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Low-dose olanzapine for cancer anorexia (Tata Memorial)

A randomised trial in India of a 2.5 mg dose of a decades-old, very cheap tablet. Six in ten patients gained more than 5% of their weight, against one in ten on placebo.

124 patients were randomised, double-blind. The primary endpoint, weight gain over 5% at 12 weeks, was achieved by 60% of patients on olanzapine vs 9% on placebo; appetite improved (visual analogue scale) in 43% vs 13%, and quality of life and chemotherapy toxicity scores favoured olanzapine. Adverse events were minimal at this dose (no excess sedation or metabolic effects over 12 weeks). The trial led ASCO to list low-dose olanzapine as an option in its 2024 cachexia guideline update. It is small, single-centre and short, and did not measure lean mass or survival; a multi-country replication is the obvious next step. Its significance is access: olanzapine is on the WHO essential medicines list and costs a few cents a day.

Setting
Untreated, locally advanced or metastatic gastric, hepatopancreaticobiliary or lung cancer starting chemotherapy: olanzapine 2.5 mg daily vs placebo for 12 weeks, plus standard nutritional advice
Phase
Phase 3
Sponsor
Tata Memorial Centre
Headline result
Weight gain over 5%: 60% vs 9%; appetite improvement 43% vs 13%.
Reported
2023
Enrolled
124
Replication
Not yet replicated; consistent with olanzapine's antiemetic trials and with an earlier small Indian randomised trial with megestrol.

Outcomes

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In plain words
What these results mean for people, not percentages
124 people took part
Weight gain greater than 5% at 12 weeksprimaryother endpoint
  • 60 vs 9 out of 100 reached this endpoint with Olanzapine 2.5 mg compared with Placebo; 51 more per 100.
  • Roughly one extra person helped for every 2 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
  • The p-value (<0.001) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
  • This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
  • These results apply to the people the trial enrolled: Untreated, locally advanced or metastatic gastric, hepatopancreaticobiliary or lung cancer starting chemotherapy: olanzapine 2.5 mg daily vs placebo for 12 weeks, plus standard nutritional advice. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

124 participants enrolled.

Weight gain greater than 5% at 12 weeksprimary
· p <0.001
Olanzapine 2.5 mg60 of 100
n = 63
Placebo9 of 100
n = 61
Source
EndpointArmnValueHR (95% CI)pSource
Weight gain greater than 5% at 12 weeksprimaryOlanzapine 2.5 mg6360%<0.001link
Placebo619%
Replication
Not yet replicated; consistent with olanzapine's antiemetic trials and with an earlier small Indian randomised trial with megestrol.

Connected

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