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Effects of Creatine Supplementation in Breast Cancer Survivors

Primary Purpose

Breast Cancer, Chemotherapy Effect, Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Creatine
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Special Populations, Exercise Oncology, Creatine Supplementation, Magnetic Resonance Spectroscopy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-75 years of age
  • Recent (within 6 months) completion of chemotherapy
  • Willing to attend 3 virtual 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:

  • 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
  • Currently undergoing chemotherapy
  • 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 get pregnant during the study
  • Recent (within one month) or anticipated treatment with corticosteroids (except for short term use during the time of chemotherapy), androgens, progestational agents, 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

Sites / Locations

  • UT Health San Antonio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Creatine Supplement Group

Exercise Only Control Group

Arm 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.

Participants will not participate in the creatine intervention (creatine supplementation). Participants will engage in three center-based exercise sessions each week for 12 weeks; each session lasting roughly 1-hour. Exercise sessions will be held by trained study staff held at the Medical Arts and Research Center Physical Therapy clinic (address listed above).

Outcomes

Primary Outcome Measures

Change in strength in breast cancer survivors
Participants will be evaluated for knee extensor strength via isometric maximum voluntary contraction at approximately 60° knee flexion.
Change in functional capacity in breast cancer survivors
Functional exercise capacity will be assessed via the 6 minute walk test (6MWT).

Secondary Outcome Measures

Change in intramuscular creatine and altering energy storage.
Muscle Creatine, Phosphocreatine, and Adenosine-triphosphate content will be assessed in vivo by 31P-MRS using a whole body 3.0T MRI scanner.
Change in muscle cross sectional area
Magnetic resonance imaging will be used to capture the mid-thigh cross section.

Full Information

First Posted
December 16, 2019
Last Updated
July 21, 2023
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
ThriveWell Cancer Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04207359
Brief Title
Effects of Creatine Supplementation in Breast Cancer Survivors
Official Title
The THRIVE Study: An Open-Label Randomized Trial of Exercise ± Creatine Supplementation to Augment the Adaptations of Exercise Training in Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 30, 2020 (Actual)
Primary Completion Date
March 7, 2023 (Actual)
Study Completion Date
March 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
ThriveWell Cancer Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to test the hypothesis that creatine will accelerate adaptations associated with exercise in breast cancer survivors recently completing chemotherapy.
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 hypothesis for this objective is that creatine will lead to significantly greater gains in strength and physical function in breast cancer survivors compared to exercise alone. The secondary objective is to determine if supplemental creatine can increase intramuscular storage of creatine and alter energy storage. The hypothesis for this objective is that creatine supplementation will significantly increase intramuscular concentrations of creatine (Cr), phosphocreatine (PCr) and adenosine triphosphate (ATP) in the vastus lateralis (VL) compared to controls. The secondary hypothesis for this objective is that the creatine group will have significantly greater muscle cross-sectional area and significantly lower intramuscular fat compared to controls. The final objective for this study is to test the hypothesis that creatine supplementation will improve body composition in breast cancer survivors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Chemotherapy Effect, Muscle Weakness, Muscle Loss, Exercise
Keywords
Special Populations, Exercise Oncology, Creatine Supplementation, Magnetic Resonance Spectroscopy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study plans to enroll 30 breast cancer patients who have completed chemotherapy within 6 months prior to consenting for this study. Patients eligible to participate in this study will be allocated to either the creatine group or the control group (1:1) based on a pre-determined randomization list. Each arm will have 15 participants. One arm will receive creatine and the other will serve as the control group with no creatine.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Creatine Supplement Group
Arm Type
Experimental
Arm 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.
Arm Title
Exercise Only Control Group
Arm Type
No Intervention
Arm Description
Participants will not participate in the creatine intervention (creatine supplementation). Participants will engage in three center-based exercise sessions each week for 12 weeks; each session lasting roughly 1-hour. Exercise sessions will be held by trained study staff held at the Medical Arts and Research Center Physical Therapy clinic (address listed above).
Intervention Type
Dietary Supplement
Intervention Name(s)
Creatine
Intervention 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.
Primary Outcome Measure Information:
Title
Change in strength in breast cancer survivors
Description
Participants will be evaluated for knee extensor strength via isometric maximum voluntary contraction at approximately 60° knee flexion.
Time Frame
From baseline to 12 weeks
Title
Change in functional capacity in breast cancer survivors
Description
Functional exercise capacity will be assessed via the 6 minute walk test (6MWT).
Time Frame
From baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Change in intramuscular creatine and altering energy storage.
Description
Muscle Creatine, Phosphocreatine, and Adenosine-triphosphate content will be assessed in vivo by 31P-MRS using a whole body 3.0T MRI scanner.
Time Frame
From baseline to 12 weeks
Title
Change in muscle cross sectional area
Description
Magnetic resonance imaging will be used to capture the mid-thigh cross section.
Time Frame
From baseline to 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-75 years of age Recent (within 6 months) completion of chemotherapy Willing to attend 3 virtual 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: 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 Currently undergoing chemotherapy 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 get pregnant during the study Recent (within one month) or anticipated treatment with corticosteroids (except for short term use during the time of chemotherapy), androgens, progestational agents, 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darpan I Patel, PhD
Organizational Affiliation
UT Health San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Health San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35363152
Citation
Patel DI, Gonzalez A, Moon C, Serra M, Bridges PB, Hughes D, Clarke G, Kilpela L, Jiwani R, Musi N. Exercise and Creatine Supplementation to Augment the Adaptation of Exercise Training Among Breast Cancer Survivors Completing Chemotherapy: Protocol for an Open-label Randomized Controlled Trial (the THRIVE Study). JMIR Res Protoc. 2022 Apr 1;11(4):e26827. doi: 10.2196/26827.
Results Reference
derived

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Effects of Creatine Supplementation in Breast Cancer Survivors

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