THRIVE Well Cancer FDTN/Exercise_Creatine Supplementation

The University of Texas System (UT)

Status: Enrolling

Conditions: Breast Cancer; Breast Cancer Female; Muscle Weakness

Treatments: Dietary Supplement: Creatine

Study type: Interventional

Funder types: Other

Identifiers

NCT06395506

23-0215

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Exclusion Criteria (Healthy Age-matched Control 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+
• History of cancer diagnosis
• 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 currently taking prescribed medication to prepare for pregnancy (i.e.

hormonal therapy for IVF)

• Recent (within one month) treatment with corticosteroids
• Recent (within one month) use of appetite stimulants or appetite suppressants
• 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
• Diagnosed Bipolar Disorder or MDQ score indicative of bipolar disorder or Neurological disorders
• Uncontrolled diabetes (A1c of 6.5% or higher)
• Currently taking creatine supplements
• Lack of availability to a smartphone and/or internet

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Age-Matched Control Group

No Intervention group

Description:

Women who have never been diagnosed with cancer.

Creatine Supplement Group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Creatine

Non-Creatine Supplement Group

No Intervention group

Description:

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.