Chemotherapy EffectPASITHEANCT05649852
Anxiolytic Effects of Socio-aesthetics in Cancer Patients Undergoing Chemotherapy
A study testing Socio-aesthetic care and Supportive care in people with Chemotherapy Effect, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The purpose of the study is to assess the average of the "State Anxiety" score of the State Trait Inventory Anxiety at the end of the third cycle of chemotherapy compared to the pre-treatment score (inclusion) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy Effect
- What is being tested?
- Socio-aesthetic care and Supportive care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteFrance
- Study dates
- 23 Mar 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patient with cancer treated with adjuvant chemotherapy with an interval of 14 or 21 days for the first 3 cycles;
- Chemotherapy naïve patient;
- Patient speaking and understanding French and able to complete the questionnaires;
- Patient having been informed and having signed an informed consent form to participate in the study.
Who cannot join
- Patient who has already benefited from socio-aesthetic care;
- Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision);
- Patient unable to understand the information related to the study (linguistic, psychological, cognitive reasons, etc.);
- Pregnant or likely to be pregnant (of childbearing age, without effective contraception) or breastfeeding;
- Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
- Patient not benefiting from a social security scheme.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Privé Drôme Ardèche
Valence, 26000
Louis DOUBLET, MD, 4 75 75 87 93 ext. +33, l.doublet@ramsaygds.fr
About this study
Official title: Anxiolytic Effects of Socio-aesthetics in Cancer Patients Undergoing Chemotherapy (PASITHEA)
The purpose of the study is to assess the average of the "State Anxiety" score of the State Trait Inventory Anxiety at the end of the third cycle of chemotherapy compared to the pre-treatment score (inclusion)
Read the detailed description
As part of this study, patients will be seen 6 times for the purposes of the study: on inclusion, during the first four courses of chemotherapy and at the end of chemotherapy.
The study is offered to the patient during the consultation with the oncologist before the start of chemotherapy. It may possibly be proposed at the latest when he enters hospitalization for chemotherapy.
Two cohorts of patients will be included:
- Patients treated with chemotherapy every 21 days for lung, breast, digestive, colorectal or gynecological cancer;
- Patients treated with chemotherapy every 14 days for digestive or other cancer.
- Conditions
- Chemotherapy Effect
- Being tested
- Socio-aesthetic care, Supportive care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socio-aesthetic careOther
Group A (Socio-aesthetic care): 3 sessions carried out by a socio-esthetician, during the first administration of chemotherapy.
Supportive careOther
Group B (control) will not benefit of socio-aesthetic care during chemotherapy but will benefit all existing support care in the center and accessible to patients: psychology consultation, sophrology, art therapy, physiotherapy, hypnosis. The patient will receive support care (maximum 2) during the intercure.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy | Other | Adjuvant chemotherapy treatment Receives: Other: Socio-aesthetic care; Other: Supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of mean of the "State Anxiety" score of the State Trait Inventory Anxiety
Change of mean of the "State Anxiety" score of the State Trait Inventory Anxiety at the end of the third cycle of chemotherapy compared to the pre-treatment score (inclusion)
Measured: Between the inclusion and the end of the third cycle of chemotherapy (maximum cycle of 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start23 Mar 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy EffectStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Euraxi Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649852
- Sponsor's protocol ID
- 2022-A01822-41
- Acronym
- PASITHEA
- Status last verified
- Jan 2026
- First submitted
- 15 Nov 2022
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiolytic Effects of Socio-aesthetics in Cancer Patients Undergoing Chemotherapy (PASITHEA)
- ClinicalTrials.gov ID
- NCT05649852
- Acronym / sponsor ID
- PASITHEA / 2022-A01822-41
- Conditions
- Chemotherapy Effect
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Euraxi Pharma
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 14 Dec 2022 (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.
The purpose of the study is to assess the average of the "State Anxiety" score of the State Trait Inventory Anxiety at the end of the third cycle of chemotherapy compared to the pre-treatment score (inclusion)
Detailed description
As part of this study, patients will be seen 6 times for the purposes of the study: on inclusion, during the first four courses of chemotherapy and at the end of chemotherapy.
The study is offered to the patient during the consultation with the oncologist before the start of chemotherapy. It may possibly be proposed at the latest when he enters hospitalization for chemotherapy.
Two cohorts of patients will be included:
- Patients treated with chemotherapy every 21 days for lung, breast, digestive, colorectal or gynecological cancer;
- Patients treated with chemotherapy every 14 days for digestive or other cancer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | Other | Other: Socio-aesthetic care, Other: Supportive careAdjuvant chemotherapy treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with cancer treated with adjuvant chemotherapy with an interval of 14 or 21 days for the first 3 cycles;
- Chemotherapy naïve patient;
- Patient speaking and understanding French and able to complete the questionnaires;
- Patient having been informed and having signed an informed consent form to participate in the study.
Key exclusion criteria (6 listed)
- Patient who has already benefited from socio-aesthetic care;
- Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision);
- Patient unable to understand the information related to the study (linguistic, psychological, cognitive reasons, etc.);
- Pregnant or likely to be pregnant (of childbearing age, without effective contraception) or breastfeeding;
- Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
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 |
|---|---|---|
| Socio-aesthetic careGroup A (Socio-aesthetic care): 3 sessions carried out by a socio-esthetician, during the first administration of chemotherapy. | Other | Chemotherapy |
| Supportive careGroup B (control) will not benefit of socio-aesthetic care during chemotherapy but will benefit all existing support care in the center and accessible to patients: psychology consultation, sophrology, art therapy, physiotherapy, hypnosis. The patient will receive support care (maximum 2) during the intercure. | Other | Chemotherapy |
Primary outcome
Change of mean of the "State Anxiety" score of the State Trait Inventory Anxiety
Time frame: Between the inclusion and the end of the third cycle of chemotherapy (maximum cycle of 21 days)
Change of mean of the "State Anxiety" score of the State Trait Inventory Anxiety at the end of the third cycle of chemotherapy compared to the pre-treatment score (inclusion)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Socio-aesthetic care and Supportive care in people with Chemotherapy Effect, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 15 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Louis DOUBLET, MD (4 75 75 87 93 ext. +33, l.doublet@ramsaygds.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of mean of the "State Anxiety" score of the State Trait Inventory Anxiety (time frame: Between the inclusion and the end of the third cycle of chemotherapy (maximum cycle of 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2026.