Breast CancerCaRTiCNCT05878106

Creatine Supplementation and Resistance Training in Patients With Breast Cancer

A study testing Creatine supplementation and Resistance training in people with Breast Cancer and Supplementation, run by University of Deusto at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Background: Creatine supplementation is an effective ergogenic nutrient for athletes, as well as people for people starting a health or fitness program. Resistance training previously been identified as an important method of increasing muscle mass and strength among people, specially in people with cancer to avoid… Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Breast Cancer, Supplementation, Resistance Training
What is being tested?: Creatine supplementation and Resistance training
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteSpain
Study dates: 8 Apr 2024to 8 Dec 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Stage pTis-T1-T2-T3 pN0-1 M0 (early stage).
Patients who have completed local treatment [surgery + radiotherapy (RT)] undergoing clinical follow-up in outpatient clinics with or without adjuvant hormone therapy treatment.
Age: ≥18-60 years.
ECOG Performance status from 0 to 1 (IK ≥80%).
Body mass index above than 18.5.
Without excessive alcohol consumption (men > 21 and women > 14 units/week).

Show all 10Show fewer

No current or previous illness or injury that may prevent participation and training.
No recent systematic strength training.
Not taking medications that are known to alter body composition (corticosteroids, metformin...).
People who carry out some aerobic training will not be excluded (the activity carried out will be recorded weekly).

Who cannot join

Having received adjuvant or neoadjuvant chemotherapy.
Metastatic carcinoma of the breast.
Recurrence or second primary breast.
History of previous cancer except previously treated basal cell carcinoma of the skin.
Decompensated heart disease, uncontrolled hypertension (TAS>200 or TAD>110), heart failure (NYHA II or greater), heart failure or constrictive pericarditis, neutropenia, severe anemia (Hb<8.0 g/dl), blood count platelets <50,000 microL.
Other health problems in which exercise is contraindicated

Show all 9Show fewer

Perform regular physical activity (150 min/week of moderate activity or 75 of vigorous activity), measured with the PVS questionnaire.
Pregnancy.
Criterion in the opinion of the investigator of inability to adequately understand the involvement and participation in this clinical study.

Trial locations and contacts

1 site in 1 country.

Arkaitz Castañeda, PhD contact

944139003 ext. 3208

arkaitz.castaneda@deusto.es

Spain1 site, 1 recruiting

Hospital de Cruces
Bilbao, Bizkaia, 48080
Jon Cacicedo, Dr, JON.CACICEDOFERNANDEZDEBOBADILLA@osakidetza.eus
Recruiting

Other trials in Spain

About this study

Official title: Creatine Supplementation and Resistance Training in Patients With Breast Cancer (CaRTiC Study)

Objective: the primary aim of this study is to evaluate the effectiveness of a 16-week supervised resistance training program intervention with and without creatine supplementation in patients with breast cancer.

Methods: A multicentre, randomized, double-blind, placebo-controlled study designed to evaluate the effects of creatine supplementation in addition to resistance training in breast cancer patients. Patients will be randomly assigned to 3 groups: a control group (CG) and two experimental groups. The first resistance training group (RG) will perform resistance training, while the second resistance-creatine experimental group (RCG) will perform the same resistance training as the RG and will also receive a 5 g/day supplementation of creatine for the duration of the exercise the 16-week intervention. RG participants will follow the same daily dosing protocol, but in their case, with dextrose/maltodextrin. Resistance training will be a 16-week supervised workout that will consist of a series of resistance exercises (leg press, knee extension, knee bends, chest press, sit-ups, back extensions, pull-ups, and shoulder press) that involved the largest muscle groups of the body and will be performed three times a week on non-consecutive days. Both the RG and the RCG will receive a supplement of soluble protein powder (20-30 g) daily.

Discussion: The results of this intervention will help to better understand the potential of non-pharmacological treatment for improving strength and wellbeing values in breast cancer patients with and without creatine supplementation.

