Breast CancerPhase 3NCT03518957
12-week Exercise Intervention Program Versus Observation in Early Stage Breast Cancer Patients on the Impact on Mental Health, Quality of Life and Immune Markers
A Phase 3 study testing Exercise in people with Breast Cancer, run by National University Hospital, Singapore at 3 sites in Singapore.
Trial summary
Exercise in early breast cancer patients has the potential to improve depression, anxiety, fatigue, quality of life and even survival. The effects of exercise may come about by way of changes in weight, immune markers and telomere length, but data on this so far has not been conclusive. Read more about this study
- Who is it for?
- Ages 21 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 3 sitesSingapore
- Study dates
- 12 Mar 2015to 20 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Age 21-70 years
- Histological or cytological diagnosis of breast carcinoma
- Stage I-III breast cancer
- Has undergone curative breast cancer surgery with no clinically measurable tumor
- Between 4-12 weeks from the last adjuvant radiotherapy or chemotherapy session, if given, whichever is later. Patients who do not receive adjuvant chemotherapy or radiotherapy can be enrolled and will be randomized within 4-12 weeks of breast cancer surgery.
- Able to sign informed consent
- Able to adhere to study procedures
Who cannot join
- Cardiovascular, respiratory, or musculoskeletal problems that preclude moderate physical activity
- Major medical problems deemed by the investigator to be unsuitable for enrollment
Trial locations and contacts
3 sites in 1 country.
Singapore3 sites, 3 recruiting
- Recruiting
National University Hospital, Singapore
Singapore, 119228
Soo Chin Lee, (65) 6779 5555, soo_chin_lee@nuhs.edu.sg
- Recruiting
Tan Tock Seng Hospital
Singapore, 308433
Ern Yu Tan, +65 6357 7807, Ern_Yu_Tan@ttsh.com.sg
Soon-U Lawrence Lee
- Recruiting
Ng Teng Fong General Hospital
Singapore, 609606
Chuan Chien Tan, +65 6716 2000, Chuan_Chien_Tan@nuhs.edu.sg
About this study
Official title: A Randomized Controlled Study of a 12-week Exercise Intervention Program Versus Observation in Early Stage Breast Cancer Patients on the Impact on Mental Health, Quality of Life and Immune Markers
Exercise in early breast cancer patients has the potential to improve depression, anxiety, fatigue, quality of life and even survival. The effects of exercise may come about by way of changes in weight, immune markers and telomere length, but data on this so far has not been conclusive. To better understand the physical, psychological, and biological effects of exercise on breast cancer survivorship, the investigators propose to perform a phase III randomized controlled trial of a 12-week exercise intervention program versus usual care in early stage breast cancer patients, and will follow up the patients prospectively for 5 years, with serial assessment of physical and functional activity, QoL, depression and anxiety scores, telomere length and plasma immune markers.
Read the detailed description
In this study, 304 eligible patients will be randomized 1:1 to a 12-week exercise intervention program versus observation, and stratified by two factors: received adjuvant chemotherapy versus not, and age<50 versus age ≥50 years.
Breast cancer and its treatment can have both physical and psychological sequelae, which can persist many years after diagnosis. Physical effects include higher rates of pain, fatigue and decline in physical function, while psychological effects include depression and anxiety. In particular, depression spectrum syndromes occur in 20-50% of people with cancer, and in 1.5-46% of people with breast cancer. In a recent study conducted locally at the National University Cancer Institute, Singapore (NCIS), it was found that 27% of newly diagnosed cancer patients have caseness for depression and 44% have caseness for anxiety, as measured using the Hospital Anxiety and Depression scale. Breast cancer is also associated with weight gain - as many as 50-96% of women, especially those undergoing chemotherapy, experience sarcopenic weight gain during treatment, in the range of 2.5-6.2kg. Patients do not tend to return to their pre-diagnosis weight. With respect to quality of life (QoL), poorer QoL occurs in the short term, whereas long-term survivors tend to have a good overall QoL, albeit with an increase in some specific problems like lymphoedema and sexual dysfunction. Some of these measures predict overall survival and risk of recurrence - low levels of psychological distress and low fatigue independently predicted longer recurrence-free and overall survival, and lack of anxiety predicted longer recurrence-free survival. Obesity is also a poor prognostic factor and increases the risk of recurrence.
