assessment (controlling for appropriate covariates)	LTL will be measured in blood samples from participants	Blood samples will be collected as part of the 3 month assessment
Secondary	Leukocyte telomere length (LTL) at the 12 month assessment (controlling for appropriate covariates)	LTL will be measured in blood samples from participants	Blood samples will be collected as part of the 12 month assessment (as feasible)
Secondary	Telomerase level at 3 months (controlling for appropriate covariates)	Telomerase will be measured in blood samples from participants	Blood samples will be collected as part of the 3 month assessment
Secondary	Telomerase level at 6 months (controlling for appropriate covariates)	Telomerase will be measured in blood samples from participants	Blood samples will be collected as part of the 6 month assessment
Secondary	Telomerase level at 12 months (controlling for appropriate covariates)	Telomerase will be measured in blood samples from participants	Blood samples will be collected as part of the 12 month assessment (as feasible)
Secondary	8-OHdG level at 3 months (controlling for appropriate covariates)	8-OHdG will be measured in samples from participants	Samples will be collected as part of the 3 month assessment
Secondary	8-OHdG level at 6 months (controlling for appropriate covariates)	8-OHdG will be measured in samples from participants	Samples will be collected as part of the 6 month assessment
Secondary	Superoxide dismutase 1 (SOD1) at 3 months (controlling for appropriate covariates)	SOD1 will be measured in samples from participants	Samples will be collected as part of the 3 month assessment
Secondary	Superoxide dismutase 1 (SOD1) at 6 months (controlling for appropriate covariates)	SOD1 will be measured in samples from participants	Samples will be collected as part of the 6 month assessment
Secondary	Superoxide dismutase 2 (SOD2) at 3 months (controlling for appropriate covariates)	SOD2 will be measured in samples from participants	Samples will be collected as part of the 3 month assessment
Secondary	Superoxide dismutase 2 (SOD2) at 6 months (controlling for appropriate covariates)	SOD2 will be measured in samples from participants	Samples will be collected as part of the 6 month assessment
Secondary	Glutathione peroxidase (Gpx) at 3 months (controlling for appropriate covariates)	Gpx will be measured in samples from participants	Samples will be collected as part of the 3 month assessment
Secondary	Glutathione peroxidase (Gpx) at 6 months (controlling for appropriate covariates)	Gpx will be measured in samples from participants	Samples will be collected as part of the 6 month assessment
Secondary	Systemic Inflammatory Response (SIR) at 3 months (controlling for appropriate covariates)	SIR will be measured in samples from participants	Samples will be collected as part of the 3 month assessment
Secondary	Systemic Inflammatory Response (SIR) at 6 months (controlling for appropriate covariates)	SIR will be measured in samples from participants	Samples will be collected as part of the 6 month assessment