Impact of a Sensory Rehabilitation Program on Olfactory-gustatory Alterations in Patients Treated With Chemotherapy for Haematological Cancer

Multiple Myeloma Clinical Trial

— RE-NEZ-SENS  

Official title:

Impact of a Sensory Rehabilitation Program on Olfactory-gustatory Alterations in Patients Treated With Chemotherapy for Haematological Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04716153
• Other study ID #: RECHMPL20_0187
• Status: Recruiting
• Phase: N/A
• Start date: June 25, 2021
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: University Hospital, Montpellier
• Contact: Franciane PAUL, Dr.
• Phone: 0033467338260
• Email: f-paul[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Proposition of a sensory rehabilitation program that could reduce the olfactory-gustatory alterations in patients who have been treated with chemotherapy for Haematological Cancer, and also improve their life quality, psychological well-being, and nutrition.

Description:

Disturbances in taste and smell affect a considerable proportion of patients treated with chemotherapy. In hematology, dysgeusia depends on the type pathology and the treatments themselves. It impacts the quality of life, leads to significant emotional and social consequences, affects the intake, weight and nutritional status of patients. Olfactory-taste disorders can be assessed using subjective and objective tests. There are no international clinical recommendations for the management of taste and olfactory disturbances associated with chemotherapy in hematological cancers. Also, this study proposes to evaluate a taste and olfaction rehabilitation program based on national standards and recent research. It will help fill gaps in the assessment and management of patients treated for Haematological cancer. Hypothesis is that this sensory rehabilitation program should make it possible to reduce the olfactory-gustatory changes in patients who have been treated with Chemotherapy for Haematological cancer and significantly improve their quality of life, their psychological well-being and their nutrition.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: December 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age between 18 and = 75 years old
• Patient with olfactory or gustatory disorders
• Patient who has completed chemotherapy for haematological cancer

Exclusion Criteria:

• Eating disorder known prior to anti-cancer treatment, bulimic, anorexic or binge eating disorder (DSM-V criteria)
• Refusal to sign the free and informed consent
• Hypersensitivity to one of the components of liposomal sprays (Liposaliva® or liponasal®)
• COVID + patient in the previous 3 months
• Performance status ECOG 3 or 4
• Patient included in another clinical trial modifying taste / olfaction
• Artificial nutrition post-chemotherapy
• Known food allergies
• Having a reading level in French that may interfere with a good understanding of the protocol and the questionnaires
• Presenting visual or hearing deficits uncorrected to normal and which may affect the proper completion of the questionnaires
• Patient under curatorship or tutorship.
• Patient deprived of liberty
• Pregnant or breastfeeding patient
• Not be affiliated with a French social security scheme or beneficiary of such a scheme

Related Conditions & MeSH terms

• Dysgeusia
• Lymphoma
• Multiple Myeloma
• Olfactivo-gustatory Disorder

Intervention

Other:
• Multifactorial sensory rehabilitation workshops
A multifactorial sensory rehabilitation Workshops : a multifactorial program in order to optimize the recovery of flavors, focused on smell and taste which integrates several non-drug interventions, which are part of the current recommendations: hydration of the mucous membranes with daily (3 times a day) liposomal sprays (nose and mouth), presentation of visual dishes.
• Usual care
The control group only receives the usual care provided for as part of routine care. It consists of a nutritional assessment at home by a dietician, with monitoring of intake and weight, in order to readjust nutritional support. A systematic search for oral mycosis is carried out in order to treat. The foods that the patient prefers, identified from a list of authorized foods, are preferred or even fortified.
• Tests and Questionnaire
fulfillment of Taste Strips Test, Sniffin'sticks test and QGO, FACT-G, HADS, l'EVA des ingesta and GPAQ questionnaires to assess the quality of life of patients

Locations

Country	Name	City	State
France	Hematology Department, University Hospital Center	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the olfactometry	Evolution of the Score of the "Sniffin'sticks" test from the initial score (V0), which itself includes an olfactory discrimination, olfactory threshold and olfactory identification score (with a cut-off of = 15 for anosmia, = for normonosmia and hypoanosmia for a score between 15 and 30)	3 months
Secondary	Assessment of the gustometry	Score in the "Taste Strips" test, Hypoageusia scores being for participants aged 18 to 40, <19 for women and <17 for men; for participants aged 41 to 60, score <15 for women and 9 for men; for participants over 60, score <10.2 for women and <9 for men	up to 6 months
Secondary	Variation of Taste and Smell Survey score	Variation of the taste and Smell Survey score	up to 6 months
Secondary	Assessment of the Quality of life	Quality of life scores, obtained on the FACT-G scale. This is a 27-point self-administered questionnaire that measures the quality of life of patients with cancer. The FACT-G measures physical, functional, social / family factors, and emotional well-being as well as physician / patient relationship satisfaction and concerns. All items are rated on a 5-point Likert scale based on the week prior to the assessment.	Up to 6 months
Secondary	Assessment of the Psychological distress	The psychological distress score objectified by the Hospital Anxiety Depression Scale (HADS). This self-questionnaire, validated in French, contains 14 items. It is simple, sensitive and specific. It has been validated in cancer patients, that it is rapid (completion time around 5 minutes), and allows the calculation of 2 sub-scores for anxiety and depression in addition to an overall level. Finally, this tool is sensitive to changes both during the course of medical illnesses and in response to psychopharmacological interventions.	u pto 6 months
Secondary	Assessment of the physical activity	assessed by the score at GPAQ scale (Bull, Maslin, & Armstrong, 2009)	up to 6 months
Secondary	Variation of the patient weight	assessed by BMI between the beginning and the end of the study	up to 6 months