NCT03270111

Brief Summary

The purpose of this second pilot study is to extend the feasibility demonstrated in NCT02963740 that the intervention achieves high levels of moderate to vigorous physical activity (MVI PA) and modulates risk biomarkers for breast cancer and cardiovascular disease in older, obese sedentary breast cancer survivors who are undergoing moderate calorie restriction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
24 days until next milestone

Study Start

First participant enrolled

September 25, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2018

Completed
Last Updated

December 18, 2024

Status Verified

December 1, 2024

Enrollment Period

10 months

First QC Date

August 30, 2017

Last Update Submit

December 16, 2024

Conditions

Breast Cancer Female

Keywords

breast cancer survivorweight loss program

Outcome Measures

Primary Outcomes (1)

  • Adherence to supervised exercise sessions

    Adherence is defined as the percent of monitored sessions at the YMCA attended by the participant.

    Week 12

Secondary Outcomes (1)

  • Percent participants meeting physical activity goal

    Week 12

Study Arms (2)

A2: Breast Cancer Survivor

EXPERIMENTAL

Participants will include breast cancer survivors who take part in a weight loss intervention program. The intervention is the same for all participants.

Behavioral: Supervised ExerciseBehavioral: Home-based ExerciseBehavioral: Reduced Energy DietBehavioral: Group Phone Calls

B: High Risk Women

EXPERIMENTAL

Participants will include women at high risk of breast cancer who take part in a weight loss intervention program. The intervention is the same for all participants.

Behavioral: Supervised ExerciseBehavioral: Home-based ExerciseBehavioral: Reduced Energy DietBehavioral: Group Phone Calls

Interventions

Supervised ExerciseBEHAVIORAL

Participants will take part in supervised exercise activities two times per week at a YMCA. Length of the activity will be increased during participation in study. Participants will start at 40 minutes per week and work their way up to 120 minutes per week.

A2: Breast Cancer SurvivorB: High Risk Women
Home-based ExerciseBEHAVIORAL

Aerobic exercise activities to be completed at home. Participants will be asked to start out doing 60 minutes at home and work up to 180 minutes of purposeful aerobic home exercise per week.

A2: Breast Cancer SurvivorB: High Risk Women
Reduced Energy DietBEHAVIORAL

Diet is a nutritionally balanced, reduced energy diet recommended by the Academy of Nutrition and Dietetics.

A2: Breast Cancer SurvivorB: High Risk Women
Group Phone CallsBEHAVIORAL

Sessions are weekly months 1-3 and every other week months 4-6. The calls will discuss lifestyle changes specific to participants and cover the effects of diet, physical activity, and weight on breast cancer risk, as well as body image and emotional eating.

A2: Breast Cancer SurvivorB: High Risk Women

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of breast cancer having completed any cytotoxic chemotherapy, radiation or surgery at least 3 months prior to study entry (Cohort A2) OR No prior diagnosis of breast cancer but at high risk for development of breast cancer and participating in HSC 4601 (Cohort B)
  • Body Mass Index (BMI) \>30 kg/m2. Women with a BMI \> 45 kg/m2 must be age \< 60 and ability to perform physical activity must be confirmed
  • By self-assessment, currently performing 60 minutes or less of purposeful exercise per week but able to walk at least 30 minutes on a level surface
  • Possession of smart phone capable of running MyFitnessPal and Garmin Connect apps and willing to have diet and exercise data accessed by study personnel
  • Access to a personal computer
  • Live in the greater Kansas City Metropolitan Area
  • Willing and able to perform moderate intensity exercise at least 5 days per week for 6 months. This consists of a supervised exercise intervention at one of the 15 YMCAs affiliated with our program for 2 days per week. Must be willing to perform unsupervised home exercise for the entire 6 months.
  • Willing to participate in a weekly behavioral modification group phone call for first 3 months and every 2 weeks for the second 3 months
  • Willing to participate in a controlled dietary intervention with portion controlled meals and partial meal replacements plus 35 servings of fruits and vegetables/week for 6 months and track food intake and exercise
  • Blood tests (Cohort A2) must have been performed after completion of any breast cancer surgery, radiation therapy, or cytotoxic chemotherapy, with reasonably normal liver and renal function as well as a hemoglobin of 10 or higher and/or performed within a year of study entry

You may not qualify if:

  • Use of metformin, insulin, steroids or prescription weight loss or anti-psychotic drugs within the prior 3 weeks
  • Individuals with prior gastric bypass surgery or procedure that would impair absorption of nutrients
  • Need for chronic immunosuppressive drugs
  • Participation within the past 6 months on a structured weight loss program such as Weight Watchers®
  • Physical impairments (bad hip, knees, feet, peripheral neuropathy) that would prohibit performing moderate intensity exercise at least 5 days per week.
  • Any other condition or intercurrent illness that in the opinion of the investigator makes the subject a poor candidate for participation in the trial such as recent cardiac event
  • Currently receiving investigational agents in a clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (1)

  • Fabian CJ, Klemp JR, Marchello NJ, Vidoni ED, Sullivan DK, Nydegger JL, Phillips TA, Kreutzjans AL, Hendry B, Befort CA, Nye L, Powers KR, Hursting SD, Giles ED, Hamilton-Reeves JM, Li B, Kimler BF. Rapid Escalation of High-Volume Exercise during Caloric Restriction; Change in Visceral Adipose Tissue and Adipocytokines in Obese Sedentary Breast Cancer Survivors. Cancers (Basel). 2021 Sep 28;13(19):4871. doi: 10.3390/cancers13194871.

    PMID: 34638355RESULT

Study Officials

  • Carol Fabian, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Director Breast Cancer Prevention Unit

Study Record Dates

First Submitted

August 30, 2017

First Posted

September 1, 2017

Study Start

September 25, 2017

Primary Completion

July 24, 2018

Study Completion

July 24, 2018

Last Updated

December 18, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)