<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20251211068287N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-09-11</date_registration>
      <primary_sponsor>University of Tehran</primary_sponsor>
      <public_title>The impact of physical activity on the gut microbiome in breast cancer survivors</public_title>
      <acronym></acronym>
      <scientific_title>The effect of 12 weeks of combined training (aerobic + resistance) on gut microbiome abundance, inflammatory markers, and psychological symptoms in breast cancer survivors</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Pending</recruitment_status>
      <url>https://irct.ir/trial/93128</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The randomization method in this study will be block randomization with variable block sizes (2 and 4), with the individual as the unit of randomization. The randomization sequence will be generated prior to the start of recruitment by a biostatistician using the online software Sealed Envelope. To ensure allocation concealment, sequentially numbered, opaque, sealed envelopes will be prepared by a researcher independent of the study team. After baseline assessments and obtaining informed consent, the next envelope will be opened in sequence to reveal the group assignment (exercise or control) for each participant. This is an open‑label trial, and no stratification will be applied in the randomization process.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Breast cancer survivors.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: combine exercise training:The intervention duration is 12 weeks (resistance training: 30-35 minutes; aerobic training: 25-30 minutes). Sessions are conducted 3 times per week on non-consecutive days. Session duration: Each training session lasts approximately 60 to 70 minutes. Intervention 2: Control group: No regular physical activity.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is IPD will not be shared due to ethical and privacy concerns, as the data include sensitive genomic and psychological information that could potentially compromise participant confidentiality even after de-identification. The study protocol and informed consent form do not include provisions for data sharing beyond the primary research team</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Najmeh Rezaeinenezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, North Kargar Street, north of the Jalal‑e‑Ahmad intersection, between 15th and 16th Streets, North Campus, Faculty of Sport Sciences and Health, University of Tehran</address>
        <city>تهران</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14398-13117</zip>
        <telephone>+98 21 6111 2871</telephone>
        <email>najmeh_rn@yahoo.com</email>
        <affiliation>University of Tehran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Najmeh Rezaeinezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Karegar</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14398-13117</zip>
        <telephone>+98 21 6111 8820</telephone>
        <email>n.rezaeinezhad@ut.ac.ir</email>
        <affiliation>University of tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women aged 18 to 45 years
At least 6 months and at most 5 years since completion of adjuvant therapies (chemotherapy, radiotherapy, and hormone therapy)
No regular physical activity in the past 6 months (less than 30 minutes of moderate‑intensity activity per day, on fewer than 3 days per week)
No regular physical activity in the past 6 months (less than 30 minutes of moderate‑intensity activity per day, on fewer than 3 days per week)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Presence of uncontrolled cardiovascular diseases (uncontrolled hypertension, heart failure, life‑threatening arrhythmias)
Presence of uncontrolled metabolic disorders (poorly controlled type 1 or type 2 diabetes)
Diagnosis of chronic inflammatory diseases (e.g., rheumatoid arthritis, lupus, inflammatory bowel diseases)
Use of antibiotics or probiotics within the past 3 months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C50.119</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of central portion of unspecified female breast</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: combine exercise training:The intervention duration is 12 weeks (resistance training: 30-35 minutes; aerobic training: 25-30 minutes). Sessions are conducted 3 times per week on non-consecutive days. Session duration: Each training session lasts approximately 60 to 70 minutes</i_keyword>
      <i_keyword>Control group: No regular physical activity</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Relative abundance of key bacterial genera or species in stool samples of participants. Timepoint: Two time points: Baseline (week 0) and Post‑intervention (week 12). Method of measurement: Stool samples will be collected at baseline (before intervention) and at the end of the study (after 12 weeks).</prim_outcome>
      <prim_outcome>Measurement of serum levels of certain cytokines and inflammatory in participants' blood. Timepoint: Two time points: Baseline (week 0) and Post‑intervention (week 12). Method of measurement: Venous blood samples (5 mL) will be collected at two time points (baseline and post‑intervention).</prim_outcome>
      <prim_outcome>Assessment of psychological symptom severity, including depression, anxiety, stress, and quality of life in participants. Timepoint: Two time points: Baseline (week 0) and Post‑intervention (week 12). Method of measurement: Standardized questionnaires will be completed by participants at two time points (baseline and post‑intervention).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>student</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-08-31</approval_date>
        <contact_name>Ethics Committee for Research of the Faculty of Sport Sciences and Health, University of Tehran</contact_name>
        <contact_address>Tehran, North Kargar Street, north of the Jalal‑e‑Ahmad intersection, between 15th and 16th Streets, North Campus, Faculty of Sport Sciences and Health, University of Tehran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
