Solid Tumor, AdultODORAJANCT04899505
Evaluation of the Impact of Chemotherapy on Body Odor in Adolescents and Young Adults in Oncology
An observational study of Solid Tumor, Adult and Solid Tumor, Childhood, run by Institut Curie at 1 site in France.
Trial summary
The appearance of unpleasant body odors in adolescent Young adult (aya) wille be evaluated undergoing chemotherapy Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Solid Tumor, Adult, Solid Tumor, Childhood, Chemotherapy Effect
- What is being tested?
- Evaluation on appearance of unpleasant body odors
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 21 Oct 2021to 12 May 2025
- Phase
- Observational
- 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 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patients aged between 15 and 25 years with solid tumors
Who may be able to join
- Patients aged between 15 and 25 years;
- New patients treated at the Curie Institute and hospitalized in the AJA oncology department;
- Patient undergoing chemotherapy administered intravenously;
- Solid tumors.
Who cannot join
- Patient undergoing oral chemotherapy;
- Persons deprived of their liberty or under guardianship (including guardianship);
- Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ODORAJA:Evaluation of the Impact of Chemotherapy on Body Odor in Adolescents and Young Adults in Oncology
The appearance of unpleasant body odors in adolescent Young adult (aya) wille be evaluated undergoing chemotherapy
- Being tested
- Evaluation on appearance of unpleasant body odors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation on appearance of unpleasant body odorsOther
Percentage of patients reporting discomfort with unpleasant body odor that occurred during their treatment. This percentage will be calculated from the response to item Q1 of the patient questionnaire during the fourth course of chemotherapy in the AJA oncology department.
| Study group | Role | What they receive |
|---|---|---|
| Evaluation on appearance of unpleasant body odors | Incidence of the development of unpleasant body odors in AYA oncology patients Receives: Other: Evaluation on appearance of unpleasant body odors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of the development of unpleasant body odors in AYA oncology patients
Percentage of patients reporting discomfort with unpleasant body odor that occurred during their treatment. This percentage will be calculated from the response to item Q1 of the patient questionnaire during the fourth course of chemotherapy in the AJA oncology department
Measured: 8 months
Secondary outcomes (3)
Qualification of the smell and the discomfort felt
Answers to the investigation intended for patients for the appearance of the smell with different proposals like sweating, urine, breath etc. (Q2), its qualifier with different proposals like desagreable, infective, nauseating, etc…(Q3) and the discomfort observed for themselves or for those around them (Q8)
Measured: 8 months
Quantification of the discomfort and the impact on quality of life
Answers to the investigation intended for patients to assess the intensity of the smell with a scale (0= no smell and 10 = strong smell) (Q4), its daily impact with a scale (0=no impact and 10= high impact) (Q7) and solutions that can reduce smell with different proposals like perfume, cream, essential oil (Q9)
Measured: 8 months
Identify possible causes of the appearance of these new body odors
Answers to the investigation for patients to assess the link between smell and drug treatment with different proposals like treatment, hospital's food or hospital cleaning product (Q5 and Q6)
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start21 Oct 2021
- Primary completion12 May 2025
- Study completion12 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899505
- Sponsor's protocol ID
- IC 2021-02
- Acronym
- ODORAJA
- Status last verified
- Jan 2023
- First submitted
- 19 May 2021
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ODORAJA:Evaluation of the Impact of Chemotherapy on Body Odor in Adolescents and Young Adults in Oncology
- ClinicalTrials.gov ID
- NCT04899505
- Acronym / sponsor ID
- ODORAJA / IC 2021-02
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 12 May 2025 (actual)
- Study completion
- 12 May 2025 (actual)
- First posted
- 24 May 2021 (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 appearance of unpleasant body odors in adolescent Young adult (aya) wille be evaluated undergoing chemotherapy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation on appearance of unpleasant body odors | – | Other: Evaluation on appearance of unpleasant body odorsIncidence of the development of unpleasant body odors in AYA oncology patients |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients aged between 15 and 25 years with solid tumors
Key inclusion criteria (4 listed)
- Patients aged between 15 and 25 years;
- New patients treated at the Curie Institute and hospitalized in the AJA oncology department;
- Patient undergoing chemotherapy administered intravenously;
- Solid tumors.
Key exclusion criteria (3 listed)
- Patient undergoing oral chemotherapy;
- Persons deprived of their liberty or under guardianship (including guardianship);
- Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons.
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 |
|---|---|---|
| Evaluation on appearance of unpleasant body odorsPercentage of patients reporting discomfort with unpleasant body odor that occurred during their treatment. This percentage will be calculated from the response to item Q1 of the patient questionnaire during the fourth course of chemotherapy in the AJA oncology department. | Other | Evaluation on appearance of unpleasant body odors |
Primary outcome
Incidence of the development of unpleasant body odors in AYA oncology patients
Time frame: 8 months
Percentage of patients reporting discomfort with unpleasant body odor that occurred during their treatment. This percentage will be calculated from the response to item Q1 of the patient questionnaire during the fourth course of chemotherapy in the AJA oncology department
3 secondary outcomes
Qualification of the smell and the discomfort felt
Time frame: 8 months
Quantification of the discomfort and the impact on quality of life
Time frame: 8 months
Identify possible causes of the appearance of these new body odors
Time frame: 8 months
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 16 May 2025.
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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?
An observational study of Solid Tumor, Adult and Solid Tumor, Childhood, run by Institut Curie 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 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 16 May 2025. 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?
Incidence of the development of unpleasant body odors in AYA oncology patients (time frame: 8 months). 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 16 May 2025.