Evaluation of the Impact of Chemotherapy on Body Odor in Adolescents and Young Adults in Oncology

Solid Tumor, Adult Clinical Trial

— ODORAJA  

Official title:

ODORAJA:Evaluation of the Impact of Chemotherapy on Body Odor in Adolescents and Young Adults in Oncology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04899505
• Other study ID #: IC 2021-02
• Status: Recruiting
• Start date: October 21, 2021
• Est. completion date: October 21, 2025

Study information

• Verified date: January 2023
• Source: Institut Curie
• Contact: Aurélie Thuleau
• Phone: +33 1 44324228
• Email: drci.promotion[@]curie.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The appearance of unpleasant body odors in adolescent Young adult (aya) wille be evaluated undergoing chemotherapy

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 21, 2025
• Est. primary completion date: October 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 25 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Chemotherapy Effect
• Neoplasms
• Solid Tumor, Adult
• Solid Tumor, Childhood

Intervention

Other:
• Evaluation on appearance of unpleasant body odors
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.

Locations

Country	Name	City	State
France	Institut Curie	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	8 months
Secondary	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)	8 months
Secondary	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)	8 months
Secondary	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)	8 months