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Breast CancerPhase 1/2NCT00405678

Exercise Intervention Study for Early-Stage Breast Cancer Patients Receiving Neoadjuvant Therapy.

A Phase 1/2 study testing Exercise Training and Chemo only in people with Breast Cancer, run by Duke University 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

To determine the effects of endurance exercise training on cardiopulmonary fitness in breast cancer patients undergoing neoadjuvant chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Exercise Training and Chemo only
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteUnited States
Study dates
Sep 2006to Sep 2010
Phase
Phase 1/2
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed operable primary breast cancer
  • Age 18 or older
  • Karnofsky performance status greater than 70
  • No previous malignancy
  • Absence of significant cardiac disease (left ventricular ejection fraction greater than or equal to 50%)
  • No hormonal replacement therapy use within the past month
Show all 11Show fewer
  • Not pregnant
  • Ability to read and understand English
  • Signed written informed consent prior to beginning protocol specific procedures
  • Willing to travel to DUMC to exercise three times per week
  • Primary treating oncologist approval

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke University Medical Center

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: The Effects of Exercise Training on Tumor Vascularity and Response to Neoadjuvant Therapy in Operable Breast Cancer: A Phase I-II Study

To determine the effects of endurance exercise training on cardiopulmonary fitness in breast cancer patients undergoing neoadjuvant chemotherapy.

Read the detailed description

Given that this is the first study to explore the potential effects of exercise training on exercise capacity, tumor vascularity and response in women undergoing neoadjuvant chemotherapy for operable breast cancer, prior to the initiation of the full investigation, we will conduct a small vanguard study to ensure we can achieve acceptable exercise adherence rates in the absence of dose-limiting toxicities (DLTs). Specifically, three operable breast cancer patients will be recruited and enrolled as described below and perform exercise training for a minimum of six weeks. If acceptable exercise rates are observed in the absence of severe DLTs during this time, we will proceed with the full investigation (recruitment of additional 20 patients) (see Figure 2). Using a prospective, randomized design, potential participants will be identified and screened for eligibility by an assigned Breast Protocol Nurse (TBD) via medical record review of patients scheduled for their primary neoadjuvant chemotherapy consultation at DCCC

Conditions
Breast Cancer
Being tested
Exercise Training, Chemo only
Keywords
Exercise Intervention, Breast Cancer, Neo-Adjuvant Therapy, Operable Breast Cancer Stage I-II receiving neo-adjuvant chemotherapy
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Exercise TrainingBehavioural

    Subjects receiving chemo with exercise training

  • Chemo onlyBehavioural

    Subjects receiving chemo only

Study groups in NCT00405678
Study groupRoleWhat they receive
1ExperimentalSubjects receiving chemo and exercise training
Receives: Behavioral: Exercise Training
2ExperimentalSubjects receiving chemo only
Receives: Behavioral: Exercise Training; Behavioral: Chemo only

What is being measured

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

  1. Determine effects of endurance exercise training on cardiopulmonary fitness via a stress test

    Measured: 3 months

Secondary outcomes (4)

  1. Adherence to fitness program

    Measured: 3 months

  2. Quality of life as determined by the (Functional Assessment of Cancer Therapy-Breast) FACT-B scale.

    Measured: 3 months

  3. Determine and define feasibility for an adequately powered Phase III study.

    Measured: 3 months

  4. Determine effects of exercise training on tumor vascularity, systemic response and tumor response.

    Measured: 3 months

Timeline

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

  1. First posted30 Nov 2006 (estimated)
  2. Study startSep 2006
  3. Primary completionFeb 2010
  4. Study completionSep 2010

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00405678
Sponsor's protocol ID
Pro00007112
Other IDs
8426
Status last verified
Jul 2013
First submitted
29 Nov 2006
Last updated
11 Jul 2014
Results posted
No

Publications

  • American Cancer Society (2005). Cancer: Facts and Figures. ACS, Atlanta, GA.

  • Cole BF, Gelber RD, Gelber S, Coates AS, Goldhirsch A. Polychemotherapy for early breast cancer: an overview of the randomised clinical trials with quality-adjusted survival analysis. Lancet. 2001 Jul 28;358(9278):277-86. doi: 10.1016/S0140-6736(01)05483-6.

