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Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

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

Authors: Cindy Neuzillet, Mathieu Vergnault, Franck Bonnetain, Pascal Hammel

Published in: Trials | Issue 1/2015

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Abstract

Background

Exercise 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.

Methods

This 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 registration

ClinicalTrial.gov Registration number: NCT02184663; Registration date: 2 July 2014.
Appendix
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Literature
1.
2.
Harriss DJ, Atkinson G, Batterham A, George K, Cable NT, Reilly T, et al. Lifestyle factors and colorectal cancer risk (2): a systematic review and meta-analysis of associations with leisure-time physical activity. Colorectal Dis. 2009;11:689–701.CrossRefPubMed
3.
Friedenreich CM, Cust AE. Physical activity and breast cancer risk: impact of timing, type and dose of activity and population subgroup effects. Br J Sports Med. 2008;42:636–47.CrossRefPubMed
4.
Moore SC, Gierach GL, Schatzkin A, Matthews CE. Physical activity, sedentary behaviours, and the prevention of endometrial cancer. Br J Cancer. 2010;103:933–8.CrossRefPubMedPubMedCentral
5.
Mustian KM, Sprod LK, Palesh OG, Peppone LJ, Janelsins MC, Mohile SG, et al. Exercise for the management of side effects and quality of life among cancer survivors. Curr Sports Med Rep. 2009;8:325–30.CrossRefPubMedPubMedCentral
6.
Speck RM, Courneya KS, Masse LC, Duval S, Schmitz KH. An update of controlled physical activity trials in cancer survivors: a systematic review and meta-analysis. J Cancer Surviv. 2010;4:87–100.CrossRefPubMed
7.
Mishra SI, Scherer RW, Snyder C, Geigle PM, Berlanstein DR, Topaloglu O. Exercise interventions on health-related quality of life for people with cancer during active treatment. Cochrane Database Syst Rev. 2012;8:CD008465.PubMed
8.
Cramp F, Byron-Daniel J. Exercise for the management of cancer-related fatigue in adults. Cochrane Database Syst Rev. 2012;11:CD006145.PubMed
9.
10.
Velthuis MJ, Agasi-Idenburg SC, Aufdemkampe G, Wittink HM. The effect of physical exercise on cancer-related fatigue during cancer treatment: a meta-analysis of randomised controlled trials. Clin Oncol (R Coll Radiol). 2010;22:208–21.CrossRefPubMed
11.
Minton O, Richardson A, Sharpe M, Hotopf M, Stone P. Drug therapy for the management of cancer-related fatigue. Cochrane Database Syst Rev 2010; CD006704.
12.
Courneya KS, Segal RJ, Mackey JR, Gelmon K, Reid RD, Friedenreich CM, et al. Effects of aerobic and resistance exercise in breast cancer patients receiving adjuvant chemotherapy: a multicenter randomized controlled trial. J Clin Oncol. 2007;25:4396–404.CrossRefPubMed
13.
Ballard-Barbash R, Friedenreich CM, Courneya KS, Siddiqi SM, McTiernan A, Alfano CM. Physical activity, biomarkers, and disease outcomes in cancer survivors: a systematic review. J Natl Cancer Inst. 2012;104:815–40.CrossRefPubMedPubMedCentral
14.
Friedenreich CM, Woolcott CG, McTiernan A, Ballard-Barbash R, Brant RF, Stanczyk FZ, et al. Alberta physical activity and breast cancer prevention trial: sex hormone changes in a year-long exercise intervention among postmenopausal women. J Clin Oncol. 2010;28:1458–66.CrossRefPubMedPubMedCentral
15.
Ligibel JA, Campbell N, Partridge A, Chen WY, Salinardi T, Chen H, et al. Impact of a mixed strength and endurance exercise intervention on insulin levels in breast cancer survivors. J Clin Oncol. 2008;26:907–12.CrossRefPubMed
16.
Massoner P, Ladurner-Rennau M, Eder IE, Klocker H. Insulin-like growth factors and insulin control a multifunctional signalling network of significant importance in cancer. Br J Cancer. 2010;103:1479–84.CrossRefPubMedPubMedCentral
17.
de Salles BF, Simao R, Fleck SJ, Dias I, Kraemer-Aguiar LG, Bouskela E. Effects of resistance training on cytokines. Int J Sports Med. 2010;31:441–50.CrossRefPubMed
18.
