Autohypnosis and Cancerology


Therapeutical hypnosis is proven to be an effective medical support to chemotherapy: it was shown that it can reduce the pain, anxiety, fatigue felt by the patient.

Yet, hypnosis requires the presence of an hypnotherapist, which is why auto-hypnosis could be an efficient alternative to handle the side effects of chemotherapy.

In this study, colorectal cancer and breast cancer patients are either taught auto-hypnosis or are taken in standard care for their chemotherapy.

The life quality score (QLQC30) assessed during and after chemotherapies will determine if auto-hypnosis is a good medical support in chemotherapies' adverse effects management.

The proven benefices of auto-hypnosis in the handling of the side effects of chemotherapies could improve the quality of life of cancer affected patients.

Full Title of Study: “Prospective, Randomized Study Aiming to Assess the Benefit of Autohypnosis Learning in the Care of Patients Treated by Adjuvant Chemotherapy for Colorectal or Breast Cancer.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2020


  • Other: Autohypnosis learning
    • Patients are taught how to do auto-hypnosis by an hypnotherapist before all along their chemotherapy.

Arms, Groups and Cohorts

  • Experimental: Autohypnosis learning
    • In this arm, patients are taught autohypnosis during sessions in groups of 3 to 6 with a qualified hypnotherapist. Sessions are set every two weeks, for a total of 6 sessions. Individual sessions are possible for patients who missed a session.
  • No Intervention: Standard of care
    • In this arm, patients are not taught autohypnosis and are treated according to standard of care.

Clinical Trial Outcome Measures

Primary Measures

  • >20% increase of the EORTC QLQC30 score (annexe 1) at the third week after the last chemotherapy session in the auto-hypnosis arm compared to the standard care arm.
    • Time Frame: 3 weeks after the last chemotherapy session
    • At the third week after the last chemotherapy session, patients answer the quality of life survey (EORTC QLQC30). Arms’ mean score are compared, a minimal difference of 21% is needed for statistical significance.

Secondary Measures

  • Evaluation of auto-hypnosis effects on the life quality and global health of patients at short, mid, and long term.
    • Time Frame: 3rd week and 6 month after the last treatment and either one in two chemotherapy sessions, or each chemotherapy session if XELOX treatment
    • Patients answer the quality of life survey (EORTC QLQC30) one in two chemotherapy session, or each session for XELOX therapy.
  • Evaluation of auto-hypnosis effects on different components of quality of life.
    • Time Frame: 3rd week and 6 month after the last treatment and either one in two chemotherapy sessions, or each chemotherapy session if XELOX treatment
    • Quantitative evaluation of QLQ-C30 subdomains
  • Evaluation of auto-hypnosis effects on different components of quality of life specific to breast cancer
    • Time Frame: 3rd week and 6 month after the last treatment and either one in two chemotherapy sessions, or each chemotherapy session if XELOX treatment
    • Quantitative evaluation of QLQ-BR23 scores
  • Evaluation of auto-hypnosis effects on different components of quality of life specific to colorectal cancer.
    • Time Frame: 3rd week and 6 month after the last treatment and either one in two chemotherapy sessions, or each chemotherapy session if XELOX treatment
    • Quantitative evaluation of QLQ-CR29 scores
  • Evaluation of auto-hypnosis effects on drug consumption.
    • Time Frame: 3rd week and 6 month after the last treatment and either one in two chemotherapy sessions, or each chemotherapy session if XELOX treatment
    • Patients answer a survey about their consumption of different type of drugs : pain-killers, antiemetics, anxiolytics, sleeping drugs.
  • Evaluation of auto-hypnosis effects on fatigue.
    • Time Frame: 3rd week and 6 month after the last treatment and either one in two chemotherapy sessions, or each chemotherapy session if XELOX treatment
    • Evaluation of fatigue score MFI-20
  • Evaluation of auto-hypnosis impact on anxiety and/or depression.
    • Time Frame: 3rd week and 6 month after the last treatment and either one in two chemotherapy sessions, or each chemotherapy session if XELOX treatment
    • Evaluation of HADS score
  • Evaluation of auto-hypnosis impact on the global medical handling of their cancer.
    • Time Frame: 3rd week and 6 month after the last treatment
    • Numerical scale of satisfaction survey (from 0 to 10) 0 will mean “very unsatisfied” and 10 will mean “very satisfied”.
  • Evaluation of patient’s satisfaction about auto-hypnosis therapies.
    • Time Frame: 3rd week and 6 month after the last treatment
    • Satisfaction survey about their satisfaction about auto-hypnosis therapies

