A 12-month supervised exercise and diet programme improved quality of life and fatigue in men on androgen deprivation therapy

Design

Multicentre randomised trial (5:4), open-label, 15 NHS trusts in England

Population

700 men with prostate cancer on androgen deprivation therapy, median age 71.6 years

Primary outcome

FACT-P and FACIT-F fatigue scores at 12 months

Effect

FACT-P +4.5 (97.232% CI 1.7 to 7.2; P = 0.0004); FACIT-F +1.9 (0.4 to 3.4)

STAMINA was a multicentre randomised trial in 15 NHS trusts in England. It assigned 700 men on androgen deprivation therapy (ADT) for prostate cancer, in a 5:4 ratio, to the STAMINA programme or to optimised usual care. The programme combined 12 months of supervised aerobic and resistance exercise, dietary advice, behavioural support and gym membership. Optimised usual care included clinician training, educational materials, behavioural prompts and safety-to-exercise checks. Participants knew their allocation.

At 12 months the programme was superior on cancer-specific quality of life (FACT-P adjusted mean difference 4.5, 97.232% CI 1.7 to 7.2; P = 0.0004) and on fatigue (FACIT-F difference 1.9, 0.4 to 3.4; P = 0.0068). Three intervention-related serious adverse events occurred, and all participants recovered; there were no treatment-related deaths. Outcome data were missing for 11% of the programme group and 19% of the usual care group.

The trial was open-label with patient-reported outcomes, and 97% of participants were White. National and international guidelines already recommend exercise during ADT; the new point is that an embedded programme delivered that benefit in routine NHS care. Supervised programmes and gyms are not widely available in many Indian centres, so the transferable message is to prescribe and follow up activity systematically.

• Advise and document exercise for every man starting ADT, not only those who ask.
• Aerobic plus resistance training, with dietary advice, was the combination tested.
• Screen for safety before exercise, as in the usual care arm.
• If supervised sessions are not available, arrange the best local alternative and review progress at each visit.

Why it matters

Guidelines have long recommended exercise during ADT, and this trial shows that implementing it in routine care works.

Don't overread it

The trial was open-label with self-reported outcomes and was conducted in the NHS, in a mostly White population, and it does not show an effect on cancer outcomes.

The statistics, in plain English

The FACT-P and FACIT-F differences are scale points, not percentages. Because the comparison was open-label and the outcomes were self-reported, some of the difference may reflect expectation as well as real benefit.

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