Kruijsen-Jaarsma M, Revesz D, Bierings MB, Buffart LM, Takken T. Effects of exercise on immune function in patients with cancer: a systematic review. Exerc Immunol Rev. 2013;19:120–43.PubMed
19.
Quinten C, Coens C, Mauer M, Comte S, Sprangers MA, Cleeland C, et al. Baseline quality of life as a prognostic indicator of survival: a meta-analysis of individual patient data from EORTC clinical trials. Lancet Oncol. 2009;10:865–71.CrossRefPubMed
20.
Bonnetain F, Dahan L, Maillard E, Ychou M, Mitry E, Hammel P, et al. Time until definitive quality of life score deterioration as a means of longitudinal analysis for treatment trials in patients with metastatic pancreatic adenocarcinoma. Eur J Cancer. 2010;46:2753–62.CrossRefPubMed
21.
Wolin KY, Schwartz AL, Matthews CE, Courneya KS, Schmitz KH. Implementing the exercise guidelines for cancer survivors. J Support Oncol. 2012;10(5):171–7.CrossRefPubMedPubMedCentral
22.
Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvão DA, Pinto BM, et al. American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 2010;42:1409–26.CrossRefPubMed
23.
Rock CL, Doyle C, Demark-Wahnefried W, Meyerhardt J, Courneya KS, Schwartz AL, et al. Nutrition and physical activity guidelines for cancer survivors. CA Cancer J Clin. 2012;62:242–74.CrossRef
24.
Buffart LM, Galvao DA, Brug J, Chinapaw MJ, Newton RU. Evidence-based physical activity guidelines for cancer survivors: current guidelines, knowledge gaps and future research directions. Cancer Treat Rev. 2014;40:327–40.CrossRefPubMed
25.
Hutzler Y, Sherrill C. Defining adapted physical activity: international perspectives. Adapt Phys Activ Q. 2007;24:1–20.CrossRefPubMed
26.
Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011;61:69–90.CrossRefPubMed
27.
28.
Reyes-Gibby CC, Chan W, Abbruzzese JL, Xiong HQ, Ho L, Evans DB, et al. Patterns of self-reported symptoms in pancreatic cancer patients receiving chemoradiation. J Pain Symptom Manage. 2007;34:244–52.CrossRefPubMedPubMedCentral
29.
Muller-Nordhorn J, Roll S, Bohmig M, Nocon M, Reich A, Braun C, et al. Health-related quality of life in patients with pancreatic cancer. Digestion. 2006;74:118–25.CrossRefPubMed
30.
31.
Maisonneuve P, Lowenfels AB. Epidemiology of pancreatic cancer: an update. Dig Dis. 2010;28:645–56.CrossRefPubMed
32.
Bao B, Wang Z, Li Y, Kong D, Ali S, Banerjee S, et al. The complexities of obesity and diabetes with the development and progression of pancreatic cancer. Biochim Biophys Acta. 2011;1815:135–46.PubMed
33.
O’Rorke MA, Cantwell MM, Cardwell CR, Mulholland HG, Murray LJ. Can physical activity modulate pancreatic cancer risk? A systematic review and meta-analysis. Int J Cancer. 2010;126:2957–68.PubMed
34.
Dong X, Javle M, Hess KR, Shroff R, Abbruzzese JL, Li D. Insulin-like growth factor axis gene polymorphisms and clinical outcomes in pancreatic cancer. Gastroenterology. 2010;139:464–73. 473 e461-463.CrossRefPubMedPubMedCentral
35.
Bergmann U, Funatomi H, Yokoyama M, Beger HG, Korc M. Insulin-like growth factor I overexpression in human pancreatic cancer: evidence for autocrine and paracrine roles. Cancer Res. 1995;55:2007–11.PubMed
36.
Agustsson T, D’Souza MA, Nowak G, Isaksson B. Mechanisms for skeletal muscle insulin resistance in patients with pancreatic ductal adenocarcinoma. Nutrition. 2011;27:796–801.CrossRefPubMed
37.
Greer JB, Whitcomb DC. Inflammation and pancreatic cancer: an evidence-based review. Curr Opin Pharmacol. 2009;9:411–8.CrossRefPubMed
38.
Fearon K, Arends J, Baracos V. Understanding the mechanisms and treatment options in cancer cachexia. Nat Rev Clin Oncol. 2013;10:90–9.CrossRefPubMed
39.
Husebo AM, Karlsen B, Allan H, Søreide JA, Bru E. Factors perceived to influence exercise adherence in women with breast cancer participating in an exercise programme during adjuvant chemotherapy: a focus group study. J Clin Nurs. 2015;24:500–10.CrossRefPubMed
40.
Regan TW, Lambert SD, Girgis A, Kelly B, Kayser K, Turner J. Do couple-based interventions make a difference for couples affected by cancer? A systematic review. BMC Cancer. 2012;12:279.CrossRefPubMedPubMedCentral
