The effect of 12 weeks of combined training (aerobic + resistance) on gut microbiome abundance, inflammatory markers, and psychological symptoms in breast cancer survivors
The effect of 12 weeks of combined exercise training on the abundance of gut bacteria, inflammatory markers, and psychological outcomes in breast cancer survivors
Design
This parallel-group RCT will enroll 30 breast cancer survivors (15 per group). After informed consent and baseline assessments, participants will be randomly assigned (1:1) to a 12‑week combined exercise group (aerobic + resistance, 3 sessions/week) or a no‑exercise control group using block randomization with variable block sizes (2 and 4).
Settings and conduct
This study will be conducted at the Tehran Sports Medicine Research Center, where eligible breast cancer survivors will be recruited. Orientation, baseline assessments, and informed consent will take place at the clinic. The exercise group will undergo a 12‑week combined program (3 sessions/week) at the facility under supervision, while the control group will attend only for assessments with no exercise intervention. All procedures will be physician‑coordinated and ethics‑approved.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women aged 18 to 45 years; At least 6 months and at most 5 years since completion of adjuvant therapies ; No regular physical activity in the past 6 months; Ability to perform exercise training as confirmed by the attending physician
Exclusion criteria: Presence of uncontrolled cardiovascular diseases ;Presence of uncontrolled metabolic disorders ;Diagnosis of chronic inflammatory diseases
Intervention groups
Combined exercise group: Participants in this group will engage in a combined exercise training program, including aerobic and resistance exercises, three sessions per week for 12 weeks
Control group: No regular physical activity
Main outcome variables
The primary outcome variables in this study include the abundance of selected gut bacteria, inflammatory markers, and psychological symptoms.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20251211068287N7
Registration date:2026-09-11, 1405/06/20
Registration timing:prospective
Last update:2026-09-11, 1405/06/20
Update count:0
Registration date
2026-09-11, 1405/06/20
Registrant information
Name
najmeh rezaeinezhad
Name of organization / entity
University of tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 6111 8820
Email address
n.rezaeinezhad@ut.ac.ir
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2026-09-23, 1405/07/01
Expected recruitment end date
2026-10-22, 1405/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
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
Public title
The impact of physical activity on the gut microbiome in breast cancer survivors
Purpose
Education/Guidance
Inclusion/Exclusion 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)
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
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee for Research of the Faculty of Sport Sciences and Health, University of Tehran
Street 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.
City
Tehran
Province
Tehran
Postal code
14398-13117
Approval date
2026-08-31, 1405/06/09
Ethics committee reference number
IR.UT.SPORT.REC.1405.076
Health conditions studied
1
Description of health condition studied
Breast cancer survivors
ICD-10 code
C50.119
ICD-10 code description
Malignant neoplasm of central portion of unspecified female breast
Primary outcomes
1
Description
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).
2
Description
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).
3
Description
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)
Secondary outcomes
empty
Intervention groups
1
Description
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
Category
Lifestyle
2
Description
Control group: No regular physical activity
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Cancer Institute of the Islamic Republic of Iran
Full name of responsible person
Dr. Kazem Zendehdel
Street address
Cancer Institute, Imam Khomeini Hospital Complex, End of Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6693 1444
Email
hosp_cancer@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Tehran
Full name of responsible person
Najmeh Rezaeinezhad
Street 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.
City
Tehran
Province
Tehran
Postal code
14398-13117
Phone
+98 21 6111 2871
Email
najmeh_rn@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
student
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Najmeh Rezaeinenezhad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street 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
City
تهران
Province
Tehran
Postal code
14398-13117
Phone
+98 21 6111 2871
Fax
Email
najmeh_rn@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of tehran
Full name of responsible person
Najmeh Rezaeinezhad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
Karegar
City
Tehran
Province
Tehran
Postal code
14398-13117
Phone
+98 21 6111 8820
Fax
Email
n.rezaeinezhad@ut.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Najmeh Rezaeinezhad
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
between 15th and 16th Streets, above Jalal Al Ahmad Intersection, North Kargar Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۴۶۶۱۹۱
Phone
+98 21 8835 1730
Email
najmeh_rn@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
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
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available