Creatine Supplementation and Resistance Training in Patients With Breast Cancer (CaRTiC)

December 4, 2023 updated by: Arkaitz Castañeda, University of Deusto

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

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 sarcopenia. The potential of creatine supplementation for adaptations produced by strength training in cancer patients are still unknown.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).
  • 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).

Exclusion Criteria:

  • 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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
They receive physical activity and nutrition recommendations.
Experimental: Resistance training group
They will perform resistance training and placebo in the supplementation.
Other: Resistance training
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.
Experimental: Resistance training and creatine supplementation group
They will perform the same resistance training and will also receive creatine supplementation
Other: Resistance training
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.
Dietary supplement: Creatine supplementation

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Month 0
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).
Month 0 and 4
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.
7 months follow up. Measures at 0, 2, 4 and 7 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body composition
Time Frame: 7 months follow up. Measures at 0, 2, 4 and 7 months.
Body composition (percentages of type of tissue) will be measured using a bioelectrical impedance analysis (Inbody 770, In-Bldg).
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.
Habitual food consumption and nutrient intake will be evaluated using the dietary history questionnaire.
7 months follow up. Measures at 0, 2, 4 and 7 months.
Change in Physical function (walking)
Time Frame: 7 months follow up. Measures at 0, 2, 4 and 7 months.
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.
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.
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.
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.
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)].
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.
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.
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.
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).
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.
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.
7 months follow up. Measures at 0, 2, 4 and 7 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Deusto

Collaborators

Poznan University of Medical Sciences
Hospital de Basurto
Hospital de Cruces
Hospital Universitario de Burgos
University of Calabria
Dynamical Business & Science Society - DBSS

Investigators

  • Principal Investigator: Arkaitz Castañeda, PhD, University of Deusto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 8, 2024

Primary Completion (Estimated)

April 20, 2025

Study Completion (Estimated)

December 8, 2025

Study Registration Dates

First Submitted

April 27, 2023

First Submitted That Met QC Criteria

May 25, 2023

First Posted (Actual)

May 26, 2023

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CaRTiC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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