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A Pilot Study Assessing Myokines During an EXErcise Regimen After Treatment for Breast Cancer (Myo-EXERTBC)

Myo-EXERTBC: A Pilot Study Assessing Myokines During an EXErcise Regimen After Treatment for Breast Cancer

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

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

21

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Clinical Trials Contact
  • Telefonnummer: 412-330-6151
  • E-mail: ctgov@ahn.org

Studiesteder

    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15212
        • AHN Allegheny General Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Age 20-89 years
  2. Women prescribed exercise as a SOC
  3. Women with a biopsy proven diagnosis of ductal carcinoma in situ (DCIS) or invasive carcinoma of the breast
  4. 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.
  5. Women with > 3 months of resistance training experience under expert guidance at the Allegheny Health Network Exercise Oncology Center

Exclusion Criteria:

  1. Any current treatment with cytotoxic chemotherapy for breast cancer
  2. Inability to safely engage in group sessions of resistance training as deemed by study PI
  3. Severe arthritic, joint, cardiovascular, or musculoskeletal condition deemed by PI to be unsafe to engage in resistance training
  4. Pregnant women
  5. Males

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Conditioning Regimen Group
Participants in this group will perform a conditioning regimen from the EXERT-BCHC protocol, specifically described as "double training".
Eksperimentel: Strength Regimen Group
Participants in this group will perform a strength regimen from the EXERT-BCHC protocol, specifically described as "8x8".
Eksperimentel: Hypertrophy Regimen Group
Participants in this group will perform a hypertrophy regimen from the EXERT-BCHC protocol, specifically described as the "control arm".

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Myokine Production After First Exercise Session
Tidsramme: Immediately before and immediately after the 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.
Immediately before and immediately after the first exercise session.
Change in Myokine Production After Final Exercise Session of Each Week
Tidsramme: Immediately before and immediately after the final exercise session of weeks 1, 2, 3, and 4.
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.
Immediately before and immediately after the final exercise session of weeks 1, 2, 3, and 4.
Change in Myokine Production After Final Exercise Session of the Month (End of Study)
Tidsramme: Immediately before and immediately after the final exercise session of week 4 (end of the 4-week exercise regimen).
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.
Immediately before and immediately after the final exercise session of week 4 (end of the 4-week exercise regimen).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Colin Champ, MD, AHN Radiation Oncology

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. juni 2028

Datoer for studieregistrering

Først indsendt

7. juli 2026

Først indsendt, der opfyldte QC-kriterier

7. juli 2026

Først opslået (Faktiske)

13. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Conditioning Resistance Training

Abonner