Clinical trial NCT06395506: THRIVE Well Cancer FDTN/Exercise_Creatine Supplementation
Official title: An Open-label Randomized Trial of Exercise ± Creatine Supplementation to Augment the Adaptations of Exercise Training in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Breast Cancer Female
Muscle Weakness
Keywords: Breast Cancer
Breast Cancer Female
Exercise
Creatine Supplement
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: ThriveWell Cancer Foundation
First posted: 2024-05-02
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Change in strength in breast cancer survivors
timeFrame: baseline and 12 weeks
measure: Change in physical functional capacity in breast cancer survivors
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: Change intramuscular storage of creatine
timeFrame: baseline and 12 weeks
measure: Change in body composition in cancer survivors
timeFrame: baseline and 12 weeks
measure: Change in the return of strength for breast cancer survivors with creatine + exercise
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Galveston
country: United States
facility: The University of Texas Medical Branch, Galveston
state: Texas
Study officials:
affiliation: University of Texas
name: Darpan Patel, PhD
role: PRINCIPAL_INVESTIGATOR
References: