Health TrialsbyHealthPanel

THRIVE Well Cancer FDTN/Exercise_Creatine Supplementation

ConditionsBreast CancerBreast Cancer FemaleMuscle Weakness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorThe University of Texas Medical Branch, Galveston

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18-75 years of age

Diagnosis of breast cancer requiring chemotherapy

Recent (within 6 months) completion of chemotherapy

Willing to attend 3 virtual-based exercise sessions per week

Disqualifiers

Physical indications where performing exercise may be limited and/or contraindicated

Poorly controlled hypertension (blood pressure > 160/95mmHg)

Current tobacco use (within 6 months)

Anabolic steroids use

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Age-Matched Control GroupNo intervention 0 interventions
Group B: Creatine Supplement GroupExperimental treatment 1 intervention
Group C: Non-Creatine Supplement GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in strength in breast cancer survivors

Determine the change in strength in breast cancer survivors by comparing pre and post measurements of strength measurement tools including 1RM/10RM/Biodex evaluations.

Time frame
baseline and 12 weeks
2

Change in physical functional capacity in breast cancer survivors

Determine the change in strength in breast cancer survivors by comparing pre and post measurements of the six minute walk test.

Time frame
baseline and 12 weeks

Secondary outcomes

1

Change intramuscular storage of creatine

Determine the change in intramuscular storage of creatine by comparing pre and post vastus lateralis muscle using MRI.

Time frame
baseline and 12 weeks
2

Change in body composition in cancer survivors

Determine the change in body composition in breast cancer survivors by pre and post measurements of bone mass as well as lean vs fat mass via a DEXA scan.

Time frame
baseline and 12 weeks
3

Change in the return of strength for breast cancer survivors with creatine + exercise

Breast cancer survivors who complete 12-weeks of exercise with creatine supplementation group who regained strength and physical function to that of women of similar age who never had cancer.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

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

The University of Texas Medical Branch, Galveston

Lead sponsor

ThriveWell Cancer Foundation

Collaborator

Source ClinicalTrials.gov
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