Evidence map›Paper›PMID 26458923›Full record

Trial reportTrials2015

Rationale and design of the Adapted Physical Activity in advanced Pancreatic Cancer patients (APACaP) GERCOR (Groupe Coopérateur Multidisciplinaire en Oncologie) trial: study protocol for a randomized controlled trial.

Cindy Neuzillet, Mathieu Vergnault, Franck Bonnetain, Pascal Hammel

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02184663 (Multicenter, Randomized Study, Evaluation of Adapted Physical Activity Program in Patients With Unresectable, Locally Advanced or Metastatic Pancreatic Cancer), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 25% 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.

NCT02184663 naunknown statusnot on this map

Multicenter, Randomized Study, Evaluation of Adapted Physical Activity Program in Patients With Unresectable, Locally Advanced or Metastatic Pancreatic Cancer

TypeinterventionalSponsorGERCOR - Multidisciplinary Oncology Cooperative GroupRan2014 to 2023Enrolled313ConditionsUnresectable Locally Advanced Cancer, Metastatic Pancreatic CancerArmswithout APA program, APA program
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. A review of physical activity in pancreatic ductal adenocarcinoma: Epidemiology, intervention, animal models, and clinical trials.Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.] · 2022
    Review
  6. Variability and limitations in home-based exercise program descriptions in oncology: a scoping review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020
    Article
  7. Article
  8. Review
  9. Longitudinal assessment of the impact of adapted physical activity on upper limb disability and quality of life in breast cancer survivors from an Italian cohort.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2018
    Article
  10. Article
  11. 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

4 authors at 2 institutions in 1 country.

Cindy NeuzilletDigestive Oncology Department and UMR1149, Beaujon University Hospital, Hôpitaux Universitaires Paris Nord Val de Seine (HUPNVS), Assistance Publique-Hôpitaux de Paris (AP-HP), 92110, Clichy La Garenne, France. cindy.neuzillet@orange.fr.
Mathieu VergnaultVisio Activités Sportives Interactives (V@si SARL), 34270, Saint Mathieu de Tréviers, France. mathieu.vergnault@vas-i.fr.
Franck BonnetainMethodology and Quality of Life in Oncology unit (EA 3181) and Quality of Life and Cancer Clinical Research Platform, Besançon University Hospital, 25000, Besançon, France. franck.bonnetain@univ-fcomte.fr.
Pascal HammelDigestive Oncology Department and UMR1149, Beaujon University Hospital, Hôpitaux Universitaires Paris Nord Val de Seine (HUPNVS), Assistance Publique-Hôpitaux de Paris (AP-HP), 92110, Clichy La Garenne, France. pascal.hammel@bjn.aphp.fr.
Assistance Publique – Hôpitaux de Paris · FRMethodology and Quality of Life Unit in Oncology · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundExercise during chemotherapy is a promising strategy to reduce fatigue and improve health-related quality of life (HRQoL). It has been shown to be feasible and efficient in various cancers, including advanced-stage cancers. Effects of physical activity have never been explored in advanced pancreatic ductal adenocarcinoma (PDAC). We aim to evaluate the effects of an exercise intervention in this setting.

methodsThis randomized, national, multicenter, interventional study will examine the effectiveness of an unsupervised, home-based, 16-week adapted physical activity (APA) program. Specificities of advanced PDAC for the implementation of the APA program will be taken into account (healthy volunteer as physical activity partner instead of patient groups, nutritional management). The main inclusion criteria are: patients with histologically confirmed, unresectable PDAC; scheduled for chemotherapy; performance status 0-2; age ≥ 18; and physical activity partner. In total, 200 patients will be randomized into either the APA program (aerobic and resistance exercises) in addition to usual care (including chemotherapy at the investigator's choice), or usual care. The primary objective will be the effect on fatigue (Multidimensional Fatigue Inventory, MFI-20) and HRQoL (European Organization for Research and Treatment of Cancer-Quality of Life-C30 questionnaire, EORTC-QLQ-C30; co-primary endpoint) at week 16. As secondary objectives, the effects of the exercise intervention on pain, anxiety, depression, nutritional status, insulin resistance, tolerance of chemotherapy, survival, and adherence to the APA program will be evaluated. DISCUSSION: Patients with advanced PDAC are strongly affected by fatigue, and are thus likely to benefit from an exercise intervention. Moreover, exercise may have a potential beneficial effect on tumor outcome by reducing insulin resistance and insulin/insulin-like growth factor-1 (IGF-1) secretion. However, an exercise intervention may appear challenging due to multiple PDAC-related symptoms such as fatigue, depression, pain, and denutrition. We hypothesize that an APA program taking into account specific characteristics of PDAC may improve symptoms and HRQoL. If demonstrated to be feasible and effective, such APA programs will be systematically proposed to patients with advanced PDAC in addition to usual care.

trial registrationClinicalTrial.gov REGISTRATION NUMBER: NCT02184663 ; Registration date: 2 July 2014.

Indexed as

Resistance TrainingAntineoplastic AgentsCarcinoma, Pancreatic DuctalClinical ProtocolsFranceHealth StatusHumansPancreatic NeoplasmsProspective StudiesQuality of LifeResearch DesignRisk FactorsSurveys and QuestionnairesTime FactorsTreatment OutcomeAntineoplastic Agents

Identifiers

PMID26458923
PMCPMC4603729
OpenAlexW1911296871

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.