[HN Gopher] Administering immunotherapy in the morning seems to ...
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       Administering immunotherapy in the morning seems to matter. Why?
        
       Author : abhishaike
       Score  : 90 points
       Date   : 2025-06-08 16:18 UTC (6 hours ago)
        
 (HTM) web link (www.owlposting.com)
 (TXT) w3m dump (www.owlposting.com)
        
       | zevets wrote:
       | This is bad science. Patients schedule when they go to
       | immunotherapy appointments. People who go in the morning are
       | still working/doing things, where once you get _really_ sick, you
       | end up scheduling mid-day, because its such a hassle to do
       | anything at all.
        
         | vhanda wrote:
         | From the article -
         | 
         | > this paper was not a retrospective study of electronic health
         | records, it was a randomized clinical trial, which is the gold
         | standard. This means that we'll be forced to immediately throw
         | away our list of other obvious complaints against this paper.
         | Yes, healthier patients may come in the morning more often, but
         | randomization fixes that. Yes, patients with better support
         | systems may come in the morning more often, but randomization
         | fixes that. Yes, maybe morning nurses are fresher and more
         | alert, but, again, randomization fixes that.
        
           | tines wrote:
           | What does randomization mean in this context, and why does it
           | fix those problems?
        
             | NhanH wrote:
             | Patients are assigned the time for their visits. The time
             | itself is randomized
        
             | ajkjk wrote:
             | https://en.wikipedia.org/wiki/Randomized_controlled_trial
             | 
             | The same thing it means in every context: that (with enough
             | samples) you can control for confounders.
        
               | tines wrote:
               | Supposing that patients did better in the morning
               | because, say, the nurses were more alert, no matter how
               | many samples you take you'll find the patients do better
               | in the morning. How does "more samples" help control for
               | confounders rather than just confirm a bias?
        
               | JumpCrisscross wrote:
               | > _How does "more samples" help control for confounders
               | rather than just confirm a bias?_
               | 
               | I think you're correct that randomising patient
               | assignments doesn't control for provider-side
               | confounders. Curious if the study also randomised nursing
               | assignments.
        
               | ajkjk wrote:
               | "more samples" is not what controls for confounders.
               | Controlling for confounders is what controls for
               | confounders, which you can only do with enough samples
               | that you can randomize out the effect of the confounder.
               | 
               | Whether or not they controlled for nurse-alertness is
               | something you'd have to read the paper (or assume the
               | researchers are intelligent) for.
        
               | tines wrote:
               | I guess I'm asking, how do you randomize out the
               | confounder in this case.
        
               | ajkjk wrote:
               | I imagine that that particular confounder is not possible
               | to eliminate via randomization. Perhaps you collect a
               | bunch of data on nurse awakeness--day shift vs night-
               | shift, measuring alertness somehow, or measuring them on
               | other activities known to be influenced by alertness--and
               | then ensure your results don't correlate with that.
               | 
               | There is also the mechanistic side: if you have lots of
               | plausible mechanism for what's going on, and you can
               | detect indicators for it that don't seem to correlate
               | with nurse alertness, that's a vote against it mattering.
               | Same if you have of lots of expertise on the ground and
               | they can attest that nurse alertness doesn't seem to have
               | an affect. There are lots of ways, basically, to reach
               | pretty good confidence about that, but they might not be
               | as rigorous as randomized assignments can be.
        
             | kelnos wrote:
             | Patients in the study are randomly assigned to the early
             | group or the late group. They don't get to schedule their
             | own appointments for whatever time of day they want.
        
               | tines wrote:
               | How does this control for the "alert nurses" variable? In
               | that case, patients would do better in the morning,
               | regardless of the patient.
        
               | anigbrowl wrote:
               | Why would you assume nurses are scheduled on a 9-5 basis?
        
               | simmerup wrote:
               | Why do you think you're going to poke holes in a research
               | article when you've clearly only just heard of the
               | concept and havent even read the article
        
               | tines wrote:
               | If I thought I could poke holes in the research, I
               | wouldn't be posting on HN. I'm asking questions to learn
               | because obviously I don't understand :)
        
               | d_tr wrote:
               | Based on these graphs and the differences in outcomes
               | they show, you are not talking about "alert vs less
               | alert" nurses but about "nurses doing their job vs nurses
               | basically slowly killing dozens of patients".
        