Conditions: Breast Cancer, Supplementation, Resistance Training, Physical Performance, Quality of Life
Being tested: Creatine supplementation, Resistance training
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Creatine supplementationDietary supplement
5 g/day supplementation of creatine for the duration of the exercise the 16-week intervention.
The RG and the RCG will receive a supplement of soluble protein powder (20-30 g) daily.
Resistance trainingOther
They will do resistance training. Resistance training will be a 16-week supervised workout that will consist of a series of resistance exercises (leg press, knee extension, knee bends, chest press, sit-ups, back extensions, pull-ups, and shoulder press) that involved the largest muscle groups of the body and will be performed three times a week on non-consecutive days.

Study groups in NCT05878106
Study group	Role	What they receive
Control Group	No intervention	They receive physical activity and nutrition recommendations.
Resistance training group	Experimental	They will perform resistance training and placebo in the supplementation. Receives: Other: Resistance training
Resistance training and creatine supplementation group	Experimental	They will perform the same resistance training and will also receive creatine supplementation Receives: Dietary Supplement: Creatine supplementation; Other: Resistance training

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in maximal resistance (upper and lower body)
The maximal resistance in the upper and lower body will be measured in terms of the 5-repetition maximum test (5RM) (i.e. the maximum load that can be lifted five times) in chest and leg press exercises, respectively. Also a handgrip dynamometry test will be used to measure grip resistance.
Measured: 7 months follow up. Measures at 0, 2, 4 and 7 months.
Genetic study
Saliva samples will be taken from the participants using buccal swabs (4N6FLOQSwab, Life Technologies, Carlsbad, CA). The genetic analysis will be performed using Biomark HD system microfluidic analysis technology (Fluidigm, South San Francisco, CA). From that analysis DNA will be extracted using the QIAmp DNA Mini kit (Qiagen, Hilden, Germany) and will be quantified fluorometrically using Qubit (LifeTechnologies).
Measured: Month 0
Change in Micro RNA (mRNA)
A 5/10 ml of urine will be collected in a 15 ml sterile plastic universal container tube kept at room temperature no more than 60 minutes, then stored at -20°C. Total RNA will be extracted from 400 μl of urine by using miRNeasy Serum/Plasma Kit (QIAGEN).
Measured: Month 0 and 4

Secondary outcomes (8)

Change in Physical function (walking)
Physical function is assessed by the 6 Minute Walk Test (6MWT) in a 20-meter corridor. Is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Measured: 7 months follow up. Measures at 0, 2, 4 and 7 months.
Change in Physical function (sitting)
A 30-s chair test will be performed performed to measure functional capacity. The number of stands a person can complete in 30 seconds will be recorded.
Measured: 7 months follow up. Measures at 0, 2, 4 and 7 months.
Change in Body composition
Body composition (percentages of type of tissue) will be measured using a bioelectrical impedance analysis (Inbody 770, In-Bldg).
Measured: 7 months follow up. Measures at 0, 2, 4 and 7 months.
Change in dietary pattern
Habitual food consumption and nutrient intake will be evaluated using the dietary history questionnaire.
Measured: 7 months follow up. Measures at 0, 2, 4 and 7 months.
Change in Gastrointestinal discomfort
The unidimensional Gastrointestinal Function questionnaire was used to assess gastrointestinal discomfort. This questionnaire consists of 9 items with a frequency scale of 4 response options [none (0 points), mild (1 point), moderate (2 points) and severe (3 points)].
Measured: 7 months follow up. Measures at 0, 2, 4 and 7 months.
Change in Quality of life (general)
The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) is used to assess general health-related quality of life status across physical functioning, physical role functioning, bodily pain, general health, vitality, social functioning, emotional role functioning, and mental health domains (higher scores indicating a greater quality of life). with scores for each of these scales (or dimensions) ranging from 0 to 100. Higher scores indicate higher quality of life.
Measured: 7 months follow up. Measures at 0, 2, 4 and 7 months.
Change in Quality of life (cancer specific)
Cancer-specific quality of life is evaluated by the core quality of life (QLQ-C-30) questionnaire developed by the European Organization for Research and Treatment of Cancer (EORTC). This questionnaire includes five functional domains (physical, role, cognitive, emotional, and social, with higher scores representing greater function/quality of life) and three symptom scales (fatigue, pain, and nausea, with lower scores indicating greater quality of life/less symptom severity).
Measured: 7 months follow up. Measures at 0, 2, 4 and 7 months.
Change in fatigue level
The cancer-related fatigue is assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale. For all FACIT scales and symptom indices, the higher the score the better the quality of life.
Measured: 7 months follow up. Measures at 0, 2, 4 and 7 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Apr 20248 Dec 2025

