Breast Cancer, Breast Cancer Female, Muscle Weakness
Conditions
Keywords
Breast Cancer, Breast Cancer Female, Exercise, Creatine Supplement
Brief summary
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.
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 objective is to determine the effects of creatine in modulating strength and physical function in 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 Medical Branch, Galveston
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. 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
Yes
Inclusion criteria
(Breast Cancer Group) * 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 * 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
(Breast Cancer Group) * 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 greater than 2+ * Currently undergoing chemotherapy treatment for cancer * 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 become pregnant during the study * Recent (within one month) or anticipated treatment with corticosteroids (except for short term use during the time of chemotherapy), 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 * Lack of availability to a smartphone and/or internet Inclusion Criteria (Healthy Age-matched Control Group) * Age 18-75 years of age * Have never been diagnosed with cancer * Willing to provide consent to participate in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in strength in breast cancer survivors | baseline and 12 weeks | Determine the change in strength in breast cancer survivors by comparing pre and post measurements of strength measurement tools including 1RM/10RM/Biodex evaluations. |
| Change in physical functional capacity in breast cancer survivors | baseline and 12 weeks | Determine the change in strength in breast cancer survivors by comparing pre and post measurements of the six minute walk test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change intramuscular storage of creatine | baseline and 12 weeks | Determine the change in intramuscular storage of creatine by comparing pre and post vastus lateralis muscle using MRI. |
| Change in body composition in cancer survivors | baseline and 12 weeks | 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. |
| Change in the return of strength for breast cancer survivors with creatine + exercise | 12 weeks | 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. |
Countries
United States
Contacts
Primary ContactLisa Thibodeaux, RN,BSN
Backup ContactRebecca Geck, MPH,APRN,CPT
Outcome results
None listed