Impact of a Sensory Rehabilitation Program on Olfactory-gustatory Alterations in Patients Treated With Chemotherapy for Haematological Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Assessment of the olfactometry
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and ≤ 75 years old
- •Patient with olfactory or gustatory disorders
- •Patient who has completed chemotherapy for haematological cancer
排除标准
- •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
研究组 & 干预措施
Interventional
Patients in the interventional arm will follow a multifactorial sensory rehabilitation program focused on smell and taste that integrates several non-drug interventions, which are part of the current recommendations: program of workshops at the technical center, hydration of the mucous membranes with daily (3 times a day) liposomal sprays (LipoSaliva® and LipoNasal) between V0 and V1, presentation of visual dishes.
The workshops will take place at the frequency of one session of 2 hours per week and will last for 3 weeks. Each session will accommodate a minimum of 2 participants. The program will include 3 workshops on olfactory rehabilitation and taste rehabilitation.
Exercises (taking up the themes discussed) will be carried out at home between 2 workshops.
干预措施: Multifactorial sensory rehabilitation workshops (Other)
Interventional
Patients in the interventional arm will follow a multifactorial sensory rehabilitation program focused on smell and taste that integrates several non-drug interventions, which are part of the current recommendations: program of workshops at the technical center, hydration of the mucous membranes with daily (3 times a day) liposomal sprays (LipoSaliva® and LipoNasal) between V0 and V1, presentation of visual dishes.
The workshops will take place at the frequency of one session of 2 hours per week and will last for 3 weeks. Each session will accommodate a minimum of 2 participants. The program will include 3 workshops on olfactory rehabilitation and taste rehabilitation.
Exercises (taking up the themes discussed) will be carried out at home between 2 workshops.
干预措施: Tests and Questionnaire (Other)
Control
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.
Patients in the control group will be able to benefit from the rehabilitation workshops if they wish at the end of the study.
干预措施: Usual care (Other)
Control
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.
Patients in the control group will be able to benefit from the rehabilitation workshops if they wish at the end of the study.
干预措施: Tests and Questionnaire (Other)
结局指标
主要结局
Assessment of the olfactometry
时间窗: 3 months
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)
次要结局
- Variation of Taste and Smell Survey score(up to 6 months)
- Assessment of the physical activity(up to 6 months)
- Variation of the patient weight(up to 6 months)
- Assessment of the gustometry(up to 6 months)
- Assessment of the Quality of life(Up to 6 months)
- Assessment of the Psychological distress(u pto 6 months)