           | leereeves wrote:
           | > Yes, maybe morning nurses are fresher and more alert, but,
           | again, randomization fixes that
           | 
           | How does randomization fix that?
        
             | finnh wrote:
             | exactly. that one clause casts doubt on all the other
             | reasoning; randomization controls for patient selection
             | bias but not diurnal clinic performance
        
           | gus_massa wrote:
           | How many dose this treatment has? How many between them?
           | 
           | How many patients dropped out? (Or requested a schedule
           | change) Do they count like live or dead?
        
         | majormajor wrote:
         | I always have seen mid-day appointments as also a _luxury_ for
         | those doing well (at least professionally /financially). If you
         | have to go first thing in the morning, it's often because your
         | boss wants you in relatively early and won't let you take time
         | mid-day. If you're in a position where you can go in at 2PM and
         | _not_ have to sacrifice sleep to do so, that feels healthier.
         | 
         | Given the highly-evident strong circular nature of the body, a
         | hypothesis that it has something to do with that seems highly
         | likely, certainly worth following up on.
        
           | detourdog wrote:
           | I can schedule appointments whenever I want. I'm an early
           | riser and prefer my appointments first thing in the morning.
        
           | JumpCrisscross wrote:
           | > _mid-day appointments as also a luxury for those doing
           | well_
           | 
           | Irrelevant to this study given randomization.
        
           | pbhjpbhj wrote:
           | Surely your boss legally has to let you attend a health
           | appointment? Though they might not have to pay you. That
           | seems like a very basic workers right, the sort of thing
           | you'd have a general strike over if it didn't exist??
        
             | mjevans wrote:
             | The most vulnerable, at least among those who have a job at
             | least, often have the most draconian restrictions on when
             | and what they can do.
             | 
             | Believe they are being treated like robots. Maybe even
             | literally like gears rented by the hour, not even robots.
        
         | munchler wrote:
         | The appointment schedule was randomized, so your objection is
         | incorrect.
        
         | abhishaike wrote:
         | Writer of the article here: randomization fixes most of this,
         | but the other commenters are correct in that doesnt fully
         | account for the clinic performance (e.g. nurse performance,
         | which does dip during the night according to the literature). I
         | previously thought it wasn't a major issue for clinical trials,
         | since a separate team independent from the main ward are giving
         | the drugs, but there isn't super strong evidence to support
         | that. I will update the article to admit this!
         | 
         | This said, I am inclined to believe that this isn't a major
         | concern for chronotherapy studies, since I haven't yet seen it
         | being raised in any paper yet as a concern and the results seem
         | far too strong to blame entirely on 'night nurses make more
         | mistakes'. Fully possible that that is the case! I just am on
         | the other side of it
        
       | rendaw wrote:
       | I'm doing CedarCure. You're required to not exercise or
       | bath/shower for 2h after taking, which is fairly difficult in the
       | morning, so I asked the doc if I could do it in the evening
       | instead (despite explicit instructions to do it in the morning).
       | The doc said it was fine, confirmed by the pharmacist.
       | 
       | I should know better by now than to trust doctors to act based on
       | research and not gut feeling, but I hope this doesn't mean the
       | last year of taking it was a wash...
        
         | detourdog wrote:
         | I looked up CedarCure and what I found is that it is a
         | pesticide. What is the treatment about?
        
           | rendaw wrote:
           | It's an immunotherapy drug for cedar pollen allergy.
        
           | iamtheworstdev wrote:
           | looks like a sublingual immunotherapy treatment for allergies
           | to japanese cedar pollen.
        
           | tines wrote:
           | OP is an insect going in for assisted suicide.
        
           | annoyingnoob wrote:
           | https://synapse.inc/medicine/9101/
        
         | justsomehnguy wrote:
         | There is always an option what taking it in the evening is
         | magnitudes better than not taking it in the morning at all
         | because you skipped it because you need a shower.
         | 
         | Always remember what you are just an another patient with your
         | own quirks.
        
           | tialaramex wrote:
           | For the drug I take every day (Levothyroxine), research found
           | that evening was worse, but the explanation was poor
           | compliance - people forget to do it more often compared to
           | the morning. Same reason the contraceptive pill is less
           | effective than you'd expect in real populations, compliance
           | is poor. If you're the sort of person who can actually take
           | it on time, every day, without fail, it's extremely
           | effective, if you aren't, not so much. The choice to include
           | "dummy" pills is because of improved compliance - remembering
           | to take it every single day on the same schedule is just
           | easier, so adjust the medication not the instructions.
        
