Creatine for Breast Cancer Survivors

(THRIVE Trial)

Overseen By Rebecca Geck, MPH,APRN,CPT

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: The University of Texas Medical Branch, Galveston

Must not be taking: Anabolic steroids, Corticosteroids, Creatine

Disqualifiers: Hypertension, Heart disease, Pulmonary disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking creatine supplements or have recently used corticosteroids or appetite stimulants. It's best to discuss your specific medications with the trial coordinators.

Is creatine safe for breast cancer survivors?

Creatine monohydrate is generally considered safe for healthy adults, with a recommended daily intake of 3 grams unlikely to pose safety concerns. Some mild side effects like gastrointestinal issues and muscle cramps have been reported, but no serious adverse outcomes have been associated with its use in females. However, specific safety data for breast cancer survivors is limited, so it's important to consult with a healthcare provider before starting supplementation. ^{1 2 3 4 5}

How does the drug Creatine differ from other treatments for breast cancer survivors?

Creatine is unique because it is a supplement commonly used to improve muscle strength and energy, which may help breast cancer survivors with muscle recovery and overall physical fitness. Unlike traditional cancer treatments, it focuses on enhancing physical performance and body composition rather than directly targeting cancer cells. ^{6 7 8 9 10}

Research Team

Darpan Patel, PhD

Principal Investigator

University of Texas

Eligibility Criteria

This trial is for breast cancer survivors who have completed chemotherapy, aiming to improve their strength and endurance. It's also for healthy women of the same age without a history of breast cancer, to compare results.

Inclusion Criteria

I finished my chemotherapy for breast cancer within the last 6 months.

Breast Cancer Group: Participant is willing and able to provide consent to participating in the study

Breast Cancer Group: Willing to attend 3 virtual-based exercise sessions per week

Exclusion Criteria

Breast Cancer Group: Lack of availability to a smartphone and/or internet

Healthy Age-matched Control Group: Physical indications where performing exercise may be limited and/or contraindicated

Healthy Age-matched Control Group: Current tobacco use (within 6 months)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in exercise sessions and receive creatine supplementation for 12 weeks

12 weeks

3 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Creatine

Trial Overview The study tests if creatine supplements can boost exercise response in terms of muscle power and overall fitness among breast cancer survivors compared to healthy peers.

Participant Groups

Group I: Creatine Supplement Group Experimental Treatment 1 Intervention

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.

Group II: Age-Matched Control Group Active Control 1 Intervention

Women who have never been diagnosed with cancer.

Group III: Non-Creatine Supplement Group Active Control 1 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.

Creatine is already approved in United States, European Union for the following indications:

Approved in United States as Creatine Monohydrate for:

• Dietary supplement for muscle growth and performance
• Potential treatment for post-concussive symptoms

Approved in European Union as Creatine Monohydrate for:

• Dietary supplement for muscle growth and performance
• Potential treatment for post-concussive symptoms

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials

263

Recruited

55,400+

ThriveWell Cancer Foundation

Collaborator

Trials

2

Recruited

80+

Findings from Research

Creatine monohydrate is generally considered safe for healthy adults at a daily intake of 3 grams, with some minor side effects like gastrointestinal issues and muscle cramps reported.

While most creatine forms are unlikely to pose safety concerns, there are specific safety concerns associated with creatine orotate, creatine phosphate, and magnesium creatine chelate, indicating that not all creatine supplements are equally safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creatine and creatine forms intended for sports nutrition. Andres, S., Ziegenhagen, R., Trefflich, I., et al.[2018]

Creatine monohydrate (CrM) remains the only form of creatine with substantial evidence supporting its bioavailability, efficacy, and safety, as confirmed by a review of various marketed creatine forms.

Despite ongoing claims about other 'novel forms' of creatine, many lack sufficient evidence for effectiveness and safety, and CrM is still the recommended source by professional organizations and regulatory authorities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioavailability, Efficacy, Safety, and Regulatory Status of Creatine and Related Compounds: A Critical Review. Kreider, RB., Jäger, R., Purpura, M.[2022]

A systematic review of 29 studies involving 951 female participants found no serious adverse outcomes or deaths associated with creatine monohydrate (CrM) supplementation, indicating it is safe for use in women.

There were no significant differences in total adverse events, gastrointestinal issues, or weight gain between those taking CrM and those not, suggesting that CrM does not increase the risk of these complications in females.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of Adverse Outcomes in Females Taking Oral Creatine Monohydrate: A Systematic Review and Meta-Analysis. de Guingand, DL., Palmer, KR., Snow, RJ., et al.[2021]

Acute creatine monohydrate supplementation (20 g per day for 5 days) significantly increased fat-free mass and total body mass in both men and women, with a more pronounced effect in men.

