Breast Cancer, Chemotherapy Effect, Exercise, Muscle Loss, Muscle Weakness
Conditions
Keywords
Special Populations, Exercise Oncology, Creatine Supplementation, Magnetic Resonance Spectroscopy
Brief summary
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.
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.
Interventions
DIETARY_SUPPLEMENTCreatine
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.
Sponsors
ThriveWell Cancer Foundation
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-75 years of age * Recent (within 6 months) completion of chemotherapy * Willing to attend 3 virtual 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 chemotherapy * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in strength in breast cancer survivors | From baseline to 12 weeks | Participants will be evaluated for knee extensor strength via isometric maximum voluntary contraction at approximately 60° knee flexion. |
| Change in functional capacity in breast cancer survivors | From baseline to 12 weeks | Functional exercise capacity will be assessed via the 6 minute walk test (6MWT). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in intramuscular creatine and altering energy storage. | From baseline to 12 weeks | Muscle Creatine, Phosphocreatine, and Adenosine-triphosphate content will be assessed in vivo by 31P-MRS using a whole body 3.0T MRI scanner. |
| Change in muscle cross sectional area | From baseline to 12 weeks | Magnetic resonance imaging will be used to capture the mid-thigh cross section. |
Countries
United States
Outcome results
None listed