NCT07116161 Exercise Therapy and Cognitive Behavioural Therapy for Fatigue in Female Cancer Patients in Singapore
| NCT ID | NCT07116161 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Cancer Centre, Singapore |
| Condition | Fatigue |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-07-14 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-07-14 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this research study is to investigate the acceptability, feasibility, and effectiveness of exercise therapy and cognitive behavioral therapy (CBT) in improving fatigue levels and breast cancer treatment adherence in breast cancer patients.
Eligibility Criteria
Inclusion Criteria: Primary cohort (N=90): 1. Female 2. ≥21 years of age 3. Stage I-III breast cancer regardless of hormone receptor status or human epidermal growth factor receptor 2 (HER2) status 4. Completed surgery 5. Completed adjuvant chemotherapy, if indicated 6. Reported fatigue (One-item fatigue scale score ≥ 4) 7. Ability to read and communicate in English 8. Willing to provide informed consent for the study participation Exploratory cohort (N=10): 1. Female 2. ≥21 years of age 3. Stage IV breast cancer regardless of hormone receptor status or human epidermal growth factor receptor 2 (HER2) status 4. Completed surgery 5. Currently receiving systemic therapy (e.g. endocrine therapy, chemotherapy, targeted therapy or immunotherapy) 6. Reported fatigue (One-item fatigue scale score ≥ 4) 7. Ability to read and communicate in English 8. Willing to provide informed consent for the study participation Exclusion Criteria for both cohorts: 1. Pregnant or lactating 2. Presence of dementia or major psychiatric disease 3. Deemed medically unsuitable by medical team for low to moderate intensity exercise 4. Unable or unwilling for tele-counselling sessions 5. Uncontrolled pain or undiagnosed pain 6. Low blood counts: Hb \<8.0, Platelet \<50K, ANC \<1 7. Electrolyte imbalances: K \<3.0, Na \<130 8. Cardiovascular diseases, including but not limited to: LVEF \<35%, uncontrolled arrhythmias, severe coronary artery disease, severe valvular heart disease, uncontrolled hypertension etc. not cleared by a cardiologist 9. Active infection 10. Currently engaged in moderate to vigorous physical activity
Contact & Investigator
Dr Ryan Shea YC TAN, MBBS, MRCP(UK), MMed
PRINCIPAL INVESTIGATOR
National Cancer Centre, Singapore
Frequently Asked Questions
Who can join the NCT07116161 clinical trial?
This trial is open to female participants only, aged 21 Years or older, studying Fatigue. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07116161 currently recruiting?
Yes, NCT07116161 is actively recruiting participants. Contact the research team at ryan.shea.tan.y.c@singhealth.com.sg for enrollment information.
Where is the NCT07116161 trial being conducted?
This trial is being conducted at Singapore, Singapore, Singapore, Singapore, Singapore, Singapore, Singapore, Singapore.
Who is sponsoring the NCT07116161 clinical trial?
NCT07116161 is sponsored by National Cancer Centre, Singapore. The principal investigator is Dr Ryan Shea YC TAN, MBBS, MRCP(UK), MMed at National Cancer Centre, Singapore. The trial plans to enroll 100 participants.