Effect of a Goal Setting Intervention on Exercise in Women With Metastatic Breast Cancer: An Exploration of The Lipogenic Pathway

Metastatic Breast Cancer Clinical Trial

Official title:

Effect of a Goal Setting Intervention on Exercise in Women With Metastatic Breast Cancer: An Exploration of The Lipogenic Pathway

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01653366
• Other study ID #: D11282
• Status: Terminated
• Phase: N/A
• First received: July 19, 2012
• Last updated: August 15, 2016
• Start date: December 2012
• Est. completion date: January 2016

Study information

• Verified date: June 2012
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study is a randomized prospective clinical trial of women with metastatic breast cancer. The purpose of the study is to test if an intervention of regular physical activity review and physical activity goal setting will allow the subjects to achieve a moderate increase in physical activity of 6,000 steps per week. The physical activity review will consist of weekly telephone call to inquire about symptoms and to set physical activity goals. The study will also look to see if the goal setting intervention will affect the time to progression, change in BMI, and quality of life. Quality of life will be measured by answers to questionnaires provided to subjects at regular intervals during the course of the study. Finally, the study will examine the impact of physical activity on expression of tumor molecular molecules, insulin levels, and estradiol levels.

Through an intervention of regular physical activity review and goal setting, the investigators hypothesize that a moderate increase in level of physical activity of 6000 steps per week or more can be obtained by patients with metastatic breast cancer who receive a goal setting intervention. The investigators propose that those who are able to achieve and maintain greater than or equal to 22500 steps per week will demonstrate biologic and molecular differences compared to those who are not able to achieve that level of physical activity. The investigators expect that people who are more active will have longer to progression.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Subjects with measurable per Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1 and biopsy-able (as determined by Co-Investigator John Gemery, MD) metastatic carcinoma of the breast.

• Physically able to undertake a moderate physical activity program.

• Greater than 4 weeks from any radiation treatments for metastatic disease.

• standard of care biopsy must occur within 30 days of registration.

• Able to follow directions and fill out questionnaires and physical activity diaries in English.

• Willing to consent to biopsies and be randomly assigned to one of two study arms which may or may not include physical activity goal setting.

• Consents to be contacted via phone or internet (see Appendix K).

• No to all questions on Physical Activity Readiness Questionnaire (see appendix A) or approved by primary oncologist or other care provider provider for participation.

• Hb >10 without transfusion, liver function tests less than 3 times upper limits of normal, normal thyroid-stimulating hormone (TSH), absolute neutrophil count (ANC) >1500.

• Karnofsky performance status = 80%

• Previous Physical Therapy consultation and treatments acceptable.

• Participation in other trials acceptable.

• CNS disease that is treated and stable by MRI for at least 6 months

Exclusion Criteria:

• Patients less than 18 years of age.

• Patients unable to give informed consent indicating they are aware of the investigational nature of this treatment, prior to entry into the study.

• Pregnant or nursing women.

• Patients with any untreated (CNS) disease.

• Patients with other active cancers requiring treatment.

• Patients with clotting or bleeding disorder precluding biopsy.

• Patients with significant cardiovascular disease, including uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the previous 6 months or serious cardiac arrhythmias will be excluded.

• Current use of supplements containing conjugated linoleic acid, or use within the 30 days preceding registration.

• Persons with a known diagnosis of diabetes are not eligible. Prior use of metformin allowable if previously enrolled on MA.32 trial as part of their adjuvant therapy for early stage breast cancer.

• Persons of male gender.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Behavioral:
• Physical Activity Goal Setting
Will include an initial physical therapy (PTA) consult to set exercise goals to increase physical activity by 6000 steps per week over the course of the trial, viewing of the "Exercise and Breast Cancer" digital video disc (DVD, followed by 10 regular phone calls or RN visits (weekly for the first month, then monthly) to follow up on whether or not those goals are being met and, if not, how best to meet them.

Locations

Country	Name	City	State
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in physical activity as a result of a goal setting intervention using pedometer data and exercise logs.	To increase physical activity levels by at least 6000 steps/wk over 6 months using a goal setting intervention	Baseline, 2 month, 3 month, 4 month, 5 month, 6 months	No
Secondary	Secondary objectives: Time to progression	goal-setting intervention versus standard of care: Time to progression	baseline, 6 months	No
Secondary	Change in Body Mass Index (BMI)		Baseline, 2 month, 3 month, 4 month, 5 month, 6 months	No
Secondary	Health related quality of life	As measured by questionnaires: FACIT-F and diet survey	baseline, 6 months	No
Secondary	Correlative Science outcomes in peripheral blood	serum estradiol and fasting insulin levels	baseline, 6 months	No
Secondary	Correlative science outcomes in tissue biopsies	relative protein expression of Lipoprotein Lipase (LPL), Cluster of Differentiation 36 (CD36), Spot 14 and fatty acid synthase (FASN) of the original tumor to the metastatic tumor at baseline and at the end of the study.	baseline, 6 months	No
Secondary	correlative science in >= 22500 steps	Compare correlative science outcomes in those who achieve greater than or equal to 22500 steps/ week to those who do not.	baseline, 6 months	No
Secondary	participants who achieve >= 22500 steps/week	Determine the proportion of participants who are able to achieve greater than or equal to 22,500 steps/week	6 months	No