THRIVE Well Cancer FDTN/Exercise_Creatine Supplementation

NCT06395506 | Recruiting DMC

• 1 other identifier: 23-0215
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Breast Cancer Female; Muscle Weakness

Keywords

Breast Cancer; Breast Cancer Female; Exercise; Creatine Supplement

Outcome Measures

Primary Outcomes (2)

• Change in strength in breast cancer survivors

  Determine the change in strength in breast cancer survivors by comparing pre and post measurements of strength measurement tools including 1RM/10RM/Biodex evaluations.

  baseline and 12 weeks

• Change in physical functional capacity in breast cancer survivors

  Determine the change in strength in breast cancer survivors by comparing pre and post measurements of the six minute walk test.

  baseline and 12 weeks

Secondary Outcomes (3)

• Change intramuscular storage of creatine

  baseline and 12 weeks

• Change in body composition in cancer survivors

  baseline and 12 weeks

• Change in the return of strength for breast cancer survivors with creatine + exercise

  12 weeks

Study Arms (3)

Age-Matched Control Group

NO INTERVENTION

Women who have never been diagnosed with cancer.

Creatine Supplement Group

EXPERIMENTAL

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.

Dietary Supplement: Creatine

Non-Creatine Supplement Group

NO INTERVENTION

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.

Interventions

Creatine DIETARY_SUPPLEMENT

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.

Creatine Supplement Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Age 18-75 years of age
• Have never been diagnosed with cancer
• Willing to provide consent to participate in this study

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• ThriveWell Cancer Foundation: collaborator

Study Sites (1)

The University of Texas Medical Branch, Galveston

Galveston, Texas, 77555, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Muscle Weakness; Motor Activity

Interventions

Creatine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Darpan Patel, PhD

  University of Texas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Thibodeaux, RN,BSN

CONTACT

4094741756; lbthibod@utmb.edu

Rebecca Geck, MPH,APRN,CPT

CONTACT

4092660496; raschaef@utmb.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: May 2, 2024
• Study Start: October 29, 2024
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)