First posted26 May 2023
Study start8 Apr 2024
Primary completion20 Apr 2025 (estimated)
Study completion8 Dec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (33)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05878106
Sponsor's protocol ID: CaRTiC
Acronym: CaRTiC
Status last verified: May 2024
First submitted: 27 Apr 2023
Last updated: 9 May 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Boidin M, Dawson EA, Thijssen DHJ, Erskine RM. VEGFA rs2010963 GG genotype is associated with superior adaptations to resistance versus endurance training in the same group of healthy, young men. Mol Genet Genomics. 2023 Jan;298(1):119-129. doi: 10.1007/s00438-022-01965-4. Epub 2022 Nov 3.
PubMed 36326960
Brosnan ME, Brosnan JT. The role of dietary creatine. Amino Acids. 2016 Aug;48(8):1785-91. doi: 10.1007/s00726-016-2188-1. Epub 2016 Feb 13.
PubMed 26874700
Buford TW, Kreider RB, Stout JR, Greenwood M, Campbell B, Spano M, Ziegenfuss T, Lopez H, Landis J, Antonio J. International Society of Sports Nutrition position stand: creatine supplementation and exercise. J Int Soc Sports Nutr. 2007 Aug 30;4:6. doi: 10.1186/1550-2783-4-6. No abstract available.
PubMed 17908288
Campos-Ferraz PL, Gualano B, das Neves W, Andrade IT, Hangai I, Pereira RT, Bezerra RN, Deminice R, Seelaender M, Lancha AH. Exploratory studies of the potential anti-cancer effects of creatine. Amino Acids. 2016 Aug;48(8):1993-2001. doi: 10.1007/s00726-016-2180-9. Epub 2016 Feb 12.
PubMed 26872655
Candow DG, Forbes SC, Chilibeck PD, Cornish SM, Antonio J, Kreider RB. Effectiveness of Creatine Supplementation on Aging Muscle and Bone: Focus on Falls Prevention and Inflammation. J Clin Med. 2019 Apr 11;8(4):488. doi: 10.3390/jcm8040488.
PubMed 30978926
Chen JF, Tao Y, Li J, Deng Z, Yan Z, Xiao X, Wang DZ. microRNA-1 and microRNA-206 regulate skeletal muscle satellite cell proliferation and differentiation by repressing Pax7. J Cell Biol. 2010 Sep 6;190(5):867-79. doi: 10.1083/jcb.200911036.
PubMed 20819939
Cornelissen VA, Defoor JG, Stevens A, Schepers D, Hespel P, Decramer M, Mortelmans L, Dobbels F, Vanhaecke J, Fagard RH, Vanhees L. Effect of creatine supplementation as a potential adjuvant therapy to exercise training in cardiac patients: a randomized controlled trial. Clin Rehabil. 2010 Nov;24(11):988-99. doi: 10.1177/0269215510367995. Epub 2010 Jun 24.
PubMed 20576665
Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
PubMed 30312372
Dolan E, Artioli GG, Pereira RMR, Gualano B. Muscular Atrophy and Sarcopenia in the Elderly: Is There a Role for Creatine Supplementation? Biomolecules. 2019 Oct 23;9(11):642. doi: 10.3390/biom9110642.
PubMed 31652853
Erskine RM, Williams AG, Jones DA, Stewart CE, Degens H. The individual and combined influence of ACE and ACTN3 genotypes on muscle phenotypes before and after strength training. Scand J Med Sci Sports. 2014 Aug;24(4):642-8. doi: 10.1111/sms.12055. Epub 2013 Feb 5.
PubMed 23384112
Fairman CM, Kendall KL, Newton RU, Hart NH, Taaffe DR, Chee R, Tang CI, Galvao DA. Examining the effects of creatine supplementation in augmenting adaptations to resistance training in patients with prostate cancer undergoing androgen deprivation therapy: a randomised, double-blind, placebo-controlled trial. BMJ Open. 2019 Sep 20;9(9):e030080. doi: 10.1136/bmjopen-2019-030080.
PubMed 31542747
Fenech M, El-Sohemy A, Cahill L, Ferguson LR, French TA, Tai ES, Milner J, Koh WP, Xie L, Zucker M, Buckley M, Cosgrove L, Lockett T, Fung KY, Head R. Nutrigenetics and nutrigenomics: viewpoints on the current status and applications in nutrition research and practice. J Nutrigenet Nutrigenomics. 2011;4(2):69-89. doi: 10.1159/000327772. Epub 2011 May 28.
PubMed 21625170
Gerland L, Baumann FT, Niels T. Resistance Exercise for Breast Cancer Patients? Evidence from the Last Decade. Breast Care (Basel). 2021 Dec;16(6):657-663. doi: 10.1159/000513129. Epub 2021 Jan 28.
PubMed 35087367
Giallauria F, Cittadini A, Smart NA, Vigorito C. Resistance training and sarcopenia. Monaldi Arch Chest Dis. 2016 Jun 22;84(1-2):738. doi: 10.4081/monaldi.2015.738.
PubMed 27374049
Hall M, Trojian TH. Creatine supplementation. Curr Sports Med Rep. 2013 Jul-Aug;12(4):240-4. doi: 10.1249/JSR.0b013e31829cdff2.
PubMed 23851411

