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Creatine for Breast Cancer

N/A

Waitlist Available

Led By Darpan I Patel, PhD

Research Sponsored by The University of Texas Health Science Center at San Antonio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 12 weeks

Awards & highlights

Study Summary

This trial will test whether creatine can help breast cancer patients who have recently completed chemotherapy by helping them to better adapt to exercise.

Eligible Conditions

Breast Cancer
Muscle Weakness
Chemotherapy Side Effects
Muscle Atrophy
Exercise

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in functional capacity in breast cancer survivors

Change in strength in breast cancer survivors

Secondary outcome measures

Change in intramuscular creatine and altering energy storage.

Change in muscle cross sectional area

Side effects data

From 2015 Phase 3 trial • 50 Patients • NCT02188849

18%

Pain

14%

Falls

14%

Gastroinftestinal symptoms

Fever

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Creatine

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Creatine Supplement GroupExperimental Treatment1 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.

Group II: Exercise Only Control GroupActive Control1 Intervention

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Creatine

2014

Completed Phase 4

~670

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

ThriveWell Cancer FoundationUNKNOWN

The Claude D. Pepper Older Americans Independence CentersOTHER

9 Previous Clinical Trials

278 Total Patients Enrolled

The University of Texas Health Science Center at San AntonioLead Sponsor

452 Previous Clinical Trials

91,394 Total Patients Enrolled

14 Trials studying Breast Cancer

1,520 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial currently have slots available for participants?

"Affirmative. Details on clinicaltrials.gov demonstrate that this medical experiment, first made available on September 30th 2020, is presently recruiting patients to fill the quota of thirty participants at a single location."

Answered by AI

For what type of individual is this clinical trial most suitable?

"This clinical trial seeks 30 individuals with breast cancer between 18 and 75 years of age. To qualify, they must agree to provide their consent for the study, have recently finished chemotherapy within 6 months, be amenable to attending 3 virtual exercise sessions weekly, able to receive oral medications without difficulty and possess a serum creatinine ≤ 1.5 x ULN or an eGFR score ≥30 mL/min/1.73 m2 as established by Chronic Kidney Disease Epidemiology Collaboration equation.."

Answered by AI

Is eligibility for this research project exclusive to individuals over 65 or do those younger than that also have access?

"This clinical trial has a minimum age requirement of 18 and an upper limit set at 75 years old."

Answered by AI

How many participants are being accepted for inclusion in this clinical trial?

"Affirmative. According to clinicaltrials.gov, this clinical research is currently in search of participants. It was first posted on September 30th 2020 and most recently updated on October 10th 2022 with the intention of enrolling a total of 30 patients across 1 site."

Answered by AI