Evidence map›Paper›PMID 26248652›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2016

MC11C4: a pilot randomized, placebo-controlled, double-blind study of venlafaxine to prevent oxaliplatin-induced neuropathy.

Collin Zimmerman, Pamela J Atherton, Deirdre Pachman, Drew Seisler, Nina Wagner-Johnston, Shaker Dakhil, Jacqueline M Lafky, Rui Qin, Axel Grothey, Charles L Loprinzi

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 3 pooled it
2.6field-weighted citation impact, top 9% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 3 syntheses or guidelines pooled it, 61 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Antidepressants for the treatment of depression in people with cancer.The Cochrane database of systematic reviews · 2018
    Pooled it
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Oxaliplatin-induced peripheral neuropathy: from pathogenesis to treatment.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Review
  9. Chemotherapy-induced peripheral neuropathy in breast cancer: a narrative review.Translational breast cancer research : a journal focusing on translational research in breast cancer · 2026
    Review
  10. Review
  11. Article
  12. Review
  13. Article
  14. Review
  15. Measuring symptoms and toxicities: a 35-year experience.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
    Review
  16. Antidepressants for the treatment of depression in people with cancer.The Cochrane database of systematic reviews · 2023
    Review
  17. Chemotherapy-Induced Peripheral Neuropathy.Handbook of experimental pharmacology · 2023
    Article
  18. Treatment and diagnosis of chemotherapy-induced peripheral neuropathy: An update.Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie · 2022
    Review
  19. Article
  20. 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

10 authors at 5 institutions in 1 country.

Collin ZimmermanMayo Clinic, 200 1st St SW, Rochester, MN, 55905, USA.
Pamela J AthertonAlliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.
Deirdre PachmanAlliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.
Drew SeislerAlliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.
Nina Wagner-JohnstonWashington University School of Medicine, St. Louis, MO, USA.
Shaker DakhilCancer Center of Kansas, Wichita, KS, USA.
Jacqueline M LafkyMayo Clinic, 200 1st St SW, Rochester, MN, 55905, USA.
Rui QinMayo Clinic, 200 1st St SW, Rochester, MN, 55905, USA.
Axel GrotheyMayo Clinic, 200 1st St SW, Rochester, MN, 55905, USA.
Charles L LoprinziMayo Clinic, 200 1st St SW, Rochester, MN, 55905, USA. cloprinzi@mayo.edu.
Mayo Clinic · USAlliance Data (United States) · USCancer Center of Kansas · USWashington University in St. Louis · USWinnMed · US

Funding

Women's Cancer ProgramP30CA015083 · NCI · MAYO CLINIC ROCHESTER · PI Felicity Enders · 1985 to 2026
$151.3M
SUPPLEMENTU10CA037404 · NCI · MAYO CLINIC ROCHESTER · PI LOPRINZI, CHARLES L · 1985 to 2014
$34.8M
RESEARCH BASE SUPPORT FOR COMMUNITY CLINICAL ONCOLOGY PRU10CA037447 · NCI · UNIVERSITY OF CHICAGO · PI BERTAGNOLLI, MONICA M, PASKETT, ELECTRA D. · 1985 to 2015
$25.3M
NCI NIH HHS CA037447NCI NIH HHS P30 CA015083NCI NIH HHS U10 CA037404NCI NIH HHS U10 CA037447
6 · The paper itself

Abstract

purposePrevious pilot data suggested that venlafaxine could prevent acute and chronic oxaliplatin-related neuropathy. The purpose of this randomized, placebo-controlled, double-blinded pilot study was to obtain additional data to support conducting a phase III trial to test the use of venlafaxine to prevent oxaliplatin neurotoxicity.

methodsFifty patients, scheduled to undergo oxaliplatin-based therapy (FOLFOX) for stages II-III (67%) or stage IV (33%) colon cancer, were randomized to receive venlafaxine extended release (37.5 mg) or placebo, twice daily, through their last dose of oxaliplatin and then titrated off. Neurotoxicity was evaluated via several patient- and physician-reported measures, including the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20 (EORTC QLQ-CIPN20) instrument.

resultsBaseline patient characteristics were equivalent for the two arms, with a median age of 60 years. There was a trend toward benefit for the venlafaxine arm, when evaluated by the oxaliplatin-specific neuropathy scale and by acute neuropathy measures of throat discomfort and discomfort swallowing cold liquids, the latter only for the first two oxaliplatin doses. These trends were outweighed by a lack of any such trends in all other measurements including the following: (1) the CIPN20 sensory subscale (P = 0.55, primary endpoint), physician-completed NCI CTCAE assessment, or cumulative administered oxaliplatin doses (median 716 vs 631 mg for placebo and venlafaxine, respectively, P = 0.34).

conclusionsThe present study neither supports the use of venlafaxine for preventing oxaliplatin-induced neuropathy in clinical practice nor the initiation of a phase III trial to investigate venlafaxine in this setting.

Indexed as

Double-Blind MethodFemaleHumansMaleMiddle AgedOrganoplatinum CompoundsOxaliplatinPeripheral Nervous System DiseasesPilot ProjectsQuality of LifeSerotonin and Noradrenaline Reuptake InhibitorsVenlafaxine HydrochlorideOrganoplatinum CompoundsOxaliplatinSerotonin and Noradrenaline Reuptake InhibitorsVenlafaxine HydrochlorideChemotherapy-induced neuropathy preventionVenlafaxine

Identifiers

PMID26248652
PMCPMC4939800
OpenAlexW1051008347

What OpenQuestion holds

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Registered trials

None linked

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.