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

NCT00405678 | Completed Phase 1

• 2 other identifiers: Pro000071128426
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

Exercise Intervention; Breast Cancer; Neo-Adjuvant Therapy; Operable Breast Cancer Stage I-II receiving neo-adjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

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

  3 months

Secondary Outcomes (4)

• Adherence to fitness program

  3 months

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

  3 months

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

  3 months

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

  3 months

Study Arms (2)

1

EXPERIMENTAL

Subjects receiving chemo and exercise training

Behavioral: Exercise Training

2

EXPERIMENTAL

Subjects receiving chemo only

Behavioral: Exercise Training; Behavioral: Chemo only

Interventions

Exercise Training BEHAVIORAL

Subjects receiving chemo with exercise training

1; 2

Chemo only BEHAVIORAL

Subjects receiving chemo only

2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• Duke University: lead
• United States Department of Defense: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (78)

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MeSH Terms

Conditions

Breast Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lee W Jones, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2006
• First Posted: November 30, 2006
• Study Start: September 1, 2006
• Primary Completion: February 1, 2010
• Study Completion: September 1, 2010
• Last Updated: July 11, 2014

Record last verified: 2013-07

Locations

US (1)