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Prostate CancerETADAPTNCT04832113

Impact of Patient's Therapeutic Education in APA and Dietetic on Radiotherapy Reproducibility Sessions for Prostate Cancer

A study testing Adapted Physical Activity and Dietetic and conventional management in people with Prostate Cancer, run by Centre Leon Berard at 5 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The primary objective of this study is to evaluate the impact of Patient's Therapeutic Education (PTE) in Adapted Physical Activity (APA) ans dietetic on the reduction of interventions number on rectal volume (laxative or probe). Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Adapted Physical Activity and Dietetic and conventional management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
5 sitesFrance
Study dates
21 Jun 2021to Apr 2025
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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • I1: Age >= 18 years old.
  • I2: Patient with prostatic adenocarcinoma with indication for first-line or post-operative radiotherapy (adjuvant or biologic recurrence).
  • I3: Patient able to practice a physical activity (certificate of aptitude for adapted physical activity).
  • I4: Life expectancy greater than 6 months.
  • I5: Absence of chronic inflammatory intestinal disease or intestinal surgery.
  • I6: Signed informed consent.
  • I7: Patient covered by a medical insurance.
  • I8. At least 20 sessions of radiotherapy planned

Who cannot join

  • E1: Patient does not understand and cannot read French.
  • E2: Patient followed for a psychiatric pathology or presenting cognitive disorders.
  • E3: Inability to comply with study follow-up goegraphical, social or psychological reasons.
  • E4: Patient requiring tutorship or curatorship or patient deprived of liberty.
  • E5: Participation to another clinical trial which may interfere with principal Endpoint assessment.

Trial locations and contacts

5 sites in 1 country.

Séverine METZGER contact

+33478782786

severine.metzger@lyon.unicancer.fr

Pascale Roux contact

+33478787200

pascale.roux@lyon.unicancer.fr

5 sites in 1 country

France5 sites, 5 recruiting

  • Groupe Hospitalier Mutualiste de Grenoble Institut Daniel HOLLARD

    Grenoble, 38028

    Olivia DIAZ, MD, o-diaz@ghm-grenoble.fr

    Recruiting

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

    Samy HORN, MD, samy.horn@chu-lyon.fr

    Not yet recruiting

  • Centre Eugène Marquis

    Rennes, 35042

    Manon BATY, MD, m.baty@rennes.unicancer.fr

    Recruiting

  • Chu de saint etienne

    Saint-Etienne, Rhône-Alpes Auvergne, 42000

    Thomas REYNAUD, MD

    Thomas.Reynaud@chu-st-etienne.fr

    Not yet recruiting

  • Institut de Cancérologie de l'Ouest René Gauducheau

    Saint-Herblain, 44805

    Stéphane SUPIOT, MD, stephane.supiot@ico.unicancer.fr

    Not yet recruiting

Other trials in France

About this study

Official title: ETADAPT- Evaluation of the Impact of Patient's Therapeutic Education (PTE) in Adapted Physical Activity (APA) and Dietetic on the Reproducibility of Radiotherapy Sessions for Prostate Cancers.

The primary objective of this study is to evaluate the impact of Patient's Therapeutic Education (PTE) in Adapted Physical Activity (APA) ans dietetic on the reduction of interventions number on rectal volume (laxative or probe).

The secondary objectives are to evaluate the contribution of Patient's Therapeutic Education (PTE) between the 2 arms on repositionnind during the radiotherapy session, the gastrointestinal toxicity, the need to use laxative or transit regulating treatment or techniques, the quality of life, the undernutrition and food intake, the evolution in eating/hydratation and physical habits.

For the experimetal arm, the satisfaction and the compliance with PTE program will be evaluated, as well as the need of additionnal use of dietary and APA consultations.

Read the detailed description

Prostate cancer is the 3rd cause of cancer mortality in patient aged over 50 years. Radiotherapy treatment plans require specific conditions:

  • Reproductibility of patient's positioning (requiring management of bladder and rectal fillings at each session).
  • An image-guided treatment consisting in acquiring an image before each session. This pre-treatment Imaging allows the optimal adjustment of the target volume and organs at risk (bladder and rectum).

To allow reproductibility of target volume positioning at each radiotherapy session, it's recommended to have an empty rectum at the time of the radiotherapy preparation scan, and to check repletion before each session.

It's recommended that the patient has a comfortably full bladder to limit the volume of irradiated bladder mucosa. The radiotherapy teams don't have any recommendations concerning the rectum and manage this problem session by session, according to the repositioning Imaging of the current day.

According to a pilot study carried out in 2017 in the radiotherapy department of the Léon Bérard center, an intervention for a dilated rectum (probe or laxative) was necessary for an average of 25% of session per patient.

These rectal problems can be partly explained by the age (60-80 years) and sedentary lifestyle of patients with prostate cancer. Physical activities, adapted hydratation and changes in eating habits are an integral part of the constipation and flatulence prevention.

