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

Primary Purpose

Breast Cancer, Supplementation, Resistance Training

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Creatine supplementation
Resistance training
Sponsored by
University of Deusto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    Experimental

    Arm Label

    Control Group

    Resistance training group

    Resistance training and creatine supplementation group

    Arm Description

    They receive physical activity and nutrition recommendations.

    They will perform resistance training and placebo in the supplementation.

    They will perform the same resistance training and will also receive creatine supplementation

    Outcomes

    Primary Outcome Measures

    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.
    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).
    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).

    Secondary Outcome Measures

    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.
    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.
    Change in Body composition
    Body composition (percentages of type of tissue) will be measured using a bioelectrical impedance analysis (Inbody 770, In-Bldg).
    Change in dietary pattern
    Habitual food consumption and nutrient intake will be evaluated using the dietary history questionnaire.
    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)].
    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.
    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).
    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.

    Full Information

    First Posted
    April 27, 2023
    Last Updated
    May 26, 2023
    Sponsor
    University of Deusto
    Collaborators
    Hospital de Cruces, Hospital de Basurto, Poznan University of Medical Sciences, Hospital Universitario de Burgos, University of Americas, University of Calabria
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05878106
    Brief Title
    Creatine Supplementation and Resistance Training in Patients With Breast Cancer
    Acronym
    CaRTiC
    Official Title
    Creatine Supplementation and Resistance Training in Patients With Breast Cancer (CaRTiC Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 8, 2024 (Anticipated)
    Primary Completion Date
    April 20, 2025 (Anticipated)
    Study Completion Date
    December 8, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Deusto
    Collaborators
    Hospital de Cruces, Hospital de Basurto, Poznan University of Medical Sciences, Hospital Universitario de Burgos, University of Americas, University of Calabria

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer, Supplementation, Resistance Training, Physical Performance, Quality of Life

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    They receive physical activity and nutrition recommendations.
    Arm Title
    Resistance training group
    Arm Type
    Experimental
    Arm Description
    They will perform resistance training and placebo in the supplementation.
    Arm Title
    Resistance training and creatine supplementation group
    Arm Type
    Experimental
    Arm Description
    They will perform the same resistance training and will also receive creatine supplementation
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Creatine supplementation
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Resistance training
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in maximal resistance (upper and lower body)
    Description
    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.
    Time Frame
    7 months follow up. Measures at 0, 2, 4 and 7 months.
    Title
    Genetic study
    Description
    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).
    Time Frame
    Month 0
    Title
    Change in Micro RNA (mRNA)
    Description
    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).
    Time Frame
    Month 0 and 4
    Secondary Outcome Measure Information:
    Title
    Change in Physical function (walking)
    Description
    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.
    Time Frame
    7 months follow up. Measures at 0, 2, 4 and 7 months.
    Title
    Change in Physical function (sitting)
    Description
    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.
    Time Frame
    7 months follow up. Measures at 0, 2, 4 and 7 months.
    Title
    Change in Body composition
    Description
    Body composition (percentages of type of tissue) will be measured using a bioelectrical impedance analysis (Inbody 770, In-Bldg).
    Time Frame
    7 months follow up. Measures at 0, 2, 4 and 7 months.
    Title
    Change in dietary pattern
    Description
    Habitual food consumption and nutrient intake will be evaluated using the dietary history questionnaire.
    Time Frame
    7 months follow up. Measures at 0, 2, 4 and 7 months.
    Title
    Change in Gastrointestinal discomfort
    Description
    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)].
    Time Frame
    7 months follow up. Measures at 0, 2, 4 and 7 months.
    Title
    Change in Quality of life (general)
    Description
    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.
    Time Frame
    7 months follow up. Measures at 0, 2, 4 and 7 months.
    Title
    Change in Quality of life (cancer specific)
    Description
    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).
    Time Frame
    7 months follow up. Measures at 0, 2, 4 and 7 months.
    Title
    Change in fatigue level
    Description
    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.
    Time Frame
    7 months follow up. Measures at 0, 2, 4 and 7 months.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Arkaitz Castañeda, PhD
    Phone
    944139003
    Ext
    3208
    Email
    arkaitz.castaneda@deusto.es
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Arkaitz Castañeda, PhD
    Organizational Affiliation
    University of Deusto
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Cella D, Nowinski CJ. Measuring quality of life in chronic illness: the functional assessment of chronic illness therapy measurement system. Arch Phys Med Rehabil. 2002 Dec;83(12 Suppl 2):S10-7. doi: 10.1053/apmr.2002.36959.
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    Creatine Supplementation and Resistance Training in Patients With Breast Cancer

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