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STAMINA lifestyle intervention improves FACT-P and FACIT-F scores in men on ADTSupervised exercise improves quality of life for prostate cancer patients

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Key Takeaway
Consider a supervised exercise and dietary intervention to improve quality of life and fatigue in patients on ADT.

This randomized controlled trial enrolled 700 men with prostate cancer undergoing androgen deprivation therapy (ADT) across 15 UK National Health Service trusts. Participants were allocated to either the STAMINA lifestyle intervention or Optimised Usual Care. The STAMINA group received supervised aerobic and resistance exercise for 12 months, dietary advice, behavioral support, and a gym membership. The control group received clinician training, educational materials, and behavioral prompts.

At 12 months, the STAMINA group showed statistically significant improvements in quality of life and fatigue measures. The FACT-P score showed an adjusted mean difference of 4.5 (97.232% CI 1.7-7.2; p=0.0004). The FACIT-F score showed an improvement of 1.9 (0.4-3.4; p=0.0068) compared to Optimised Usual Care.

Safety data reported 3 intervention-related serious adverse events in the STAMINA group, including transient loss of consciousness, leg pain or weakness, and back pain. All participants recovered from these events, and no treatment-related deaths occurred. While the study provides a basis for prescribing supervised exercise and dietary advice to mitigate ADT effects, it is a single multicentre trial.

How this fits prior evidence

How this fits prior evidence: This finding addresses a gap in managing the side effects of androgen deprivation therapy (ADT). While previous evidence noted that ADT is associated with an OR 1.34 for acute kidney injury, this study focuses on improving quality of life and fatigue through lifestyle interventions. It complements the use of apalutamide plus ADT for improved pathological response and metastasis-free survival by offering a non-pharmacological approach to manage the systemic impacts of ADT.

Living with prostate cancer often involves hormone therapy, which can take a heavy toll on a man's daily life and energy levels. Researchers wanted to see if a structured lifestyle program could help patients feel better while undergoing this treatment.

In a trial involving 700 men across 15 health centers in England, one group received the STAMINA program. This included 12 months of supervised aerobic and resistance exercise, dietary advice, and behavioral support. The other group received optimized usual care, which included educational materials and safety checks.

After one year, the men in the STAMINA group reported better overall quality of life and significantly lower fatigue levels compared to those in the usual care group. While there were a few reports of minor issues like back pain or leg weakness, all patients recovered from these events. The results suggest that a guided exercise program is a practical way to help men manage the side effects of their treatment.

What this means for you:
Supervised exercise and dietary support can improve quality of life and reduce fatigue for men with prostate cancer.

Common questions

What kind of exercise was used in the study?

The STAMINA program provided 12 months of supervised aerobic and resistance exercise. This was combined with dietary advice and behavioral support to help men manage their health while undergoing hormone therapy for prostate cancer.

Did the exercise program help with fatigue?

Yes, the study found that the supervised exercise group had significantly better scores on the fatigue scale compared to the group receiving standard care. This suggests the program helps men feel less tired during their treatment.

Is the exercise program safe for men with prostate cancer?

The study reported three minor adverse events, including back pain and leg weakness. However, all participants recovered from these issues, and no deaths occurred. You should talk to your doctor about the best exercise plan for your specific needs.

Study Details

Study typeRct
Sample sizen = 389
EvidenceLevel 2
Follow-up12.0 mo
PublishedOct 2026
View Original Abstract ↓
BACKGROUND: Androgen deprivation therapy (ADT) for prostate cancer causes substantial adverse effects. Despite consistent national and international guideline recommendations, supervised exercise is rarely integrated into care. We aimed to determine whether the STAMINA lifestyle intervention, embedded into cancer care, would improve cancer-specific quality of life and fatigue versus behaviourally Optimised Usual Care in men with prostate cancer in England. METHODS: STAMINA was a multicentre, randomised trial done across 15 UK National Health Service (NHS) trusts in England. Men on ADT for prostate cancer were eligible. Participants were randomly assigned (5:4) via computer-generated minimisation, stratified by age, ADT duration, chemotherapy or androgen receptor pathway inhibitor therapy, and radiotherapy, to the STAMINA lifestyle intervention or to Optimised Usual Care. Participants were aware of treatment allocation. The STAMINA lifestyle intervention comprised supervised aerobic and resistance exercise for 12 months, dietary advice, behavioural support, and complimentary gym membership. Optimised Usual Care comprised clinician training, educational materials, behavioural prompts, and safety-to-exercise checks. Primary outcomes were the Functional Assessment of Cancer Therapy-prostate (FACT-P) and the Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) subscale at 12 months, analysed by intention to treat (according to randomised treatment). This trial is registered with ISRCTN (ISRCTN46385239), and recruitment is complete. FINDINGS: Between Jan 20, 2022, and June 12, 2023, 700 men were randomly assigned to STAMINA lifestyle intervention (n=389) or Optimised Usual Care (n=311). Median age was 71·6 years (IQR 66·3-76·0), and 680 (97%) of 700 participants were White. Primary outcome data were available for 345 (89%) of 389 participants in the STAMINA lifestyle intervention group and 251 (81%) of 311 in the Optimised Usual Care group. The STAMINA lifestyle intervention was superior to Optimised Usual Care in terms of FACT-P score (adjusted mean difference 4·5, 97·232% CI 1·7-7·2; p=0·0004) and FACIT-F score (1·9, 0·4-3·4; p=0·0068). Three intervention-related serious adverse events occurred in the STAMINA lifestyle intervention group (transient loss of consciousness, leg pain or weakness, and back pain); all participants recovered. No treatment-related deaths occurred. INTERPRETATION: The STAMINA lifestyle intervention meets best practice guidelines, can be implemented in NHS trusts in England, and offers clinicians a clear basis for identification and prescription of a supervised exercise and dietary advice intervention to mitigate negative effects associated with ADT. FUNDING: National Institute for Health Research.
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