Want to know more?

Arkaitz Castañeda, PhD

944139003 ext. 3208

arkaitz.castaneda@deusto.es

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Creatine Supplementation and Resistance Training in Patients With Breast Cancer (CaRTiC Study)
ClinicalTrials.gov ID: NCT05878106
Acronym / sponsor ID: CaRTiC / CaRTiC
Conditions: Breast Cancer, Supplementation, Resistance Training, Physical Performance, Quality of Life
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 120 participants (estimated)
Lead sponsor: University of DeustoUniversity, hospital or other
Collaborators: Hospital de Cruces, Hospital de Basurto, Poznan University of Medical Sciences, Hospital Universitario de Burgos, University of Calabria
Study start: 8 Apr 2024 (actual)
Primary completion: 20 Apr 2025 (estimated)
Study completion: 8 Dec 2025 (estimated)
First posted: 26 May 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 3

Arm	Type	Receives
Control Group	No intervention	–They receive physical activity and nutrition recommendations.
Resistance training group	Experimental	Other: Resistance trainingThey will perform resistance training and placebo in the supplementation.
Resistance training and creatine supplementation group	Experimental	Dietary Supplement: Creatine supplementation, Other: Resistance trainingThey will perform the same resistance training and will also receive creatine supplementation

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Stage pTis-T1-T2-T3 pN0-1 M0 (early stage).
Patients who have completed local treatment [surgery + radiotherapy (RT)] undergoing clinical follow-up in outpatient clinics with or without adjuvant hormone therapy treatment.
Age: ≥18-60 years.
ECOG Performance status from 0 to 1 (IK ≥80%).
Body mass index above than 18.5.

