Completed

Breast Cancer Research Centre – WA is a multidisciplinary breast cancer centre situated in Perth, Western Australia. We have previously reported results from our group that approximately 8% of patients with early or locally advanced breast cancer did not commence or complete treatment protocols recommended by the multidisciplinary group (Samarasinghe et al 2019).

To evaluate the feasibility, safety, and effectiveness of a structured, supervised 6-week exercise program in reducing fatigue in breast cancer patients, as measured by the FACIT-F questionnaire, with success defined as a ≥30% reduction in fatigue and a ≥3-point improvement in FACIT-F scores.

The study also aims to compare outcomes between participants following the supervised exercise program and those in a control group performing self-directed exercise.

The 50-minutes exercise program (EP) consisted of a supervised 10 minute warm-up on a treadmill or bicycle, aiming to increase the heart rate; followed by 30-minutes of resistance exercises involving upper and lower limbs and concluded with 10-minutes of stretching exercises. Patients participating in the EP were planned to undertake the program twice a week for 6 consecutive weeks.

We first conducted a non-randomised part 1 of the study, where all consenting patients underwent the exercise program to ensure that the program was feasible and safe. We determined that if at least 75% of patients were able to complete at least 80% of the 6-week program, without any significant side effects, then we would proceed to part 2 of the study. In Part 2, patients would be randomly allocated to EP (EP group), or serve as the control comparison group (Control group – where patients were able to do any exercise they wished at home).  Patients in both groups were to be seen weekly by BCRC-WA trial staff where QOL questionnaires were done by patients, and symptoms and vital signs were recorded.

Based on the medical literature, we anticipated that the EP would be considered successful if there was a at least a 30% lessening of fatigue. We needed at least 36 patients to be recruited (18 Control and 18 EP), where at least 75% of visits were attended by all patients and at least 75% of EP group completed the exercises. We used the FACIT-F questionnaire to assess for levels of fatigue – this is a proven research survey, where a 3-point score or more increase in the questionnaire score (from study commencement to completion at 6-weeks), is reflective of a significant lessening of fatigue.

The EP was feasible and safe, with 6 of 7 patients in part 1 able to complete more than three-quarters of the EP. In total, 44 patients were recruited into AREA, with 5 patients not being able to be included in the study analysis. Three patients withdrew consent and two only did EP once. The reason for all patients to withdraw was unrelated to any breast cancer or exercise issues. Thus, 18 Control and 22 EP patients were included for the analysis. There were no significant differences between the two groups in average age (61yrs Control, 56yrs EP). All other characteristics with respect to the proportion of those with secondaries in the bones, organs or soft tissues; those undergoing treatment with chemotherapy (± trastuzumab) or hormonal therapy and time since diagnosis of Mbc; were balanced and not statistically different between the two group.

Unfortunately, for reasons unrelated to cancer progression, only 33% of Control patients attended a minimum of 75% of study visits (compared to 86% of EP group completing EP and attending study visits). Thus, it was not statistically valid to compare the fatigue scores between the groups, as we had planned. However, it was encouraging to note that the percentage of patients reporting a significant lessening of their fatigue and QOL was higher in the EP group. In addition, questionnaires on their emotional well-being, functional well-being and overall quality of life also showed higher proportion of patients in the EP group reporting an improvement over the 6-week period (table below).

We have shown in this small study conducted at BCRC-WA that patients on treatment for MBC and who experienced fatigue are keen to be involved in research using exercise to lessen this debilitating symptom. The structured program designed by our collaborating physiotherapists is safe and feasible, with a large proportion of patients being able to complete the vast majority of the 12 exercise sessions over a 6-week period. Two-thirds of EP patients reported a significant improvement in fatigue QOL, as compared to less than half of the control patients. Finally, three other aspects of QOL (emotional, physical and general wellbeing) were reported as being improved during the course of the AREA study in a higher proportion of patients in the exercise program versus controls. We would encourage patients with MBC to be involved in a structured exercise program.

We thank all the patients for their participation in this study and hope they find the results helpful in managing this troublesome symptom of fatigue.