Breast Cancer Clinical Trial
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.
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.
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