Key exclusion criteria (9 listed)

Having received adjuvant or neoadjuvant chemotherapy.
Metastatic carcinoma of the breast.
Recurrence or second primary breast.
History of previous cancer except previously treated basal cell carcinoma of the skin.
Decompensated heart disease, uncontrolled hypertension (TAS>200 or TAD>110), heart failure (NYHA II or greater), heart failure or constrictive pericarditis, neutropenia, severe anemia (Hb<8.0 g/dl), blood count platelets <50,000 microL.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Creatine supplementation5 g/day supplementation of creatine for the duration of the exercise the 16-week intervention. The RG and the RCG will receive a supplement of soluble protein powder (20-30 g) daily.	Dietary supplement	Resistance training and creatine supplementation group
Resistance trainingThey will do resistance training. Resistance training will be a 16-week supervised workout that will consist of a series of resistance exercises (leg press, knee extension, knee bends, chest press, sit-ups, back extensions, pull-ups, and shoulder press) that involved the largest muscle groups of the body and will be performed three times a week on non-consecutive days.	Other	Resistance training and creatine supplementation group, Resistance training group

Primary outcome

Change in maximal resistance (upper and lower body)
Time frame: 7 months follow up. Measures at 0, 2, 4 and 7 months.
The maximal resistance in the upper and lower body will be measured in terms of the 5-repetition maximum test (5RM) (i.e. the maximum load that can be lifted five times) in chest and leg press exercises, respectively. Also a handgrip dynamometry test will be used to measure grip resistance.
Genetic study
Time frame: Month 0
Saliva samples will be taken from the participants using buccal swabs (4N6FLOQSwab, Life Technologies, Carlsbad, CA). The genetic analysis will be performed using Biomark HD system microfluidic analysis technology (Fluidigm, South San Francisco, CA). From that analysis DNA will be extracted using the QIAmp DNA Mini kit (Qiagen, Hilden, Germany) and will be quantified fluorometrically using Qubit (LifeTechnologies).
Change in Micro RNA (mRNA)
Time frame: Month 0 and 4
A 5/10 ml of urine will be collected in a 15 ml sterile plastic universal container tube kept at room temperature no more than 60 minutes, then stored at -20°C. Total RNA will be extracted from 400 μl of urine by using miRNeasy Serum/Plasma Kit (QIAGEN).

