Evidence map›Paper›PMID 18182992›Full record

Trial reportBritish journal of cancer2008

Safety, tolerability and pharmacokinetics of intravenous ghrelin for cancer-related anorexia/cachexia: a randomised, placebo-controlled, double-blind, double-crossover study.

F Strasser, T A Lutz, M T Maeder, B Thuerlimann, D Bueche, M Tschöp, K Kaufmann, B Holst, M Brändle, R von Moos and 2 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of cancer, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00933361 (Individual Dose-escalated Bi-daily sc Ghrelin in Cancer Cachexia), which is not on this map. Cited by 60 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed, 5 pooled it
5.5field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00933361 phase1 / phase2completednot on this mapstarted 2009, after this paper: background citation

Individual Dose-escalated Bi-daily sc Ghrelin in Cancer Cachexia: a Phase I/II Study

TypeinterventionalSponsorCantonal Hospital of St. GallenRan2009 to 2011Enrolled21ConditionsAdvanced Cancer, CachexiaArmsghrelin
3 · Its place in the literature

Who cites it

60 citing papers in PubMed, 5 syntheses or guidelines pooled it, 160 citations in OpenAlex.

  1. Pooled it
  2. Ghrelin for the management of cachexia associated with cancer.The Cochrane database of systematic reviews · 2018
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. ROMANA 3: a phase 3 safety extension study of anamorelin in advanced non-small-cell lung cancer (NSCLC) patients with cachexia.Annals of oncology : official journal of the European Society for Medical Oncology · 2017
    Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Cancer cachexia: molecular basis and therapeutic advances.Signal transduction and targeted therapy · 2026
    Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. Review
  17. Review
  18. Review
  19. Diet-related interventions for cancer-associated cachexia.Journal of cancer research and clinical oncology · 2021
    Review
  20. Natural ghrelin in advanced cancer patients with cachexia, a case series.Journal of cachexia, sarcopenia and muscle · 2021
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 5 institutions in 3 countries.

F StrasserOncological Palliative Medicine, Division Oncology/Haematology, Department Internal Medicine and Palliative Care Center, Cantonal Hospital, Rorschacherstrasse, St Gallen 9007, Switzerland. florian.strasser@kssg.ch
T A Lutz
M T Maeder
B Thuerlimann
D Bueche
M Tschöp
K Kaufmann
B Holst
M Brändle
R von Moos
R Demmer
T Cerny
University of St. Gallen · CHUniversity of Zurich · CHUniversity Hospital of Basel · CHUniversity of Cincinnati · USUniversity of Copenhagen · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Twenty-one adult patients were randomised to receive ghrelin on days 1 and 8 and placebo on days 4 and 11 or vice versa, given intravenously over a 60-min period before lunch: 10 received 2 microg kg(-1) (lower-dose) ghrelin; 11 received 8 microg kg(-1) (upper-dose) ghrelin. Active and total ghrelin, growth hormone (GH), and insulin-like growth factor 1 levels were monitored at baseline (4-5 days before day 1), during treatment days, and at end of study (day 17/18). Drug-related adverse events (assessed by NCI-CTC-toxicity criteria and cardiac examination) did not differ between ghrelin and placebo. No grade 3/4 toxicity or stimulation of tumour growth was observed. The peak increase of GH, a biological marker of ghrelin action, was 25 ng ml(-1) with lower-dose and 42 ng ml(-1) with upper-dose ghrelin. Morning fasting total ghrelin levels were higher (P<0.05) for upper-dose patients at end of study (3580 pg ml(-1)) than at baseline (990 pg ml(-1)). Insulin-like growth factor 1 levels did not change. At day 8, 81% of patients preferred ghrelin to placebo as against 63% at the end of study. Nutritional intake and eating-related symptoms, measured to explore preliminary efficacy, did not differ between ghrelin and placebo. Ghrelin is well tolerated and safe in patients with advanced cancer. For safety, tolerance, and patients' preference for treatment, no difference was observed between the lower- and upper-dose group.

Indexed as

AgedAged, 80 and overAlgorithmsAnorexiaCachexiaCross-Over StudiesDouble-Blind MethodFemaleGhrelinHumansInfusions, IntravenousMaleMiddle AgedNeoplasmsPlacebosGhrelinPlacebos

Identifiers

PMID18182992
PMCPMC2361459
OpenAlexW2081246610

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.