Purpose

The purpose of this study is to test the hypothesis that creatine will accelerate adaptations associated with exercise in breast cancer survivors recently completing chemotherapy.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 60 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age 18-60 years of age
  • Recent (within 6 months) completion of chemotherapy
  • Willing to attend 3 clinic based exercise sessions per week
  • Able to take oral medications
  • Participant is willing and able to provide consent to participating in the study
  • Serum creatinine ≤ 1.5 x ULN or Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equation.

Exclusion Criteria

  • 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
  • Pitting edema
  • Currently undergoing medical treatment for cancer (i.e. currently undergoing hormone therapy, chemotherapy or radiation therapy).
  • History of moderate-severe heart disease (New York Heart Classification greater than grade II) or pulmonary disease (dyspnea on exertion upon climbing one flight of stairs or less; abnormal breath sounds on auscultation).
  • Pregnant or plan to get pregnant during the study
  • Recent (within one month) or anticipated treatment with corticosteroids (except for short term use during the time of chemotherapy), androgens, progestational agents, or other appetite stimulants
  • Serum creatinine > 1.5 x ULN or Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equation.
  • Currently taking creatine supplements

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This study plans to enroll 30 breast cancer patients who have completed chemotherapy within 6 months prior to consenting for this study. Patients eligible to participate in this study will be allocated to either the creatine group or the control group (1:1) based on a pre-determined randomization list. Each arm will have 15 participants. One arm will receive creatine and the other will serve as the control group with no creatine.
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Dietary Supplement: Creatine
    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.
No Intervention
Exercise Only Control Group
Participants will not participate in the creatine intervention (creatine supplementation). Participants will engage in three center-based exercise sessions each week for 12 weeks; each session lasting roughly 1-hour. Exercise sessions will be held by trained study staff held at the Medical Arts and Research Center Physical Therapy clinic (address listed above).

Recruiting Locations

UT Health San Antonio
San Antonio, Texas 78229
Contact:
Darpan Patel, PhD
210-567-0362
pateld7@uthscsa.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center at San Antonio

Study Contact

Amber M Gallegos, BS
(210)606-2437
gallegosa4@uthscsa.edu

Detailed Description

The primary objective of this study is to determine the effects of creatine supplementation in modulating strength and physical function in breast cancer survivors that have recently completed chemotherapy. The primary hypothesis for this objective is that creatine will lead to significantly greater gains in strength and physical function in breast cancer survivors compared to exercise alone. The secondary objective is to determine if supplemental creatine can increase intramuscular storage of creatine and alter energy storage. The hypothesis for this objective is that creatine supplementation will significantly increase intramuscular concentrations of creatine (Cr), phosphocreatine (PCr) and adenosine triphosphate (ATP) in the vastus lateralis (VL) compared to controls. The secondary hypothesis for this objective is that the creatine group will have significantly greater muscle cross-sectional area and significantly lower intramuscular fat compared to controls. The final objective for this study is to test the hypothesis that creatine supplementation will improve body composition in breast cancer survivors.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.