Participating in This Clinical Trial

Inclusion Criteria

  • Age superior or equal to 18 years old
  • Colorectal or breast cancer history, treated by surgery and that should undergo an adjuvant chemotherapy
  • In the case of breast cancer, adjuvant chemotherapy must involve anthracyclines
  • ECOG performance score < 3
  • Patient must be affiliated or beneficiary of social security or any similar regime

Exclusion Criteria

  • Patients already included in another interventional clinical research protocol
  • Patients unable to proceed to hypnosis treatment due to their speech limitations (poor comprehension and expression of french, deafness, mental illness)
  • Patients protected by French law from clinical inclusion ( pregnant, in labour, breastfeeding, legally protected, under judiciary or administrative liberty deprivation…)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Groupe Hospitalier Mutualiste de Grenoble
  • Collaborator
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Valerie Armand, +33 (0)4 76 28 50 81,


Faivre J, Grosclaude P, Launoy G, Arveux P, Raverdy N, Menegoz F, Pienkowski P, Schaffer P, Daures JP, De Vathaire F. [Digestive cancers in France. Geographic distribution and estimation of national incidence]. Gastroenterol Clin Biol. 1997;21(3):174-80. French.

Edge SB, Compton CC. The American Joint Committee on Cancer: the 7th edition of the AJCC cancer staging manual and the future of TNM. Ann Surg Oncol. 2010 Jun;17(6):1471-4. doi: 10.1245/s10434-010-0985-4.

Gunderson LL, Jessup JM, Sargent DJ, Greene FL, Stewart AK. Revised TN categorization for colon cancer based on national survival outcomes data. J Clin Oncol. 2010 Jan 10;28(2):264-71. doi: 10.1200/JCO.2009.24.0952. Epub 2009 Nov 30.

Sargent DJ, Marsoni S, Monges G, Thibodeau SN, Labianca R, Hamilton SR, French AJ, Kabat B, Foster NR, Torri V, Ribic C, Grothey A, Moore M, Zaniboni A, Seitz JF, Sinicrope F, Gallinger S. Defective mismatch repair as a predictive marker for lack of efficacy of fluorouracil-based adjuvant therapy in colon cancer. J Clin Oncol. 2010 Jul 10;28(20):3219-26. doi: 10.1200/JCO.2009.27.1825. Epub 2010 May 24. Erratum in: J Clin Oncol. 2010 Oct 20;28(30):4664.

Moertel CG, Fleming TR, Macdonald JS, Haller DG, Laurie JA, Goodman PJ, Ungerleider JS, Emerson WA, Tormey DC, Glick JH, et al. Levamisole and fluorouracil for adjuvant therapy of resected colon carcinoma. N Engl J Med. 1990 Feb 8;322(6):352-8.

Zaniboni A, Labianca R, Marsoni S, Torri V, Mosconi P, Grilli R, Apolone G, Cifani S, Tinazzi A. GIVIO-SITAC 01: A randomized trial of adjuvant 5-fluorouracil and folinic acid administered to patients with colon carcinoma–long term results and evaluation of the indicators of health-related quality of life. Gruppo Italiano Valutazione Interventi in Oncologia. Studio Italiano Terapia Adiuvante Colon. Cancer. 1998 Jun 1;82(11):2135-44.

