Effect of add-on naldemedine treatment in patients with cancer and opioid-induced constipation insufficiently responding to magnesium oxide: a pooled, subgroup analysis of two randomized controlled trials.

What Was Tested

The paper reports a study of Vitamin D, K2, Magnesium and Zinc, published as a randomized controlled trial.

To evaluate the additive effect of naldemedine tosylate (naldemedine) on opioid-induced constipation in cancer patients insufficiently responding to magnesium oxide treatment.

Who Took Part

The abstract describes 116 patients taking part.

By PubMed's age tags, the people studied were adults, middle-aged adults and older adults, both men and women.

The researchers evaluated the effect and safety of naldemedine in 116 patients who received naldemedine in addition to magnesium oxide (naldemedine group) and 117 patients who received placebo in addition to magnesium oxide (placebo group).

Both groups included patients insufficiently responding to magnesium oxide for opioid-induced constipation.

How the Study Was Run

The design is described as randomized, double-blind and placebo-controlled.

Because people in this Vitamin D, K2, Magnesium and Zinc study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Neither the patients nor the staff measuring them knew who was on Vitamin D, K2, Magnesium and Zinc, so expectations could not easily colour the readings.

The comparison arm used a placebo, so changes seen with Vitamin D, K2, Magnesium and Zinc could be set against what happens without it.

The researchers combined two randomized, double-blind, placebo-controlled, phase IIb and III trials of naldemedine and conducted a post hoc subgroup analysis.

Effect was assessed using spontaneous bowel movement responder rate, complete spontaneous bowel movement responder rate, changes in spontaneous bowel movements and complete spontaneous bowel movements.

What Was Measured

The subject headings attached to it are Magnesium Oxide, Naltrexone, Neoplasms, Opioid-Induced Constipation, Analgesics, Opioid, Narcotic Antagonists and Constipation.

Author keywords: cancer management, clinical management, clinical trials, drug discovery and delivery and quality of life.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Vitamin D, K2, Magnesium and Zinc in 116 patients.

Results are reported in around 4 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2025 (Japanese journal of clinical oncology), a journal based in England.

More context: the Vitamin D, K2, Magnesium and Zinc compound page, all human trials.