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Ductal Carcinoma In SituDCISNCT02224807

Effects of Diet and Exercise on Ductal Carcinoma in Situ

A study testing Active Comparator: Progressive Resistance Training (PRT) and a healthy diet and Experimental: PRT and a healthy diet, plus weight loss in people with Ductal Carcinoma In Situ and Breast Cancer, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 19 years and older, women only
Conditions the study is for
Ductal Carcinoma In Situ, Breast Cancer
What is being tested?
Active Comparator: Progressive Resistance Training (PRT) and a healthy diet and Experimental: PRT and a healthy diet, plus weight loss
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
Jul 2014to Jul 2018
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 19 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

Other trials in United States

About this study

Official title: Exploring Effects of Weight Loss on Ductal Carcinoma In Situ

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.

Read the 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.

Being tested
Active Comparator: Progressive Resistance Training (PRT) and a healthy diet, Experimental: PRT and a healthy diet, plus weight loss
Keywords
breast cancer, diet, exercise, weight loss
Medical subject headings
Carcinoma, Intraductal, Noninfiltrating, Breast Neoplasms, Motor Activity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active Comparator: Progressive Resistance Training (PRT) and a healthy dietBehavioural

    Also called Diet; Exercise; Physical activity

    no additional information; see arm description

  • Experimental: PRT and a healthy diet, plus weight lossBehavioural

    Also called Diet; Exercise, Physical Activity

    no additional information, see arm description

Study groups in NCT02224807
Study groupRoleWhat they receive
Progressive Resistance Training (PRT) and a healthy dietActive comparatorPRT 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.
Receives: Behavioral: Active Comparator: Progressive Resistance Training (PRT) and a healthy diet
PRT and a healthy diet, plus weight lossExperimentalThis 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.
Receives: Behavioral: Experimental: PRT and a healthy diet, plus weight loss

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tumor proliferation

    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.

    Measured: Baseline to Time of Surgery

  2. Weight

    Measured: Baseline to Time of Surgery

  3. Feasibility

    Enroll 40 subjects within 2-year study, retain >80% of the sample and completion >70% of contact sessions.

    Measured: Baseline to Time of Surgery

Secondary outcomes (9)

  1. Body Composition

    Via Dual Energy Absorptiometry (DXA)

    Measured: Baseline to Time of Surgery

  2. Waist Circumference

    Measured: Baseline to Time of Surgery

  3. Tumor markers

    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.

    Measured: Baseline to Time of Surgery

  4. Serum Biomarkers

    Insulin, leptin, Sex Hormone Binding Globulin, VEGF, TNF-alpha

    Measured: Baseline to Time of Surgery

  5. Gene expression

    Select genes on the CHIEF pathway as well as ~47,231 curated and putative genes and expressed sequence tags (ESTs)

    Measured: Baseline to Time of Surgery

  6. Dietary Intake

    24-hour recalls to assess kcal intake as well as intake of fat, protein, and carbohydrate and diet quality

    Measured: Baseline to Time of Surgery

  7. Physical Activity

    Assessed via accelerometry as well as via questionnaire

    Measured: Baseline to Time of Surgery

  8. Quality of Life

    Using the FACT-B

    Measured: Baseline to Time of Surgery

  9. Cardiorespiratory Fitness

    Sub-maximal testing and a modified version of the Naughton Protocol

    Measured: Baseline to Time of Surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionJul 2018
  4. Study completionJul 2018

Resources

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
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02224807
Sponsor's protocol ID
R21CA178359-01A1
Acronym
DCIS
Status last verified
Aug 2018
First submitted
19 Aug 2014
Last updated
31 Aug 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Smith KS, Fruge AD, van der Pol W, Caston NE, Morrow CD, Demark-Wahnefried W, Carson TL. Gut microbial differences in breast and prostate cancer cases from two randomised controlled trials compared to matched cancer-free controls. Benef Microbes. 2021 Jun 15;12(3):239-248. doi: 10.3920/BM2020.0098. Epub 2021 Apr 1.

    PubMed 33789551

  • Fruge AD, Van der Pol W, Rogers LQ, Morrow CD, Tsuruta Y, Demark-Wahnefried W. Fecal Akkermansia muciniphila Is Associated with Body Composition and Microbiota Diversity in Overweight and Obese Women with Breast Cancer Participating in a Presurgical Weight Loss Trial. J Acad Nutr Diet. 2020 Apr;120(4):650-659. doi: 10.1016/j.jand.2018.08.164. Epub 2018 Nov 9.

    PubMed 30420171

  • Tsuruta Y, Rogers LQ, Krontiras H, Grizzle WE, Fruge AD, Oster RA, Umphrey HR, Jones LW, Azrad M, Demark-Wahnefried W. Exploring effects of presurgical weight loss among women with stage 0-II breast cancer: protocol for a randomised controlled feasibility trial. BMJ Open. 2016 Sep 15;6(9):e012320. doi: 10.1136/bmjopen-2016-012320.

    PubMed 27633639

Questions about this trial

What is this clinical trial studying?

A study testing Active Comparator: Progressive Resistance Training (PRT) and a healthy diet and Experimental: PRT and a healthy diet, plus weight loss in people with Ductal Carcinoma In Situ and Breast Cancer, run by University of Alabama at Birmingham 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 31 Aug 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Tumor proliferation (time frame: Baseline to Time of Surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02224807, which also lists 3 linked publications.

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 31 Aug 2018.

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