Breast Tumor Oxygenation During Exercise

• Sponsor: University of California, Irvine (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT02340468
• Collaborator: Beckman Laser Institute University of California Irvine (Other)
• Enrollment: 0
• Location: 1
• Duration (Months): 33.1
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

In the field of cancer treatment, it is generally accepted that the enhancement of oxygen delivery to tumors can augment the effect of anti-cancer therapies. In the case of chemotherapy, this enhancement might lead to a larger amount of a given dose of treatment reaching the tumor and having an effect.

Condition or Disease	Intervention/Treatment	Phase
Breast Tumor	Device: diffuse optical spectroscopy

Detailed Description

While the benefits of exercise on overall health are widely documented, little is known about how exercise affects the progression or treatment of malignant neoplasms. Tumors have a complex vascular network which is likely affected by the global changes in hemodynamics and perfusion that occur during moderate exercise. Increased tumor oxygenation is clinically relevant as it may counteract the hypoxic tumor environment which is known to contribute to resistance to chemo- and radiation therapies, angiogenesis, invasiveness and metastasis, genomic instability, and resistance to cell death.

The researcher can use noninvasive optical imaging technology called diffuse optical spectroscopy to safely and non-invasively quantify the dynamics of blood flow and metabolism in tumors and normal tissue of subjects undergoing supervised cycling exercise. The researcher can determine that exercise will measurably increase tumor oxygenation, and that this effect will be proportional to the intensity and/or duration of the exercise performed.

Study Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Breast Tumor Oxygenation During Exercise
• Study Start Date: Apr 1, 2015
• Anticipated Primary Completion Date: Jan 1, 2018
• Anticipated Study Completion Date: Jan 1, 2018

Outcome Measures

Primary Outcome Measures

1. Measure breast tumor oxygenation [up to 12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Tumor group, female, Greater than 21 years of age but less than 70 years of age, Current diagnosis of breast cancer stage 0 - IV or radiologically suspicious for breast cancer BI-RADS score 4 or 5.

• Control group,Female, Greater than 21 years of age but less than 70 years of age, Not currently diagnosed with breast cancer

Exclusion Criteria:

• Under 21 years of age, Pregnant or breastfeeding, Contraindications for moderate exercise, history of heart, pulmonary, or musculoskeletal disease; physician instructions to restrict physical activity.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beckman Laser Institute Medical Clinic	Irvine	California	United States	92612

Sponsors and Collaborators

• University of California, Irvine
• Beckman Laser Institute University of California Irvine

Investigators

• Principal Investigator: Bruce Tromberg, PhD, Beckman Laser Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Beckman Laser Institute and Medical Center, Bruce Tromberg,Ph.D.,Director, Beckman Laser Institute and Medical Clinic and Professor, Departments of Biomedical Engineering and Surgery, University of California, Irvine
• ClinicalTrials.gov Identifier: NCT02340468
• Other Study ID Numbers: NIH/LAMMP-2014-1505
• First Posted: Jan 16, 2015
• Last Update Posted: Dec 4, 2017
• Last Verified: Nov 1, 2017

• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Dec 4, 2017