Efficacy of adjuvant fluorouracil and folinic acid in colon cancer. International Multicentre Pooled Analysis of Colon Cancer Trials (IMPACT) investigators. Lancet. 1995 Apr 15;345(8955):939-44.

Haller DG, Tabernero J, Maroun J, de Braud F, Price T, Van Cutsem E, Hill M, Gilberg F, Rittweger K, Schmoll HJ. Capecitabine plus oxaliplatin compared with fluorouracil and folinic acid as adjuvant therapy for stage III colon cancer. J Clin Oncol. 2011 Apr 10;29(11):1465-71. doi: 10.1200/JCO.2010.33.6297. Epub 2011 Mar 7.

Schmoll HJ, Tabernero J, Maroun J, de Braud F, Price T, Van Cutsem E, Hill M, Hoersch S, Rittweger K, Haller DG. Capecitabine Plus Oxaliplatin Compared With Fluorouracil/Folinic Acid As Adjuvant Therapy for Stage III Colon Cancer: Final Results of the NO16968 Randomized Controlled Phase III Trial. J Clin Oncol. 2015 Nov 10;33(32):3733-40. doi: 10.1200/JCO.2015.60.9107. Epub 2015 Aug 31.

André T, Boni C, Navarro M, Tabernero J, Hickish T, Topham C, Bonetti A, Clingan P, Bridgewater J, Rivera F, de Gramont A. Improved overall survival with oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment in stage II or III colon cancer in the MOSAIC trial. J Clin Oncol. 2009 Jul 1;27(19):3109-16. doi: 10.1200/JCO.2008.20.6771. Epub 2009 May 18.

Schmoll HJ, Twelves C, Sun W, O'Connell MJ, Cartwright T, McKenna E, Saif M, Lee S, Yothers G, Haller D. Effect of adjuvant capecitabine or fluorouracil, with or without oxaliplatin, on survival outcomes in stage III colon cancer and the effect of oxaliplatin on post-relapse survival: a pooled analysis of individual patient data from four randomised controlled trials. Lancet Oncol. 2014 Dec;15(13):1481-1492. doi: 10.1016/S1470-2045(14)70486-3. Epub 2014 Nov 12.

Association of Breast Surgery at Baso 2009. Surgical guidelines for the management of breast cancer. Eur J Surg Oncol. 2009;35 Suppl 1:1-22. doi: 10.1016/j.ejso.2009.01.008. Epub 2009 Mar 18.

Hammond ME. ASCO-CAP guidelines for breast predictive factor testing: an update. Appl Immunohistochem Mol Morphol. 2011 Dec;19(6):499-500. doi: 10.1097/PAI.0b013e31822a8eac. Review.

Harbeck N, Sotlar K, Wuerstlein R, Doisneau-Sixou S. Molecular and protein markers for clinical decision making in breast cancer: today and tomorrow. Cancer Treat Rev. 2014 Apr;40(3):434-44. doi: 10.1016/j.ctrv.2013.09.014. Epub 2013 Sep 29. Review.

Wazir U, Mokbel K. Emerging gene-based prognostic tools in early breast cancer: First steps to personalised medicine. World J Clin Oncol. 2014 Dec 10;5(5):795-9. doi: 10.5306/wjco.v5.i5.795.

Early Breast Cancer Trialists' Collaborative Group (EBCTCG), Peto R, Davies C, Godwin J, Gray R, Pan HC, Clarke M, Cutter D, Darby S, McGale P, Taylor C, Wang YC, Bergh J, Di Leo A, Albain K, Swain S, Piccart M, Pritchard K. Comparisons between different polychemotherapy regimens for early breast cancer: meta-analyses of long-term outcome among 100,000 women in 123 randomised trials. Lancet. 2012 Feb 4;379(9814):432-44. doi: 10.1016/S0140-6736(11)61625-5. Epub 2011 Dec 5.

Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 May 14-20;365(9472):1687-717.

