THRIVE Well Cancer FDTN/Exercise_Creatine Supplementation

Part of paid clinical trials in Galveston, Texas.

Sponsor
The University of Texas Medical Branch, Galveston
Study ID
NCT06395506
Status
Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Creatine — DIETARY_SUPPLEMENT
    Those randomized to receive creatine (experimental group) will be initially dosed at 20 g/day for 7 days to boost availability of creatine systemically. Thereafter, the dose will be reduced to 5 g/day for maintenance through the duration of the 12-week protocol.

Study Details

The study's purpose is to evaluate whether creatine supplementation can help breast cancer survivors respond quicker to exercise by improving strength, endurance, and body composition. We are seeking to compare information collected from healthy woman of the same age who have never had breast cancer to those participants who have had breast cancer and undergone chemotherapy treatment.

Key Dates

Start date
Oct 29, 2024
Status verified
Dec 2025
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: Age-Matched Control Group
    Women who have never been diagnosed with cancer.
  • Experimental: Creatine Supplement Group
    Those randomized to receive creatine (experimental group) will be initially dosed at 20 g/day for 7 days to boost availability of creatine systemically. Thereafter, the dose will be reduced to 5 g/day for maintenance through the duration of the 12-week protocol. Participants will engage in three center-based exercise sessions each week for 12 weeks; each session lasting roughly 1-hour. Participants will be given a fitbit (electronic watch that measures steps or heart rate) as well to track heart rate and monitor activity throughout the study.
  • No Intervention: Non-Creatine Supplement Group
    Participants will engage in three center-based exercise sessions each week for 12 weeks; each session lasting roughly 1-hour. Participants will be given a Fitbit (electronic watch that measures steps or heart rate) as well to track heart rate and monitor activity throughout the study.

Primary Outcome Measure

Change in strength in breast cancer survivors [ Time Frame: baseline and 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Medical Branch, GalvestonGalvestonTexas77555
Lisa Thibodeaux, RN,BSN
409-474-1756
Rebecca Geck, MPH,APRN,CPT
4092660496

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