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Near Infrared Spectroscopy (NIRS) as a Method for Measuring Oxidative Capacity of Skeletal Muscle Mitochondria in Breast Cancer and All Gynecological Cancer Patients

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
20 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions, Questionnaires, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will return for each subsequent visit within a week before their next chemotherapy infusion as long as they are able to safely continue the exercise protocol."
  • "The investigators will also be administering BFI, PROMIS Global Health, and Physical Activity Follow-up surveys after each individual study session to assess changes in cancer related fatigue associated with chemotherapy treatment that may develop throughout the study time period."
  • "Participants will undergo routine, standard of care blood draws for a CBC and metabolic testing per their managing physician with an additional tube, during the same venipuncture, for a study covered aliquot for biomarkers related to mitochondrial health for correlative research."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how chemotherapy affects the parts of muscle cells that use oxygen to make energy. It is for people with breast cancer or cancer of the female reproductive organs that has not spread to distant parts of the body. Participants ride a stationary bike while near-infrared light measures their front thigh muscle without entering the body.

Participants recruited for this study will be breast cancer or gynecological cancer patients who agree to participate in an exercise study examining the effects of chemotherapy on muscle mitochondrial oxidative capacity, a measure of skeletal muscle health. Participants will ride a stationary bicycle and the quadriceps muscle will be non-invasively evaluated.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have breast cancer or cancer of the female reproductive organs that has not spread to distant parts of the body.
  • Can ride a stationary bike at a moderate effort for up to 15 minutes.
  • Have a starting hemoglobin level above 10. Hemoglobin is a protein in blood that carries oxygen.
  • Have ALT and AST liver test levels below 2.5 times the testing center’s upper normal limit.
  • Score at least 14 on the Godin-Shepard physical activity survey. A lower score means you are not active enough for this study.

Who can't join

  • Breast cancer or cancer of the female reproductive organs that has spread to distant parts of the body.
  • Advanced heart or blood vessel disease, or advanced lung disease.
  • A disease that requires oxygen support all the time.
  • 2 centimeters or more of fat under the skin on the front of the thigh.
  • Cannot walk or stand, have a movement disorder, or have a spinal cord injury.
  • Have an autoimmune disorder, in which the immune system attacks the body.
  • Are pregnant or breastfeeding.
  • Score below 24 on the Mini-Mental State Examination, a test of memory and thinking.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Patients diagnosed with breast cancer or gynecological cancer without distance metastasis * Able to perform exercise on a stationary cycle ergometer at moderate intensities for a maximum of 15 minutes * Hemoglobin values greater than 10 at baseline * ALT and AST values less than 2.5X the upper limit of normal by institutional standards * Godin-Shepard Leisure time Physical Activity Questionnaire (GLTEQ) score of 14 or greater will be included. A score of less than 14 is considered insufficiency active/sedentary Exclusion Criteria: * Metastatic breast or gynecological cancer * Clinically advanced cardiovascular disease * Clinically advanced pulmonary disease * Disease requiring continuous oxygen supplementation * Greater than 2 centimeters or more of subcutaneous adipose tissue on the anterior thigh * Inability to walk or stand * Movement disorders * Spinal cord injuries * Autoimmune disorders * Pregnant or breastfeeding * Mini-Mental State Examination (MMSE) \<24

Study sites (1)

SC