THRIVE Well Cancer FDTN/Exercise_Creatine Supplementation

Breast Cancer Clinical Trial

— THRIVE  

Official title:

An Open-label Randomized Trial of Exercise ± Creatine Supplementation to Augment the Adaptations of Exercise Training in Cancer Survivors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06395506
• Other study ID #: 23-0215
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 30, 2024
• Est. completion date: May 31, 2028

Study information

• Verified date: May 2024
• Source: The University of Texas Medical Branch, Galveston
• Contact: Lisa Thibodeaux, RN,BSN
• Phone: 4094741756
• Email: lbthibod[@]utmb.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 31, 2028
• Est. primary completion date: May 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Female
• Breast Neoplasms
• Muscle Weakness

Intervention

Dietary Supplement:
• Creatine
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.

Locations

Country	Name	City	State
United States	The University of Texas Medical Branch, Galveston	Galveston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston	ThriveWell Cancer Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change intramuscular storage of creatine	Determine the change in intramuscular storage of creatine by comparing pre and post vastus lateralis muscle using MRI.	baseline and 12 weeks
Secondary	Change in body composition in cancer survivors	Determine the change in body composition in breast cancer survivors by pre and post measurements of bone mass as well as lean vs fat mass via a DEXA scan.	baseline and 12 weeks
Secondary	Change in the return of strength for breast cancer survivors with creatine + exercise	Breast cancer survivors who complete 12-weeks of exercise with creatine supplementation group who regained strength and physical function to that of women of similar age who never had cancer.	12 weeks