Telomere length (TL), which generally shortens with ageing, may also be implicated - in a study of breast cancer patients with or without insomnia, those with insomnia were reported to have higher rates of depression, fatigue and anxiety, and shorter TLs. Furthermore, breast cancer patients who were engaged in at least moderate physical activity had significantly longer TLs than those who did not, although there was no correlation between depression and shorter TLs in this study.Another study in prostate cancer patients showed that 3 months of comprehensive lifestyle changes after diagnosis was associated with increased telomere lengths and reduced telomerase activity after 5 years of follow-up.
To better understand the physical, psychological, and biological effects of exercise on breast cancer survivorship, the investigators propose to perform a phase III randomized controlled trial of a 12-week exercise intervention program versus usual care in early stage breast cancer patients, and will follow up the patients prospectively for 5 years, with serial assessment of physical and functional activity, QoL, depression and anxiety scores, telomere length and plasma immune markers.
- Conditions
- Breast Cancer
- Being tested
- Exercise
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Week 1: Patients will undergo an introductory session where the occupational therapist will assess the general condition and physical fitness of the subjects.
Week 1 to Week 12: Group exercise sessions supervised by a physiotherapist, twice per week, each session lasting 1 hour, with no more than 8 participants in each group exercise session. The exercise regimen for each session will be personally tailored for the subjects, and will include stretching, cardiovascular and strength training, and cooling down exercises.
Week 12 onwards: Patients will receive phone calls- monthly for the first 6 months and then 3 monthly up to the 2-year mark, to encourage them to continue with their exercise regimen at home.
| Study group | Role | What they receive |
|---|---|---|
| Exercise intervention | Experimental | Patients who are randomised to this arm will be enrolled to the exercise programme. Receives: Behavioral: Exercise |
| Non-exercise | No intervention | Patients who are randomised to the non-exercise group can continue their daily and physical activities as they normally would. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved mental health
Based on the HADS (Hospital Anxiety and Depression Scale) questionnaire, we define a score of ≥8/21 as caseness for anxiety or depression
Measured: 12 months
Secondary outcomes (1)
Adherence rate
Subjects are considered to have adhered to the 12-week exercise regimen if they have completed at least 20 scheduled sessions over a period of no longer than 16 weeks
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start12 Mar 2015
- Primary completion20 Dec 2021 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518957
- Sponsor's protocol ID
- 2014/01283
- Other IDs
- 2014
- Status last verified
- Feb 2018
- First submitted
- 27 Mar 2018
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carayol M, Bernard P, Boiche J, Riou F, Mercier B, Cousson-Gelie F, Romain AJ, Delpierre C, Ninot G. Psychological effect of exercise in women with breast cancer receiving adjuvant therapy: what is the optimal dose needed? Ann Oncol. 2013 Feb;24(2):291-300. doi: 10.1093/annonc/mds342. Epub 2012 Oct 5.
PubMed 23041586Kolden GG, Strauman TJ, Ward A, Kuta J, Woods TE, Schneider KL, Heerey E, Sanborn L, Burt C, Millbrandt L, Kalin NH, Stewart JA, Mullen B. A pilot study of group exercise training (GET) for women with primary breast cancer: feasibility and health benefits. Psychooncology. 2002 Sep-Oct;11(5):447-56. doi: 10.1002/pon.591.
PubMed 12228878
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of a 12-week Exercise Intervention Program Versus Observation in Early Stage Breast Cancer Patients on the Impact on Mental Health, Quality of Life and Immune Markers
- ClinicalTrials.gov ID
- NCT03518957
- Acronym / sponsor ID
- 2014/01283
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 12 Mar 2015 (actual)
- Primary completion
- 20 Dec 2021 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 8 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Exercise in early breast cancer patients has the potential to improve depression, anxiety, fatigue, quality of life and even survival. The effects of exercise may come about by way of changes in weight, immune markers and telomere length, but data on this so far has not been conclusive. To better understand the physical, psychological, and biological effects of exercise on breast cancer survivorship, the investigators propose to perform a phase III randomized controlled trial of a 12-week exercise intervention program versus usual care in early stage breast cancer patients, and will follow up the patients prospectively for 5 years, with serial assessment of physical and functional activity, QoL, depression and anxiety scores, telomere length and plasma immune markers.
Detailed description
In this study, 304 eligible patients will be randomized 1:1 to a 12-week exercise intervention program versus observation, and stratified by two factors: received adjuvant chemotherapy versus not, and age<50 versus age ≥50 years.