             | pbhjpbhj wrote:
             | What annoys me here is that these things are hidden - if
             | the patient knows that compliance is better (ie their
             | chance of staying with the medicine and so of getting
             | better) does it really reduce said compliance?
        
         | iamtheworstdev wrote:
         | a brand new study comes out and you're mad the doctors didn't
         | know about it a year ago?
         | 
         | do you carry any of the blame on yourself since you knew there
         | were explicit instructions but apparently waiting to shower or
         | exercise was too much of an inconvenience for you?
        
           | tomcam wrote:
           | Where did they say they're mad?
        
             | unaindz wrote:
             | The last paragraph heavily implies it
        
             | bjornasm wrote:
             | They explicitly fault the doctor for not acting on research
             | that wasn't available.
        
         | mjevans wrote:
         | Explicitly clear, but otherwise not overly specific, medication
         | instructions would be best.
         | 
         | Say exactly what matters.
         | 
         | E.G. 'Take once a day at a similar time.' VS overly specific
         | but not required 'take in the morning / evening / lunch / some
         | other assumption that doesn't matter.' HOWEVER maybe "Take once
         | a day with your first (full) meal." OR "Take once a day with
         | your primary meal." might make more sense for medications that
         | interact with food.
        
         | Nevermark wrote:
         | > I could do it in the evening instead (despite explicit
         | instructions to do it in the morning)
         | 
         | Have either you or your doctor identified the reason for the
         | morning recommendation?
         | 
         | Maybe restart consideration of timing there?
         | 
         | Doctors are going to take your practical need to break one part
         | of protocol, to maintain the rest of the protocol, seriously.
         | They can't resolve the practicalities of patients' lives.
        
       | jmward01 wrote:
       | I wonder if other basic processes could be at play here like when
       | patients go to the bathroom. If you do this in the morning they
       | may be more likely to not need that for a while while in the
       | evening they may do that immediately. I'm not saying this is the
       | mechanism, just pointing out that there are a lot of timing
       | dependent things in a person's schedule that could be a factor
       | here. It is a great thing to point out though. I hope a lot more
       | research goes into the idea of timing and integrating medication
       | into a schedule most effectively.
        
       | unnamed76ri wrote:
       | I used to be on a chemo drug and had to take folic acid every day
       | to stop it from doing bad things to me.
       | 
       | I had awful ulcers in my mouth from the chemo drug and had been
       | taking the folic acid in the morning. Through forgetfulness I
       | ended up shifting the folic acid to the afternoon and the ulcers
       | went away and never came back.
        
         | tomcam wrote:
         | Thanks for sharing, and I'm very glad you are here to discuss
         | it.
        
       | Laaas wrote:
       | Light affects us deeply. Very probably true for more than
       | immunotherapy.
        
       | NotGMan wrote:
       | Perhaps it's due to overnight fasting, that people in the morning
       | don't eat yet/as much?
       | 
       | Autophagy is increased during fasting, it usually takes 3 days of
       | water fasting to fully ramp up to its maximum, so no food
       | overnight might just slightly start it up.
       | 
       | I watched a youtube video of guy who did low carb and fasted at
       | least 24h before and after chemo (or even 48h, forgot which) and
       | he didn't experience the negative side effects of chemo as much.
        
       | levocardia wrote:
       | Hazard ratio of 0.45 seems implausibly high, especially when it's
       | just the exact same treatment dichotomized to before/after 3pm.
       | My money is on something other than a real circadian effect:
       | either the result of a 'fishing expedition' in the data, or some
       | other variable that incidentally varies by time of day. Maybe
       | breaking randomization, leaving the drugs out for too long at
       | room temp, etc. If you really believe this is an important and
       | biologically plausible effect it should be a top candidate for a
       | replication attempt.
        
         | trhway wrote:
         | >some other variable that incidentally varies by time of day.
         | 
         | glucose level? low in the morning, and cancer likes glucose
         | (among other effects of low glucose a cancer site would
         | probably have lower local acidity, and the high local acidity
         | is one of the tools used by cancer to protect and spread
         | itself) .
        
       | egocodedinsol wrote:
       | Here's a link to the abstract:
       | https://ascopubs.org/doi/abs/10.1200/JCO.2025.43.16_suppl.85...
       | 
       | apparently it was prospective and randomized. I'm a little
       | shocked by the effect size.
        
