Colorectal CancerNCT03429296

Autohypnosis and Cancerology

A study testing Autohypnosis learning in people with Colorectal Cancer and Breast Cancer, run by Groupe Hospitalier Mutualiste de Grenoble at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Colorectal Cancer, Breast Cancer
What is being tested?: Autohypnosis learning
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteFrance
Study dates: 23 May 2018to 1 Jul 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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...)

Trial locations and contacts

1 site in 1 country.

France1 site

Groupe hospitalier Mutualiste de Grenoble
Grenoble, 38028

Other trials in France

About this study

Official title: 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.

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.

Conditions: Colorectal Cancer, Breast Cancer
Being tested: Autohypnosis learning
Keywords: Cancer, Autohypnosis, Quality of life
Medical subject headings: Colorectal Neoplasms, Breast Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Autohypnosis learningOther
Patients are taught how to do auto-hypnosis by an hypnotherapist before all along their chemotherapy.

Study groups in NCT03429296
Study group	Role	What they receive
Autohypnosis learning	Experimental	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. Receives: Other: Autohypnosis learning
Standard of care	No intervention	In this arm, patients are not taught autohypnosis and are treated according to standard of care.

What is being measured

The primary outcome is the main question the study is designed to answer.

>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.
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.
Measured: 3 weeks after the last chemotherapy session

Secondary outcomes (9)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 May 20181 Jul 2022

First posted12 Feb 2018
Study start23 May 2018
Primary completion21 Jan 2022
Study completion1 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (53)Papers the sponsor has linked to this study.
Other trials for Colorectal CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: Zelen : patients will be randomized according to the Zelen randomization design (as described in "Zelen M. Randomized consent designs for clinical trials: An update. Stats in Med. 1990;9:645-656")
Masking: None (open label)
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03429296
Sponsor's protocol ID: 2017/12-SBO-GHMG
Status last verified: Mar 2023
First submitted: 5 Feb 2018
Last updated: 7 Mar 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 9161491
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.
PubMed 20180029
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.
PubMed 19949014
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.
PubMed 20498393
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. doi: 10.1056/NEJM199002083220602.
PubMed 2300087
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. doi: 10.1002/(sici)1097-0142(19980601)82:113.0.co;2-u.
PubMed 9610692
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.
PubMed 7715291
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.
PubMed 21383294
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.
PubMed 26324362
Andre 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.
PubMed 19451431
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.
PubMed 25456367
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. No abstract available.
PubMed 19299100
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.
PubMed 22089488
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.
PubMed 24138841
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.
PubMed 25493218

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT03429296
Acronym / sponsor ID: 2017/12-SBO-GHMG
Conditions: Colorectal Cancer, Breast Cancer
Keywords: Cancer, Autohypnosis, Quality of life
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Groupe Hospitalier Mutualiste de GrenobleUniversity, hospital or other
Collaborators: TIMC-IMAG, AG2R La Mondiale, GEFLUC, Espoir Isère Cancer
Study start: 23 May 2018 (actual)
Primary completion: 21 Jan 2022 (actual)
Study completion: 1 Jul 2022 (actual)
First posted: 12 Feb 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Zelen : patients will be randomized according to the Zelen randomization design (as described in "Zelen M. Randomized consent designs for clinical trials: An update. Stats in Med. 1990;9:645-656")

Arm	Type	Receives
Autohypnosis learning	Experimental	Other: Autohypnosis learningIn 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.
Standard of care	No intervention	–In this arm, patients are not taught autohypnosis and are treated according to standard of care.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (3 listed)

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...)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Autohypnosis learningPatients are taught how to do auto-hypnosis by an hypnotherapist before all along their chemotherapy.	Other	Autohypnosis learning

Primary outcome

>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.

9 secondary outcomes

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
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
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
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
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
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 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 auto-hypnosis impact on the global medical handling of their cancer.
Time frame: 3rd week and 6 month after the last treatment
Evaluation of patient's satisfaction about auto-hypnosis therapies.
Time frame: 3rd week and 6 month after the last treatment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
Background: PubMed 9161491Faivre 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.
Background: PubMed 20180029Edge 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.
Background: PubMed 19949014Gunderson 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.
Background: PubMed 20498393Sargent 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.
Background: PubMed 2300087Moertel 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. doi: 10.1056/NEJM199002083220602.
Background: PubMed 9610692Zaniboni 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. doi: 10.1002/(sici)1097-0142(19980601)82:113.0.co;2-u.
Background: PubMed 7715291Efficacy 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.
Background: PubMed 21383294Haller 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.
Background: PubMed 26324362Schmoll 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.
Background: PubMed 19451431Andre 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.
Background: PubMed 25456367Schmoll 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.
Background: PubMed 19299100Association 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. No abstract available.
13th citation (pdf)Link provided by the sponsor.
27th citationLink provided by the sponsor.
46th citation (pdf)Link provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Autohypnosis learning in people with Colorectal Cancer and Breast Cancer, run by Groupe Hospitalier Mutualiste de Grenoble at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

>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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03429296, which also lists 53 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.