Trial reportThe oncologist2020
Effect of a Structured Teaching Module Including Intensive Prophylactic Measures on Reducing the Incidence of Capecitabine-Induced Hand-Foot Syndrome: Results of a Prospective Randomized Phase III Study.
Trial report in The oncologist, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled 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.
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.
Who cites it
8 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.
- Chemotherapy-related hand-foot syndrome and hand-foot skin reaction: a review of management and possible approaches for Asian patients by the Japanese pharmacist-led oncodermatology study team.International journal of clinical oncology · 2025Pooled it
- A phase II study evaluating the preventive effect of topical hydrocortisone for capecitabine-induced hand-foot syndrome in patients with colorectal cancer receiving adjuvant chemotherapy with capecitabine plus oxaliplatin (T-CRACC study).International journal of clinical oncology · 2025Trial
- Prophylactic Medium-Class Topical Steroids are Associated with a Lower Incidence of Capecitabine-Induced Hand-Foot Syndrome in Patients with Colorectal Cancer.Dermatology and therapy · 2026Article
- Preventive and Therapeutic Interventions for Anticancer Drug-induced Dermatologic Toxicities: a Scoping Review.Current oncology reports · 2026Article
- Nudge-based patient education by pharmacists to promote self-care behaviors for preventing and mitigating chemotherapy-induced skin toxicity: rationale, design, and study protocol of the PHARM-NUDGE trial.Journal of pharmaceutical health care and sciences · 2026Article
- A randomized, double-blind, placebo-controlled phase III study evaluating the preventive effect of diclofenac cream on capecitabine-related hand-foot syndrome: study protocol of J-SUPPORT2401/JORTC-SUP06 (J-DIRECT).International journal of clinical oncology · 2025Article
- Validation of 11 added items of the outpatient version of the Utrecht Symptom Diary in patients receiving chemotherapy or targeted therapy.Journal of patient-reported outcomes · 2024Observational
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
lessons learnedA structured teaching module including intensive prophylactic measures to alleviate hand-foot syndrome (HFS) during capecitabine therapy is feasible but ineffective at protecting patients from HFS. Pharmacologic therapeutic interventions should be investigated for the management of this complication.
backgroundCapecitabine-induced hand-foot syndrome (HFS) has a detrimental effect on quality of life. The effect of a structured teaching module including intensive prophylactic measures was evaluated.
methodsThis non-crossover phase III double-blinded clinical trial randomized patients in a 1:1 ratio to either a control group or to a group administered a structured teaching model including intensive prophylactic measures on HFS administered by a trained oncology nurse at regular intervals (case) versus standard information on HFS care administered by treating clinician (control). The primary endpoint was comparison of fraction of patients in both arms developing at least grade 2 HFS.
resultsBetween June 15, 2016, and April 4, 2018, 280 patients (140 to case and 140 to control) were enrolled. The median number of capecitabine chemotherapy cycles was eight; 269 patients (96%) were evaluable for HFS, of whom 89 patients (33.08%) developed at least grade 2 HFS (grade 2 HFS, 73 patients [26.1%]; grade 3 HFS, 16 patients (5.7%}). There was no difference in at least grade 2 HFS between evaluable case and control arms of the study (control group, 45/135 [33.3%]; case, 44/134 [32.8%]; p = .93).
conclusionThe use of a structured teaching module including intensive prophylactic measures was feasible, but this did not reduce the incidence and severity of capecitabine-induced HFS.
Indexed as
Identifiers
What OpenQuestion holds
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.