Senkus E, Kyriakides S, Ohno S, Penault-Llorca F, Poortmans P, Rutgers E, Zackrisson S, Cardoso F; ESMO Guidelines Committee. Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015 Sep;26 Suppl 5:v8-30. doi: 10.1093/annonc/mdv298.

Gianni L, Dafni U, Gelber RD, Azambuja E, Muehlbauer S, Goldhirsch A, Untch M, Smith I, Baselga J, Jackisch C, Cameron D, Mano M, Pedrini JL, Veronesi A, Mendiola C, Pluzanska A, Semiglazov V, Vrdoljak E, Eckart MJ, Shen Z, Skiadopoulos G, Procter M, Pritchard KI, Piccart-Gebhart MJ, Bell R; Herceptin Adjuvant (HERA) Trial Study Team. Treatment with trastuzumab for 1 year after adjuvant chemotherapy in patients with HER2-positive early breast cancer: a 4-year follow-up of a randomised controlled trial. Lancet Oncol. 2011 Mar;12(3):236-44. doi: 10.1016/S1470-2045(11)70033-X. Epub 2011 Feb 25.

Slamon D, Eiermann W, Robert N, Pienkowski T, Martin M, Press M, Mackey J, Glaspy J, Chan A, Pawlicki M, Pinter T, Valero V, Liu MC, Sauter G, von Minckwitz G, Visco F, Bee V, Buyse M, Bendahmane B, Tabah-Fisch I, Lindsay MA, Riva A, Crown J; Breast Cancer International Research Group. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011 Oct 6;365(14):1273-83. doi: 10.1056/NEJMoa0910383.

Goldhirsch A, Gelber RD, Piccart-Gebhart MJ, de Azambuja E, Procter M, Suter TM, Jackisch C, Cameron D, Weber HA, Heinzmann D, Dal Lago L, McFadden E, Dowsett M, Untch M, Gianni L, Bell R, Köhne CH, Vindevoghel A, Andersson M, Brunt AM, Otero-Reyes D, Song S, Smith I, Leyland-Jones B, Baselga J; Herceptin Adjuvant (HERA) Trial Study Team. 2 years versus 1 year of adjuvant trastuzumab for HER2-positive breast cancer (HERA): an open-label, randomised controlled trial. Lancet. 2013 Sep 21;382(9897):1021-8. doi: 10.1016/S0140-6736(13)61094-6. Epub 2013 Jul 18.

Pivot X, Romieu G, Debled M, Pierga JY, Kerbrat P, Bachelot T, Lortholary A, Espié M, Fumoleau P, Serin D, Jacquin JP, Jouannaud C, Rios M, Abadie-Lacourtoisie S, Tubiana-Mathieu N, Cany L, Catala S, Khayat D, Pauporté I, Kramar A; PHARE trial investigators. 6 months versus 12 months of adjuvant trastuzumab for patients with HER2-positive early breast cancer (PHARE): a randomised phase 3 trial. Lancet Oncol. 2013 Jul;14(8):741-8. doi: 10.1016/S1470-2045(13)70225-0. Epub 2013 Jun 11.

Rodary C, Leplège A, Hill C. [Evaluation of the quality of life in clinical research in cancerology]. Bull Cancer. 1998 Feb;85(2):140-8. Review. French.

Osoba D. What has been learned from measuring health-related quality of life in clinical oncology. Eur J Cancer. 1999 Oct;35(11):1565-70. Review.

de Haes J, Curran D, Young T, Bottomley A, Flechtner H, Aaronson N, Blazeby J, Bjordal K, Brandberg Y, Greimel E, Maher J, Sprangers M, Cull A. Quality of life evaluation in oncological clinical trials – the EORTC model. The EORTC Quality of Life Study Group. Eur J Cancer. 2000 May;36(7):821-5.

Moinpour CM. Do quality of life assessments make a difference in the evaluation of cancer treatments? Control Clin Trials. 1997 Aug;18(4):311-7.