         | munchler wrote:
         | This paper was not a retrospective analysis, it was a
         | randomized clinical trial.
        
           | egocodedinsol wrote:
           | Yeah I'm checking - I saw several other oncologists
           | suggesting song a separate discussion.
        
       | raylad wrote:
       | My father was on chemotherapy with fludarabine, a dna base
       | analog. The way it functions is that it is used in DNA
       | replication, but then doesn't work, and the daughter cells die.
       | 
       | Typically, patients who get this drug experience a lot of adverse
       | effects, including a highly suppressed immune system and risk of
       | serious infections.
       | 
       | I researched whether there was a circadian rhythm in replication
       | of either the cancer cells or the immune cells: lymphocyte and
       | other progenitors, and found papers indicating that the cancer
       | cells replicated continuously, but the progenitor cells
       | replicated primarily during the day.
       | 
       | Based on this, we arranged for him to get the chemotherapy
       | infusion in the evening, which took some doing, and the result
       | was that his immune system was not suppressed in the subsequent
       | rounds of chemo given using that schedule.
       | 
       | His doctor was very impressed, but said that since there was no
       | clinical study, and it was inconvenient to do this, they would
       | not be changing their protocol for other patients.
       | 
       | This was around 1995.
        
         | sixo wrote:
         | Amazing. And shameful (for them.)
        
           | ch4s3 wrote:
           | It's not shameful, it's how evidence based medicine works.
           | One case is interesting but not a basis for changing a
           | protocol by itself. Tons of things could have influenced the
           | outcome and you need a proper study to know that.
        
             | wyldfire wrote:
             | Though it could certainly inspire such a study.
        
               | ch4s3 wrote:
               | Sure, but someone needs to fund, organize, and conduct
               | the study. If you're not at a research hospital it's not
               | as easy for a one off case to generate a study.
        
               | vlovich123 wrote:
               | This is a fairly innocuous change the doctor should be
               | organizing on their own to publish a pilot study. In
               | terms of funding very little would be required since
               | you're just making a small adjustment to when an existing
               | drug regimen is happening which you already isn't a
               | controlled factor requiring FDA oversight or anything.
        
               | _qua wrote:
               | Even simple studies are expensive and difficult. You need
               | IRB approval, data collection and organization, staff to
               | do those things. It seems simple from the outside but
               | making it happen takes time, effort, and money which then
               | means also applying for grants which is a process in and
               | of itself.
        
           | vkou wrote:
           | > And shameful (for them.)
           | 
           | 1. A single positive outcome with N=1 should generally not be
           | the basis for making a medical recommendation.
           | 
           | 2. It takes a mountain of research work to go from that to a
           | study that you _can_ draw meaningful conclusions from.
           | 
           | 3. The hospital is not in the business of doing research,
           | it's in the business of treating patients.
        
             | tilne wrote:
             | Regarding 3: Shouldn't the medical system be optimizing for
             | patient outcomes rather than the business their in?
             | 
             | Regarding the first two: I think the anecdote being from
             | 1995 suggests there would have been time to put together
             | said mountain of research.
             | 
             | I'm not agreeing that this is shameful for the original
             | doctor, but I do think it's shameful if avenues for
             | potential research are not taken because it's inconvenient
             | for the hospitals.
        
             | vlovich123 wrote:
             | I agree n=1 generally isn't enough, but something like this
             | is easily something you ask for volunteers for as an
             | experiment. There's 0 risk, you're taking the same drug.
             | The only reason a given time is selected anyway is for
             | administrative ease not because there's medical
             | requirements.
        
       | BDGC wrote:
       | If you're interested in circadian biology, which underlies
       | chronoimmunotherapy, please check out UCSD's BioClock Studio. We
       | create tutorial videos and other media to teach circadian biology
       | concepts: https://bioclock.ucsd.edu/
        
       | owenthejumper wrote:
       | Sicker patients get emergency treatment in the hospital in the
       | afternoon while healthier ones in the morning in the clinic
        
       | georgeburdell wrote:
       | Not a medical doctor. Does this also have implications for other
       | immunotherapy like allergy shots?
        
       | parsabg wrote:
       | I wonder if the same would also be true for immunosuppressants
       | administered for autoimmune conditions. Given they mostly
       | interact with the signaling pathways, I guess in theory they
       | should also be more effective in the morning if there is more
       | immune cell activity going on.
        
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