    PubMed 11498214

  • Cutuli B, Fourquet A, Luporsi E, Arnould L, Caron Y, Cremoux Pd, Dilhuydy JM, Fondrinier E, Fourme E, Giard-Lefevre S, Blanc-Onfroy ML, Lemanski C, Mauriac L, Sigal-Zafrani B, Tardivon A, This P, Tunon de Lara C, Kirova Y, Fabre N; Federation of French Cancer Centres (FNCLCC), et le groupe de travail SOR. [Standards, Options and Recommendations for the management of ductal carcinoma in situ of the breast (DCIS): update 2004]. Bull Cancer. 2005 Feb;92(2):155-68. French.

    PubMed 15749645

  • Goldhirsch A, Glick JH, Gelber RD, Coates AS, Senn HJ. Meeting highlights: International Consensus Panel on the Treatment of Primary Breast Cancer. Seventh International Conference on Adjuvant Therapy of Primary Breast Cancer. J Clin Oncol. 2001 Sep 15;19(18):3817-27. doi: 10.1200/JCO.2001.19.18.3817. No abstract available.

    PubMed 11559719

  • Rauschecker H, Clarke M, Gatzemeier W, Recht A. Systemic therapy for treating locoregional recurrence in women with breast cancer. Cochrane Database Syst Rev. 2001;2001(4):CD002195. doi: 10.1002/14651858.CD002195.

    PubMed 11687148

  • Wilcken N, Hornbuckle J, Ghersi D. Chemotherapy alone versus endocrine therapy alone for metastatic breast cancer. Cochrane Database Syst Rev. 2003;2003(2):CD002747. doi: 10.1002/14651858.CD002747.

    PubMed 12804433

  • Curnis F, Sacchi A, Corti A. Improving chemotherapeutic drug penetration in tumors by vascular targeting and barrier alteration. J Clin Invest. 2002 Aug;110(4):475-82. doi: 10.1172/JCI15223.

    PubMed 12189241

  • Sherman-Baust CA, Weeraratna AT, Rangel LB, Pizer ES, Cho KR, Schwartz DR, Shock T, Morin PJ. Remodeling of the extracellular matrix through overexpression of collagen VI contributes to cisplatin resistance in ovarian cancer cells. Cancer Cell. 2003 Apr;3(4):377-86. doi: 10.1016/s1535-6108(03)00058-8.

    PubMed 12726863

  • Tannock IF. Tumor physiology and drug resistance. Cancer Metastasis Rev. 2001;20(1-2):123-32. doi: 10.1023/a:1013125027697.

    PubMed 11831640

  • Tannock IF, Lee CM, Tunggal JK, Cowan DS, Egorin MJ. Limited penetration of anticancer drugs through tumor tissue: a potential cause of resistance of solid tumors to chemotherapy. Clin Cancer Res. 2002 Mar;8(3):878-84.

    PubMed 11895922

  • Au JL, Jang SH, Wientjes MG. Clinical aspects of drug delivery to tumors. J Control Release. 2002 Jan 17;78(1-3):81-95. doi: 10.1016/s0168-3659(01)00488-6.

    PubMed 11772451

  • Izumi Y, Xu L, di Tomaso E, Fukumura D, Jain RK. Tumour biology: herceptin acts as an anti-angiogenic cocktail. Nature. 2002 Mar 21;416(6878):279-80. doi: 10.1038/416279b.

    PubMed 11907566

  • Jain RK. Normalizing tumor vasculature with anti-angiogenic therapy: a new paradigm for combination therapy. Nat Med. 2001 Sep;7(9):987-9. doi: 10.1038/nm0901-987. No abstract available.

    PubMed 11533692

  • Jain RK. Normalization of tumor vasculature: an emerging concept in antiangiogenic therapy. Science. 2005 Jan 7;307(5706):58-62. doi: 10.1126/science.1104819.

    PubMed 15637262

  • Padera TP, Stoll BR, Tooredman JB, Capen D, di Tomaso E, Jain RK. Pathology: cancer cells compress intratumour vessels. Nature. 2004 Feb 19;427(6976):695. doi: 10.1038/427695a.

    PubMed 14973470

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Exercise Training and Chemo only in people with Breast Cancer, run by Duke University 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 11 inclusion and 0 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 11 Jul 2014. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Determine effects of endurance exercise training on cardiopulmonary fitness via a stress test (time frame: 3 months). 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 NCT00405678, which also lists 78 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 11 Jul 2014.

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