Health TrialsbyHealthPanel

A Pilot Study Assessing Myokines During an EXErcise Regimen After Treatment for Breast Cancer

ConditionsCancerBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-89
SponsorAllegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

About this trial

In this pilot study, the investigators will assess the changes in myokine production based on several different exercise regimens.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 20-89 years

Women prescribed exercise as a SOC

Women with a biopsy proven diagnosis of ductal carcinoma in situ (DCIS) or invasive carcinoma of the breast

Women must have undergone treatment for breast cancer, including one or more of the following: surgery, radiation therapy, chemotherapy, immunotherapy, or hormonal therapy. Women undergoing active chemotherapy are not allowed on study. Immunotherapy or targeted agent usage is allowed.

Disqualifiers

Any current treatment with cytotoxic chemotherapy for breast cancer

Inability to safely engage in group sessions of resistance training as deemed by study PI

Severe arthritic, joint, cardiovascular, or musculoskeletal condition deemed by PI to be unsafe to engage in resistance training

Pregnant women

Trial design

Design model

Parallel

Treatments tested in this trial

  • Conditioning Resistance Training

    Behavioral

    Participants in this group will perform a conditioning regimen from the EXERT-BCHC protocol, specifically described as "double training".

  • Strength Resistance Training

    Behavioral

    Participants in this group will perform a strength regimen from the EXERT-BCHC protocol, specifically described as "8x8".

  • Hypertrophy Resistance Training

    Behavioral

    Participants in this group will perform a hypertrophy regimen from the EXERT-BCHC protocol, specifically described as the "control arm".

Treatment groups

21 Participants
are divided into 3 treatment groups
Group A: Conditioning Regimen GroupExperimental treatment 1 intervention
Group B: Strength Regimen GroupExperimental treatment 1 intervention
Group C: Hypertrophy Regimen GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Myokine Production After First Exercise Session

Quantification of a panel of 15 myokines (IL-5, IL-1ra, LIF, Irisin, SPARC, Decorin, Oncostatin M, Myostatin, Follistatin, Apelin, Fibroblast Growth Factor 21 (FGF21), Cathepsin-B, IL-15, METRNL, Myonectin) in both serum and tear samples. The change from pre-exercise to post-exercise levels will be determined.

Time frame
Immediately before and immediately after the first exercise session.
2

Change in Myokine Production After Final Exercise Session of Each Week

Quantification of a panel of 15 myokines (IL-5, IL-1ra, LIF, Irisin, SPARC, Decorin, Oncostatin M, Myostatin, Follistatin, Apelin, Fibroblast Growth Factor 21 (FGF21), Cathepsin-B, IL-15, METRNL, Myonectin) in both serum and tear samples for each group. The change from pre-exercise to post-exercise levels at the end of each week will be determined.

Time frame
Immediately before and immediately after the final exercise session of weeks 1, 2, 3, and 4.
3

Change in Myokine Production After Final Exercise Session of the Month (End of Study)

Quantification of a panel of 15 myokines (IL-5, IL-1ra, LIF, Irisin, SPARC, Decorin, Oncostatin M, Myostatin, Follistatin, Apelin, Fibroblast Growth Factor 21 (FGF21), Cathepsin-B, IL-15, METRNL, Myonectin) in both serum and tear samples for each group. The change from pre-exercise to post-exercise levels at the culmination of the 4-week exercise period will be determined.

Time frame
Immediately before and immediately after the final exercise session of week 4 (end of the 4-week exercise regimen).

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Lead sponsor

Source ClinicalTrials.gov
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