8 secondary outcomes

Change in Physical function (walking)
Time frame: 7 months follow up. Measures at 0, 2, 4 and 7 months.
Change in Physical function (sitting)
Time frame: 7 months follow up. Measures at 0, 2, 4 and 7 months.
Change in Body composition
Time frame: 7 months follow up. Measures at 0, 2, 4 and 7 months.
Change in dietary pattern
Time frame: 7 months follow up. Measures at 0, 2, 4 and 7 months.
Change in Gastrointestinal discomfort
Time frame: 7 months follow up. Measures at 0, 2, 4 and 7 months.
Change in Quality of life (general)
Time frame: 7 months follow up. Measures at 0, 2, 4 and 7 months.
Change in Quality of life (cancer specific)
Time frame: 7 months follow up. Measures at 0, 2, 4 and 7 months.
Change in fatigue level
Time frame: 7 months follow up. Measures at 0, 2, 4 and 7 months.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
Background: PubMed 36326960Boidin M, Dawson EA, Thijssen DHJ, Erskine RM. VEGFA rs2010963 GG genotype is associated with superior adaptations to resistance versus endurance training in the same group of healthy, young men. Mol Genet Genomics. 2023 Jan;298(1):119-129. doi: 10.1007/s00438-022-01965-4. Epub 2022 Nov 3.
Background: PubMed 26874700Brosnan ME, Brosnan JT. The role of dietary creatine. Amino Acids. 2016 Aug;48(8):1785-91. doi: 10.1007/s00726-016-2188-1. Epub 2016 Feb 13.
Background: PubMed 17908288Buford TW, Kreider RB, Stout JR, Greenwood M, Campbell B, Spano M, Ziegenfuss T, Lopez H, Landis J, Antonio J. International Society of Sports Nutrition position stand: creatine supplementation and exercise. J Int Soc Sports Nutr. 2007 Aug 30;4:6. doi: 10.1186/1550-2783-4-6. No abstract available.
Background: PubMed 26872655Campos-Ferraz PL, Gualano B, das Neves W, Andrade IT, Hangai I, Pereira RT, Bezerra RN, Deminice R, Seelaender M, Lancha AH. Exploratory studies of the potential anti-cancer effects of creatine. Amino Acids. 2016 Aug;48(8):1993-2001. doi: 10.1007/s00726-016-2180-9. Epub 2016 Feb 12.
Background: PubMed 30978926Candow DG, Forbes SC, Chilibeck PD, Cornish SM, Antonio J, Kreider RB. Effectiveness of Creatine Supplementation on Aging Muscle and Bone: Focus on Falls Prevention and Inflammation. J Clin Med. 2019 Apr 11;8(4):488. doi: 10.3390/jcm8040488.
Background: PubMed 20819939Chen JF, Tao Y, Li J, Deng Z, Yan Z, Xiao X, Wang DZ. microRNA-1 and microRNA-206 regulate skeletal muscle satellite cell proliferation and differentiation by repressing Pax7. J Cell Biol. 2010 Sep 6;190(5):867-79. doi: 10.1083/jcb.200911036.
Background: PubMed 20576665Cornelissen VA, Defoor JG, Stevens A, Schepers D, Hespel P, Decramer M, Mortelmans L, Dobbels F, Vanhaecke J, Fagard RH, Vanhees L. Effect of creatine supplementation as a potential adjuvant therapy to exercise training in cardiac patients: a randomized controlled trial. Clin Rehabil. 2010 Nov;24(11):988-99. doi: 10.1177/0269215510367995. Epub 2010 Jun 24.
Background: PubMed 30312372Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
Background: PubMed 31652853Dolan E, Artioli GG, Pereira RMR, Gualano B. Muscular Atrophy and Sarcopenia in the Elderly: Is There a Role for Creatine Supplementation? Biomolecules. 2019 Oct 23;9(11):642. doi: 10.3390/biom9110642.
Background: PubMed 23384112Erskine RM, Williams AG, Jones DA, Stewart CE, Degens H. The individual and combined influence of ACE and ACTN3 genotypes on muscle phenotypes before and after strength training. Scand J Med Sci Sports. 2014 Aug;24(4):642-8. doi: 10.1111/sms.12055. Epub 2013 Feb 5.
Background: PubMed 31542747Fairman CM, Kendall KL, Newton RU, Hart NH, Taaffe DR, Chee R, Tang CI, Galvao DA. Examining the effects of creatine supplementation in augmenting adaptations to resistance training in patients with prostate cancer undergoing androgen deprivation therapy: a randomised, double-blind, placebo-controlled trial. BMJ Open. 2019 Sep 20;9(9):e030080. doi: 10.1136/bmjopen-2019-030080.
Background: PubMed 21625170Fenech M, El-Sohemy A, Cahill L, Ferguson LR, French TA, Tai ES, Milner J, Koh WP, Xie L, Zucker M, Buckley M, Cosgrove L, Lockett T, Fung KY, Head R. Nutrigenetics and nutrigenomics: viewpoints on the current status and applications in nutrition research and practice. J Nutrigenet Nutrigenomics. 2011;4(2):69-89. doi: 10.1159/000327772. Epub 2011 May 28.
Individual participant dataSharing planned: No

Related trials for Breast Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Arkaitz Castañeda, PhD contact

944139003 ext. 3208

arkaitz.castaneda@deusto.es

Arkaitz Castañeda, PhD principal investigator

University of Deusto

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Creatine supplementation and Resistance training in people with Breast Cancer and Supplementation, run by University of Deusto at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Arkaitz Castañeda, PhD (944139003 ext. 3208, arkaitz.castaneda@deusto.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in maximal resistance (upper and lower body) (time frame: 7 months follow up. Measures at 0, 2, 4 and 7 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05878106, which also lists 33 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.