Trask PC, Hsu MA, McQuellon R. Other paradigms: health-related quality of life as a measure in cancer treatment: its importance and relevance. Cancer J. 2009 Sep-Oct;15(5):435-40. doi: 10.1097/PPO.0b013e3181b9c5b9. Review.

Johnson JR, Temple R. Food and Drug Administration requirements for approval of new anticancer drugs. Cancer Treat Rep. 1985 Oct;69(10):1155-9.

Gotay CC, Kawamoto CT, Bottomley A, Efficace F. The prognostic significance of patient-reported outcomes in cancer clinical trials. J Clin Oncol. 2008 Mar 10;26(8):1355-63. doi: 10.1200/JCO.2007.13.3439. Epub 2008 Jan 28. Review.

Osoba D. Translating the science of patient-reported outcomes assessment into clinical practice. J Natl Cancer Inst Monogr. 2007;(37):5-11. Review.

Montazeri A. Quality of life data as prognostic indicators of survival in cancer patients: an overview of the literature from 1982 to 2008. Health Qual Life Outcomes. 2009 Dec 23;7:102. doi: 10.1186/1477-7525-7-102. Review.

Quinten C, Coens C, Mauer M, Comte S, Sprangers MA, Cleeland C, Osoba D, Bjordal K, Bottomley A; EORTC Clinical Groups. Baseline quality of life as a prognostic indicator of survival: a meta-analysis of individual patient data from EORTC clinical trials. Lancet Oncol. 2009 Sep;10(9):865-71. doi: 10.1016/S1470-2045(09)70200-1. Epub 2009 Aug 18.

Braun DP, Gupta D, Grutsch JF, Staren ED. Can changes in health related quality of life scores predict survival in stages III and IV colorectal cancer? Health Qual Life Outcomes. 2011 Aug 3;9:62. doi: 10.1186/1477-7525-9-62.

Earlam S, Glover C, Fordy C, Burke D, Allen-Mersh TG. Relation between tumor size, quality of life, and survival in patients with colorectal liver metastases. J Clin Oncol. 1996 Jan;14(1):171-5.

Lis CG, Gupta D, Granick J, Grutsch JF. Can patient satisfaction with quality of life predict survival in advanced colorectal cancer? Support Care Cancer. 2006 Nov;14(11):1104-10. Epub 2006 Jul 4.

McKernan M, McMillan DC, Anderson JR, Angerson WJ, Stuart RC. The relationship between quality of life (EORTC QLQ-C30) and survival in patients with gastro-oesophageal cancer. Br J Cancer. 2008 Mar 11;98(5):888-93. doi: 10.1038/sj.bjc.6604248. Epub 2008 Feb 12.

Efficace F, Bottomley A, Coens C, Van Steen K, Conroy T, Schöffski P, Schmoll H, Van Cutsem E, Köhne CH. Does a patient's self-reported health-related quality of life predict survival beyond key biomedical data in advanced colorectal cancer? Eur J Cancer. 2006 Jan;42(1):42-9. Epub 2005 Nov 18. Erratum in: Eur J Cancer. 2007 Feb;43(3):633.

Grande GE, Farquhar MC, Barclay SI, Todd CJ. Quality of life measures (EORTC QLQ-C30 and SF-36) as predictors of survival in palliative colorectal and lung cancer patients. Palliat Support Care. 2009 Sep;7(3):289-97. doi: 10.1017/S1478951509990216. Erratum in: Palliat Support Care. 2009 Dec;7(4):533.

Maisey NR, Norman A, Watson M, Allen MJ, Hill ME, Cunningham D. Baseline quality of life predicts survival in patients with advanced colorectal cancer. Eur J Cancer. 2002 Jul;38(10):1351-7.

Montgomery GH, Schnur JB, Kravits K. Hypnosis for cancer care: over 200 years young. CA Cancer J Clin. 2013 Jan;63(1):31-44. doi: 10.3322/caac.21165. Epub 2012 Nov 20. Review.

