THRIVE Well Cancer FDTN/Exercise_Creatine Supplementation

Trial Title: THRIVE Well Cancer FDTN/Exercise_Creatine Supplementation

NCT ID: NCT06395506

Condition: Breast Cancer
Breast Cancer Female
Muscle Weakness

Conditions: Official terms:
Breast Neoplasms
Muscle Weakness

Conditions: Keywords:
Breast Cancer
Breast Cancer Female
Exercise
Creatine Supplement

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

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. 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)

Intervention:

Intervention type: Dietary Supplement
Intervention name: Creatine
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.
Arm group label: Creatine Supplement Group

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.

Criteria for 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

Gender: Female

Gender based: Yes

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: The University of Texas Medical Branch, Galveston

Address:
City: Galveston
Zip: 77555
Country: United States

Status: Recruiting

Contact:
Last name: Lisa Thibodeaux, RN,BSN

Phone: 409-474-1756
Email: lbthibod@utmb.edu

Contact backup:
Last name: Rebecca Geck, MPH,APRN,CPT

Phone: 4092660496
Email: raschaef@utmb.edu

Start date: October 29, 2024

Completion date: May 31, 2028

Lead sponsor:
Agency: The University of Texas Medical Branch, Galveston
Agency class: Other

Collaborator:
Agency: ThriveWell Cancer Foundation
Agency class: Other

Source: The University of Texas Medical Branch, Galveston

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06395506