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Trial record 36 of 55 for:    cancer AND energy restriction

Effects of Diet and Exercise on Ductal Carcinoma in Situ (DCIS)

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ClinicalTrials.gov Identifier: NCT02224807
Recruitment Status : Completed
First Posted : August 25, 2014
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Wendy Demark-Wahnefried, PhD, University of Alabama at Birmingham

Brief Summary:
This pilot/feasibility trial seeks to explore whether an acute bout of negative energy balance prior to surgery affects biomarkers of neoplasia. Forty overweight or obese postmenopausal women diagnosed with ductal carcinoma in situ (DCIS) or early stage breast cancer (Stage I or II) who elect mastectomy or lumpectomy will be randomly assigned to 1-of-2 study arms: 1) an Attention Control Group that receives instruction on dietary approaches to correct nutritional deficiencies and progressive resistance training (PRT) that targets the arm ipsilateral to the affected breast; or 2) an Experimental Group that will receive PRT and guidance to correct nutritional deficiencies plus an intensive intervention to promote a 1.5-2 pound/week weight loss through diet, exercise, and behavior modification. This study will explore and contrast changes in body mass index (BMI) observed from enrollment to the time of surgery in the experimental vs. attention control arms, and also monitor changes in energy intake and physical activity. These changes will be studied in relation to the following endpoints: a) changes in select circulating biomarkers and gene expression related to cancer progression, hormonal status, inflammation and other energy-related factors; b) rates of tumor proliferation and apoptosis; c) tumor markers, e.g., insulin receptor, Vascular Epithelial Growth Factor (VEGF), Nuclear Factor kappa beta (NFkB), and phosphoproteins associated with the Convergence of Hormones, Inflammation and Energy-Rated Factors (CHIEF) pathway; and d) functional and health-related outcomes. Because both tumor tissue and blood will be examined from pre-to-post-intervention, this study will provide exciting new data that can elucidate pathways by which energy balance affects breast cancer progression. Although longer term weight loss is recommended for overweight and obese breast cancer survivors, it is not known whether placing the body in a state of negative energy balance will have a favorable impact on the tumor. If beneficial changes in tumor biology and the host environment occur with short-term, pre-surgical weight loss, this study provides proof of concept that weight loss may offer an acceptable and complementary treatment option that could be combined with standard therapies.

Condition or disease Intervention/treatment Phase
Ductal Carcinoma In Situ Breast Cancer Behavioral: Active Comparator: Progressive Resistance Training (PRT) and a healthy diet Behavioral: Experimental: PRT and a healthy diet, plus weight loss Not Applicable

Detailed Description:
Obesity is a known risk factor for invasive breast cancers that occur post-menopause. Obese women also die twice as frequently from breast cancer than those of normal weight. Numerous preclinical studies show the benefits of caloric restriction on cancer progression in animals - but, will similar effects be seen in humans? In response to a call for translational studies that will identify biological/biobehavioral pathways through which weight loss may affect cancer prognosis (PAR-12-229), the investigators propose a pilot study that builds on the investigators success of pre-surgical interventions to answer the research question, "does negative energy balance with concomitant weight loss invoke anti-cancer effects on tumor biology and the host environment?" The investigators will randomly assign 40 overweight or obese postmenopausal women diagnosed with ductal carcinoma in situ (DCIS) or early stage breast cancer who elect mastectomy or lumpectomy to 1-of-2 study arms: 1) an Attention Control Group that receives instruction on dietary approaches to correct nutritional deficiencies and progressive resistance training (PRT) that targets the arm ipsilateral to the affected breast; or 2) an Experimental Group that will receive PRT and guidance to correct nutritional deficiencies plus an intensive intervention to promote a 1.5-2 pound/week weight loss through diet, exercise, and behavior modification. This study will explore and contrast changes in body mass index (BMI) observed from enrollment to the time of surgery in the experimental vs. attention control arms, and also monitor changes in energy intake and physical activity. These changes will be studied in relation to the following endpoints: a) changes in select circulating biomarkers and gene expression related to cancer progression, hormonal status, inflammation and other energy-related factors; b) rates of tumor proliferation and apoptosis; c) tumor markers, e.g., insulin receptor, Vascular Epithelial Growth Factor (VEGF), Nuclear Factor kappa beta (NFkB), and phosphoproteins associated with the Convergence of Hormones, Inflammation and Energy-Rated Factors (CHIEF) pathway; and d) functional and health-related outcomes. Because both tumor tissue and blood will be examined from pre-to-post-intervention, this study will provide exciting new data that can elucidate pathways by which energy balance affects breast cancer progression from a non-invasive to an invasive state. Although longer term weight loss is recommended for overweight and obese breast cancer survivors, it is not known whether placing the body in a state of negative energy balance will have a favorable impact on the tumor. If beneficial changes in tumor biology and the host environment occur with short-term, pre-surgical weight loss, this study provides proof of concept that weight loss may offer an acceptable and complementary treatment option that could be combined with standard therapies. Thus, the research that is proposed will not only increase the investigators understanding of the impact of negative energy balance on tumor biology, but could change the standard of care and offer a more conservative treatment option for the 50,000 American women who are diagnosed with DCIS each year, as well as a novel adjunct therapy for women with early stage invasive disease.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Exploring Effects of Weight Loss on Ductal Carcinoma In Situ
Study Start Date : July 2014
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Progressive Resistance Training (PRT) and a healthy diet
PRT will be done with resistance bands; participants will receive instruction on three resistance band exercises (triceps, biceps, and shoulder overhead) from an American College of Sports Medicine (ACSM) certified exercise specialist. Participants also will receive dietary counseling from a registered dietitian on correcting nutrient deficiencies that are detected during analysis of their 2-day dietary recalls.
Behavioral: Active Comparator: Progressive Resistance Training (PRT) and a healthy diet
no additional information; see arm description
Other Name: Diet; Exercise; Physical activity