41.
Moses AW, Slater C, Preston T, Barber MD, Fearon KC. Reduced total energy expenditure and physical activity in cachectic patients with pancreatic cancer can be modulated by an energy and protein dense oral supplement enriched with n-3 fatty acids. Br J Cancer. 2004;90:996–1002.CrossRefPubMedPubMedCentral
42.
Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, et al. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013;369:1691–703.CrossRef
43.
Conroy T, Desseigne F, Ychou M, Bouché O, Guimbaud R, Bécouarn Y, et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011;364:1817–25.CrossRefPubMed
44.
Hammel P, Huguet F, van Laethem JL, Goldstein D, Glimelius B, Artru P, et al. Comparison of chemoradiotherapy (CRT) and chemotherapy (CT) in patients with a locally advanced pancreatic cancer (LAPC) controlled after 4 months of gemcitabine with or without erlotinib: final results of the international phase III LAP 07 study. J Clin Oncol. 2013;31:abstr LBA4003.
45.
Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45:228–47.CrossRefPubMed
46.
Aboodarda SJ, George J, Mokhtar AH, Thompson M. Muscle strength and damage following two modes of variable resistance training. J Sports Sci Med. 2011;10:635–42.PubMedPubMedCentral
47.
Colado JC, Triplett NT. Effects of a short-term resistance program using elastic bands versus weight machines for sedentary middle-aged women. J Strength Cond Res. 2008;22:1441–8.CrossRefPubMed
48.
Brzycki M. Strength testing — predicting a one-rep max from reps-to-fatigue. JOPERD. 1997;64:88–90.
49.
Page PA, Labbe A, Topp RV. Clinical force production of TheraBand® elastic bands. JOSPT. 2000;30:A47.
50.
Smets EM, Garssen B, Bonke B, De Haes JC. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res. 1995;39:315–25.CrossRefPubMed
51.
Gentile S, Delaroziere JC, Favre F, Sambuc R, San Marco JL. Validation of the French ‘multidimensional fatigue inventory’ (MFI 20). Eur J Cancer Care (Engl). 2003;12:58–64.CrossRef
52.
Purcell A, Fleming J, Bennett S, Burmeister B, Haines T. Determining the minimal clinically important difference criteria for the Multidimensional Fatigue Inventory in a radiotherapy population. Support Care Cancer. 2010;18:307–15.CrossRefPubMed
53.
Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85:365–76.CrossRefPubMed
54.
Osoba D, Rodrigues G, Myles J, Zee B, Pater J. Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol. 1998;16:139–44.PubMed
55.
Anota A, Hamidou Z, Paget-Bailly S, Chibaudel B, Bascoul-Mollevi C, Auquier P, et al. Time to health-related quality of life score deterioration as a modality of longitudinal analysis for health-related quality of life studies in oncology: do we need RECIST for quality of life to achieve standardization? Qual Life Res. 2015;24:5–18.CrossRefPubMed
56.
Bonnetain F, Bonsing B, Conroy T, Dousseau A, Glimelius B, Haustermans K, et al. Guidelines for time-to-event end-point definitions in trials for pancreatic cancer. Results of the DATECAN initiative (Definition for the Assessment of Time-to-event End-points in CANcer trials). Eur J Cancer. 2014;50:2983–93.CrossRefPubMed
57.
Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singapore. 1994;23:129–38.PubMed
58.
Poundja J, Fikretoglu D, Guay S, Brunet A. Validation of the French version of the brief pain inventory in Canadian veterans suffering from traumatic stress. J Pain Symptom Manage. 2007;33:720–6.CrossRefPubMed
59.
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67:361–70.CrossRefPubMed
60.
Razavi D, Delvaux N, Farvacques C, Robaye E. Validation of the French version of the Hospital Anxiety and Depression Scale (HADS) in a population of hospitalized cancer patients. Revue de Psychologie Appliquée. 1989;39:295–307.
Metadata
Title
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
Authors
Cindy Neuzillet
Mathieu Vergnault
Franck Bonnetain
Pascal Hammel
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0983-8

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