The study found no adverse effects on blood pressure, renal function, or muscle enzyme activity, indicating that creatine is safe for use in both genders during high-intensity exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute creatine loading increases fat-free mass, but does not affect blood pressure, plasma creatinine, or CK activity in men and women. Mihic, S., MacDonald, JR., McKenzie, S., et al.[2019]

Creatine monohydrate is an effective sports supplement that helps maintain high-energy phosphate levels during exercise, leading to benefits like increased muscle mass and potential neural protection.

While creatine supplementation has many positive effects, there are concerns about side effects such as muscle cramping and the presence of impurities, which warrant careful consideration of its safety and quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creatine: are the benefits worth the risk? Brudnak, MA.[2013]

A review of 1,314 studies identified only 14 that examined the effects of exercise on body weight and composition in breast cancer survivors, indicating a lack of comprehensive research in this area.

While exercise may help manage body composition changes, the current evidence is limited and suggests that future studies should prioritize these outcomes to better inform clinical practices for breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of exercise on body weight and composition in breast cancer survivors: an integrative systematic review. Ingram, C., Courneya, KS., Kingston, D.[2018]

A 3-month lifestyle intervention using wearable devices and health education significantly reduced body weight, fat mass, BMI, body fat percentage, and visceral fat area in 113 breast cancer survivors, indicating its efficacy in improving body composition.

Despite improvements in overall body composition, the intervention did not significantly affect protein mass or skeletal muscle mass, suggesting that while weight loss was achieved, muscle preservation may require additional strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Short-Term Effect of Wearable Technology-Based Lifestyle Intervention on Body Composition in Stage I-III Postoperative Breast Cancer Survivors. Zhou, C., Mo, M., Wang, Z., et al.[2022]

An individualized remote exercise program significantly improved body composition and physical fitness in 107 women who completed breast cancer treatment, with 72.8% adherence to the program leading to notable reductions in body mass, body fat, and increases in maximal oxygen consumption.

Participants who adhered to the exercise program experienced substantial benefits, while those who did not adhere showed no significant changes, highlighting the importance of commitment to the program for achieving health improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A remote, fully oriented personalized program of physical exercise for women in follow-up after breast cancer treatment improves body composition and physical fitness. França-Lara, ÉG., Weber, SH., Pinho, RA., et al.[2023]

The From Surviving to Thriving (FST) Colloquium significantly improved breast cancer survivors' knowledge of exercise and nutrition, with self-perceived knowledge ratings increasing from 8.9% to 44.4% after the event.

The Colloquium was well-received, with 84.4% of breast cancer survivors and 93.3% of healthcare providers rating their experience as very good, indicating its effectiveness in promoting positive behavior changes related to exercise and wellness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From surviving to thriving: a health and wellness colloquium for breast cancer survivors. Stoutenberg, M., Cutrono, S., Perry, AC.[2021]

The ENERGY study is a 4-year clinical trial involving 693 overweight or obese women with early-stage breast cancer, aimed at demonstrating the feasibility of sustained weight loss and its impact on quality of life and co-morbidities.

The trial's intervention includes a cognitive-behavioral weight loss program, which could establish weight loss support as a new standard of care for breast cancer survivors, potentially improving their clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing breast cancer recurrence with weight loss, a vanguard trial: the Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial. Rock, CL., Byers, TE., Colditz, GA., et al.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Creatine and creatine forms intended for sports nutrition. [2018]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Bioavailability, Efficacy, Safety, and Regulatory Status of Creatine and Related Compounds: A Critical Review. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Risk of Adverse Outcomes in Females Taking Oral Creatine Monohydrate: A Systematic Review and Meta-Analysis. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Acute creatine loading increases fat-free mass, but does not affect blood pressure, plasma creatinine, or CK activity in men and women. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Creatine: are the benefits worth the risk? [2013]

6. United States pubmed.ncbi.nlm.nih.gov

The effects of exercise on body weight and composition in breast cancer survivors: an integrative systematic review. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

A Short-Term Effect of Wearable Technology-Based Lifestyle Intervention on Body Composition in Stage I-III Postoperative Breast Cancer Survivors. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

A remote, fully oriented personalized program of physical exercise for women in follow-up after breast cancer treatment improves body composition and physical fitness. [2023]

9. England pubmed.ncbi.nlm.nih.gov

From surviving to thriving: a health and wellness colloquium for breast cancer survivors. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Reducing breast cancer recurrence with weight loss, a vanguard trial: the Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial. [2021]