Breast cancer and its treatment can have both physical and psychological sequelae, which can persist many years after diagnosis. Physical effects include higher rates of pain, fatigue and decline in physical function, while psychological effects include depression and anxiety. In particular, depression spectrum syndromes occur in 20-50% of people with cancer, and in 1.5-46% of people with breast cancer. In a recent study conducted locally at the National University Cancer Institute, Singapore (NCIS), it was found that 27% of newly diagnosed cancer patients have caseness for depression and 44% have caseness for anxiety, as measured using the Hospital Anxiety and Depression scale. Breast cancer is also associated with weight gain - as many as 50-96% of women, especially those undergoing chemotherapy, experience sarcopenic weight gain during treatment, in the range of 2.5-6.2kg. Patients do not tend to return to their pre-diagnosis weight. With respect to quality of life (QoL), poorer QoL occurs in the short term, whereas long-term survivors tend to have a good overall QoL, albeit with an increase in some specific problems like lymphoedema and sexual dysfunction. Some of these measures predict overall survival and risk of recurrence - low levels of psychological distress and low fatigue independently predicted longer recurrence-free and overall survival, and lack of anxiety predicted longer recurrence-free survival. Obesity is also a poor prognostic factor and increases the risk of recurrence.
Telomere length (TL), which generally shortens with ageing, may also be implicated - in a study of breast cancer patients with or without insomnia, those with insomnia were reported to have higher rates of depression, fatigue and anxiety, and shorter TLs. Furthermore, breast cancer patients who were engaged in at least moderate physical activity had significantly longer TLs than those who did not, although there was no correlation between depression and shorter TLs in this study.Another study in prostate cancer patients showed that 3 months of comprehensive lifestyle changes after diagnosis was associated with increased telomere lengths and reduced telomerase activity after 5 years of follow-up.
To better understand the physical, psychological, and biological effects of exercise on breast cancer survivorship, the investigators propose to perform a phase III randomized controlled trial of a 12-week exercise intervention program versus usual care in early stage breast cancer patients, and will follow up the patients prospectively for 5 years, with serial assessment of physical and functional activity, QoL, depression and anxiety scores, telomere length and plasma immune markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise intervention | Experimental | Behavioral: ExercisePatients who are randomised to this arm will be enrolled to the exercise programme. |
| Non-exercise | No intervention | –Patients who are randomised to the non-exercise group can continue their daily and physical activities as they normally would. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female
- Age 21-70 years
- Histological or cytological diagnosis of breast carcinoma
- Stage I-III breast cancer
- Has undergone curative breast cancer surgery with no clinically measurable tumor
Key exclusion criteria (2 listed)
- Cardiovascular, respiratory, or musculoskeletal problems that preclude moderate physical activity
- Major medical problems deemed by the investigator to be unsuitable for enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseWeek 1: Patients will undergo an introductory session where the occupational therapist will assess the general condition and physical fitness of the subjects. Week 1 to Week 12: Group exercise sessions supervised by a physiotherapist, twice per week, each session lasting 1 hour, with no more than 8 participants in each group exercise session. The exercise regimen for each session will be personally tailored for the subjects, and will include stretching, cardiovascular and strength training, and cooling down exercises. Week 12 onwards: Patients will receive phone calls- monthly for the first 6 months and then 3 monthly up to the 2-year mark, to encourage them to continue with their exercise regimen at home. | Behavioural | Exercise intervention |
Primary outcome
Improved mental health
Time frame: 12 months
Based on the HADS (Hospital Anxiety and Depression Scale) questionnaire, we define a score of ≥8/21 as caseness for anxiety or depression
1 secondary outcome
Adherence rate
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
- Background: PubMed 23041586Carayol M, Bernard P, Boiche J, Riou F, Mercier B, Cousson-Gelie F, Romain AJ, Delpierre C, Ninot G. Psychological effect of exercise in women with breast cancer receiving adjuvant therapy: what is the optimal dose needed? Ann Oncol. 2013 Feb;24(2):291-300. doi: 10.1093/annonc/mds342. Epub 2012 Oct 5.
- Background: PubMed 12228878Kolden GG, Strauman TJ, Ward A, Kuta J, Woods TE, Schneider KL, Heerey E, Sanborn L, Burt C, Millbrandt L, Kalin NH, Stewart JA, Mullen B. A pilot study of group exercise training (GET) for women with primary breast cancer: feasibility and health benefits. Psychooncology. 2002 Sep-Oct;11(5):447-56. doi: 10.1002/pon.591.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Exercise in people with Breast Cancer, run by National University Hospital, Singapore at 3 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Soo Chin Lee ((65) 6779 5555, soo_chin_lee@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved mental health (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03518957, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2018.