Conditions
Prostate Cancer
Being tested
Adapted Physical Activity and Dietetic, conventional management
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Adapted Physical Activity and DieteticOther

    Also called Follow-up of Adapted Physical Activity and Dietetic Hydratation

    session in addtion conventional management dietetic, hydratation and physical activity

  • conventional managementOther

    Also called conventional management dietary and hydratation

    Dietary and hydratation advices according to the recommendations

Study groups in NCT04832113
Study groupRoleWhat they receive
Patient Therapeutics Education (PTE)ExperimentalEducational diagnosis prior radiotherapy and participation to Patient Therapeutics Education (PTE) in Adapted Physical Activity (APA) and dietetic sessions. In addition to conventional support (dietary and hydration advice).
Receives: Other: Adapted Physical Activity and Dietetic
Conventional supportOtherDietary and hydration advices
Receives: Other: conventional management

What is being measured

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

  1. Evaluate the impact of Patient's Therapeutic Education in APA on the reduction of interventions number on rectum

    Number of uninstallation during the radiotherapy session

    Measured: An average of 4 months

Secondary outcomes (18)

  1. Evaluate the contribution of Patient's Therapeutic Education on patient's repositionning efficiency

    Rate of patients never uninstalled compared to patients uninstalled during prostate's radiotherapy

    Measured: An average of 4 months

  2. Evaluate the contribution of Patient's Therapeutic Education on the gastrointestinal toxicity

    Acute gastrointestinal toxicity ≥ grade 2 (NCI- CTCAE V5)

    Measured: An average of 4 months

  3. Evaluate the contribution of Patient's Therapeutic Education on the use of laxative or transit regulating treatment or techniques

    Prescribed laxatives or transit regulation treatments or techniques

    Measured: An average of 4 months

  4. Evaluate the contribution of Patient's Therapeutic Education on patients' quality of life

    Using European Organisation for Research and Treatment of Cancer - Core Quality of life questionnaire (QLQC30) (Evaluation of patient's quality of life during the last 7 days - From 4 [worse reply] to 1 [better reply])

    Measured: An average of 4 months

  5. Evaluate the contribution of Patient's Therapeutic Education on the undernutrition

    Collection of patients' weight (kg)

    Measured: An average of 4 months

  6. Evaluate the contribution of Patient's Therapeutic Education on the food intake

    Collection of patients' weight (kg)

    Measured: An average of 4 months

  7. Evaluate the contribution of Patient's Therapeutic Education on the undernutrition

    Using Socio Economic Factor Index scale (SEFI) (Scale from 10 [I ate my entire meal] to 0 [I did not eat anything])

    Measured: An average of 4 months

  8. Evaluate the contribution of Patient's Therapeutic Education on the food intake

    Using Socio Economic Factor Index scale (SEFI) (Scale from 10 [I ate my entire meal] to 0 [I did not eat anything])

    Measured: An average of 4 months

  9. Evaluate the contribution of Patient's Therapeutic Education on the undernutrition

    Using the "Eating and hydration habits questionnaire"

    Measured: An average of 4 months

  10. Evaluate the contribution of Patient's Therapeutic Education on the food intake

    Using the "Eating and hydration habits questionnaire"

    Measured: An average of 4 months

  11. Evaluate the contribution of Patient's Therapeutic Education on the evolution in eating habits

    Using the "Eating and hydration habits questionnaire"

    Measured: An average of 4 months

  12. Evaluate the contribution of Patient's Therapeutic Education on the evolution in hydratation habits

    Using the "Eating and hydration habits questionnaire"

    Measured: An average of 4 months

  13. Evaluate the contribution of Patient's Therapeutic Education on the evolution in APA habits

    Using International Physical Activity Questionnaire (IPAQ) (Description of the physical activity during the last 7 days)

    Measured: An average of 4 months

  14. Evaluate patient's satisfaction with Patient's Therapeutic Education program (experimental arm)

    Using satisfaction questionnaire (scale from 1 [worse evaluation] to 4 [better evaluation])

    Measured: An average of 4 months

  15. Evaluate the compliance to APA session recommendations

    Daily collection of steps numbers

    Measured: An average of 4 months

  16. Evaluate the compliance to APA session recommendations

    Evaluation during phone calls every 15 days

    Measured: An average of 4 months

  17. Evaluate the number of patients requiring additional dietetic session

    Evaluation during phone calls every 15 days

    Measured: An average of 4 months

  18. Evaluate the number of patients requiring additional APA session

    Evaluation during phone calls every 15 days

    Measured: An average of 4 months

Timeline

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

  1. First posted5 Apr 2021
  2. Study start21 Jun 2021
  3. Primary completionOct 2024 (estimated)
  4. Study completionApr 2025 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
216 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04832113
Sponsor's protocol ID
ET20-0284 ETADAPT
Acronym
ETADAPT
Status last verified
Aug 2023
First submitted
11 Mar 2021
Last updated
31 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Adapted Physical Activity and Dietetic and conventional management in people with Prostate Cancer, run by Centre Leon Berard at 5 sites 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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

Results are not available in the source record.

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

Contact Séverine METZGER (+33478782786, severine.metzger@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the impact of Patient's Therapeutic Education in APA on the reduction of interventions number on rectum (time frame: An average of 4 months). 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 NCT04832113.

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 31 Aug 2023.

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