Experimental: PRT and a healthy diet, plus weight loss
This arm will receive all components of the active comparator arm, plus counseling to achieve a weight loss of 1.5-2 pounds/week. Participants will be trained on how to achieve this caloric deficit through both dietary restriction and increased physical activity. Weight loss will be promoted via a healthy, nutritionally adequate diet consistent with American Cancer Society guidelines. Protein levels will be based on 0.8 g/kg body weight. The distribution of food groups will be customized for preferences. An exercise program will be tailored taking into account kcal expenditure for various activities at a specific body weight; expenditures of 200-400 kcal/day will serve as a goal. Aerobic training of large muscles (legs) will be emphasized to achieve a greater kcal deficit; ramping of intensity and volume over time will be pursued as per the ACSM guidelines. Participants will train once weekly while supervised by an exercise physiologist and daily at home.
Behavioral: Experimental: PRT and a healthy diet, plus weight loss
no additional information, see arm description
Other Name: Diet; Exercise, Physical Activity




Primary Outcome Measures :
  1. Tumor proliferation [ Time Frame: Baseline to Time of Surgery ]
    Ki-67 will be used to determine tumor proliferation. Ki-67 is a cancer antigen that is found in growing, dividing cells but is absent in the resting phase of cell growth. This characteristic makes Ki-67 a good tumor marker. This test is done on a sample of tumor tissue, to help predict prognosis. High levels of Ki-67 indicate an aggressive tumor and predict a poor prognosis. High scores mean that the cancer cells are growing and dividing at a rapid pace. The Ki-67 scores will be compared between arms.

  2. Weight [ Time Frame: Baseline to Time of Surgery ]
  3. Feasibility [ Time Frame: Baseline to Time of Surgery ]
    Enroll 40 subjects within 2-year study, retain >80% of the sample and completion >70% of contact sessions.


Secondary Outcome Measures :
  1. Body Composition [ Time Frame: Baseline to Time of Surgery ]
    Via Dual Energy Absorptiometry (DXA)

  2. Waist Circumference [ Time Frame: Baseline to Time of Surgery ]
  3. Tumor markers [ Time Frame: Baseline to Time of Surgery ]
    Tumor Markers on the CHIEF (Convergence of Hormonal, Inflammatory and Energy-related Factors) Pathway, e.g., Insulin Receptor, Vascular Endothelial Growth Factor (VEGF), Tumor Necrosis Factor alpha (TNF-alpha), Nuclear Factor Kappa Beta (NFKB), caspase-3, as well as various phosphoproteins.

  4. Serum Biomarkers [ Time Frame: Baseline to Time of Surgery ]
    Insulin, leptin, Sex Hormone Binding Globulin, VEGF, TNF-alpha

  5. Gene expression [ Time Frame: Baseline to Time of Surgery ]
    Select genes on the CHIEF pathway as well as ~47,231 curated and putative genes and expressed sequence tags (ESTs)

  6. Dietary Intake [ Time Frame: Baseline to Time of Surgery ]
    24-hour recalls to assess kcal intake as well as intake of fat, protein, and carbohydrate and diet quality

  7. Physical Activity [ Time Frame: Baseline to Time of Surgery ]
    Assessed via accelerometry as well as via questionnaire

  8. Quality of Life [ Time Frame: Baseline to Time of Surgery ]
    Using the FACT-B

  9. Cardiorespiratory Fitness [ Time Frame: Baseline to Time of Surgery ]
    Sub-maximal testing and a modified version of the Naughton Protocol



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postmenopausal women with intermediate-to-high nuclear grade DCIS or stage I or II breast cancer who elect surgery and who have >3-week lag-time between the start of the intervention and their scheduled surgery;
  • Overweight or obese (BMI:25-60);
  • English speaking/reading
  • Willing to be assigned to either study arm

Exclusion Criteria:

  • Have a pre-existing medical condition(s) that preclude adherence to unsupervised exercise;
  • Have a current medical condition that affects weight status;
  • Has an active malignancy, other than DCIS, invasive breast cancer, or non-melanoma skin cancer;
  • Currently enrolled in a weight loss program
  • Have received or scheduled to receive neoadjuvant chemotherapy prior to mastectomy or lumpectomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02224807


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Wendy Demark-Wahnefried, PhD, RD University of Alabama at Birmingham

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wendy Demark-Wahnefried, PhD, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02224807     History of Changes
Other Study ID Numbers: R21CA178359-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 25, 2014    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

Keywords provided by Wendy Demark-Wahnefried, PhD, University of Alabama at Birmingham:
breast cancer
diet
exercise
weight loss

Additional relevant MeSH terms:
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Carcinoma
Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Breast Carcinoma In Situ