Lang EV, Berbaum KS, Faintuch S, Hatsiopoulou O, Halsey N, Li X, Berbaum ML, Laser E, Baum J. Adjunctive self-hypnotic relaxation for outpatient medical procedures: a prospective randomized trial with women undergoing large core breast biopsy. Pain. 2006 Dec 15;126(1-3):155-64. Epub 2006 Sep 7.

Montgomery GH, Weltz CR, Seltz M, Bovbjerg DH. Brief presurgery hypnosis reduces distress and pain in excisional breast biopsy patients. Int J Clin Exp Hypn. 2002 Jan;50(1):17-32.

Schnur JB, Bovbjerg DH, David D, Tatrow K, Goldfarb AB, Silverstein JH, Weltz CR, Montgomery GH. Hypnosis decreases presurgical distress in excisional breast biopsy patients. Anesth Analg. 2008 Feb;106(2):440-4, table of contents. doi: 10.1213/ane.0b013e31815edb13.

Liossi C, White P, Hatira P. A randomized clinical trial of a brief hypnosis intervention to control venepuncture-related pain of paediatric cancer patients. Pain. 2009 Apr;142(3):255-63. doi: 10.1016/j.pain.2009.01.017. Epub 2009 Feb 23.

Montgomery GH, Bovbjerg DH, Schnur JB, David D, Goldfarb A, Weltz CR, Schechter C, Graff-Zivin J, Tatrow K, Price DD, Silverstein JH. A randomized clinical trial of a brief hypnosis intervention to control side effects in breast surgery patients. J Natl Cancer Inst. 2007 Sep 5;99(17):1304-12. Epub 2007 Aug 28.

Kamen C, Tejani MA, Chandwani K, Janelsins M, Peoples AR, Roscoe JA, Morrow GR. Anticipatory nausea and vomiting due to chemotherapy. Eur J Pharmacol. 2014 Jan 5;722:172-9. doi: 10.1016/j.ejphar.2013.09.071. Epub 2013 Oct 21. Review.

Redd WH, Montgomery GH, DuHamel KN. Behavioral intervention for cancer treatment side effects. J Natl Cancer Inst. 2001 Jun 6;93(11):810-23. Review.

Montgomery GH, David D, Kangas M, Green S, Sucala M, Bovbjerg DH, Hallquist MN, Schnur JB. Randomized controlled trial of a cognitive-behavioral therapy plus hypnosis intervention to control fatigue in patients undergoing radiotherapy for breast cancer. J Clin Oncol. 2014 Feb 20;32(6):557-63. doi: 10.1200/JCO.2013.49.3437. Epub 2014 Jan 13.

Montgomery GH, Kangas M, David D, Hallquist MN, Green S, Bovbjerg DH, Schnur JB. Fatigue during breast cancer radiotherapy: an initial randomized study of cognitive-behavioral therapy plus hypnosis. Health Psychol. 2009 May;28(3):317-22. doi: 10.1037/a0013582.

Grégoire C, Bragard I, Jerusalem G, Etienne AM, Coucke P, Dupuis G, Lanctôt D, Faymonville ME. Group interventions to reduce emotional distress and fatigue in breast cancer patients: a 9-month follow-up pragmatic trial. Br J Cancer. 2017 Nov 7;117(10):1442-1449. doi: 10.1038/bjc.2017.326. Epub 2017 Sep 19.

Bedard G, Zeng L, Zhang L, Lauzon N, Holden L, Tsao M, Danjoux C, Barnes E, Sahgal A, Poon M, Chow E. Minimal important differences in the EORTC QLQ-C30 in patients with advanced cancer. Asia Pac J Clin Oncol. 2014 Jun;10(2):109-17. doi: 10.1111/ajco.12070. Epub 2013 Apr 1.

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 Jan;16(1):139-44.

Zelen M. Randomized consent designs for clinical trials: an update. Stat Med. 1990 Jun;9(6):645-56.

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