Appetite and Related Factors in Patients With ALS

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Detection of Appetite and Analysis of Related Factors in Patients With Amyotrophic Lateral Sclerosis (ALS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04953624
• Other study ID #: M2020399
• Status: Recruiting
• Start date: August 1, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: June 2021
• Source: Peking University Third Hospital
• Contact: Dongsheng Fan
• Phone: +86 13701023871
• Email: dsfan[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Chinese cnaq scale was used to evaluate the appetite changes of Chinese ALS patients; Objective to investigate the related factors of appetite changes in ALS patients; Objective to investigate the effect of anorexia on the progression and survival of ALS patients.

Description:

1. With the consent of the original author, the scale was translated and back translated, and the Chinese version of the scale was determined after communication and confirmation with the original author.

2. Cnaq was used to measure the appetite of the patients, and hads was used to measure the anxiety and depression of the patients;

3. Analyze the proportion of loss of appetite in ALS group, compare the differences of clinical characteristics such as ALSFRS-R score, weight, BMI value, cognitive status such as ECAs score between patients with loss of appetite and patients without loss of appetite in ALS group, and conduct correlation analysis.

4. The patients were followed up every three months until they were unable to eat or end-point events (invasive ventilator or death), and the correlation between cnaq and disease progression and survival was analyzed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• ALS patients diagnosed as probable, or definite according to the revised El Escorial criteria

Exclusion Criteria:

• there are other chronic consumption diseases such as severe digestive system diseases, thyroid diseases, diabetes and so on.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Diagnostic Test:
• Appetite rating scale CNAQ
Chinese version of Appetite rating scale CNAQ

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ALSFRS-R score		3 months
Primary	ALSFRS-R score		6 months
Primary	ALSFRS-R score		12 months
Primary	Food intake	Inability to eat	3 months
Primary	Food intake	Inability to eat	6 months
Primary	Food intake	Inability to eat	12 months
Primary	invasive ventilator or death	end point events	3 months
Primary	invasive ventilator or death	end point events	6 months
Primary	invasive ventilator or death	end point events	12 months