Cancer Related Cognitive Impairment

Patients Treated for Cancer Clinical Trial

— APACO  

Official title:

Physical Activity, Cancer and Cognitive Function Disorders : Effects of an Adapted Physical Activity Program on Impaired Cognitive Function in the Management of Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03949322
• Other study ID #: ICO-N-2018-21
• Status: Recruiting
• Phase: N/A
• Start date: February 28, 2019
• Est. completion date: September 2019

Study information

• Verified date: May 2019
• Source: Institut Cancerologie de l'Ouest
• Contact: BOIFFARD Florence, MD
• Phone: +33240679900
• Email: florence.boiffard[@]ico.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Various recent scientific data testify to the cognitive deficiencies of cancer patients, called Cancer-Related Cognitive Impairments (CRCI) (Noal, Daireaux & Joly, 2010). At the same time, regular physical activity (aerobic, muscle building, and yoga) has been shown to decrease CRCIs, although commonly used cognitive measures are self-reported (Zimmer et al., 2016). The investigators will develop an interventional study using objective measures of cognition to confirm the cause-and-effect relationship, and specify the orientation of the cognitive effects of the adapted physical activities. The main and original objective will be to determine if the cognitive functions most affected by CRCI (episodic memory, inhibition, treatment speed) can be optimized in patients undergoing treatment.

Description:

1. Inclusion procedure and saving selection failures Participation in this study will be offered to patients during their care in day hospital (= inclusion visit).

Any patient giving express consent to participation and meeting the criteria for inclusion and non-inclusion will then be included in the study.

Each patient will then be identified by his or her initials as a patient number in the study, directly on the basis of collecting the data from the study.

2. Study progress for patients Data collection takes place over two different periods. Each period lasts 12 weeks. The Adapted Physical Activity (APA) program is 8 weeks old.

The first period will run from mid-January to early April (first cohort) to collect data from the first patients in the experimental group.

The second period will be from mid-February to the end of April. During this one, it will be necessary to collect the data of the last patients of the experimental group (second cohort) The first two weeks of each period (weeks 1 and 2, weeks 4 and 5) are dedicated to recruiting patients.

During the pre-test session, carried out week 3 for the first cohort and weeks 6 for the second, the patients will carry out different tests and questionnaires: General Information Questionnaires, Education, MoCA (Montreal Cognitive Assessment), GPAQ (Global Physical Activity Questionnaire), Stroop test, test of MEM3 (Echelle Clinique de Mémoire), letter comparison test, HADS (Hospital and Anxiety Depression Scale), and the MFI (Multidimensional Fatigue Inventory). Patients should also wear an actimeter for one week from the day of recruitment.

Patients then take part in a program of Adapted Physical Activity lasting 8 weeks, with 2 sessions per week. The sessions of this program are similar to the APA sessions already offered by sports therapy practitioners. This is an aerobic exercise session, with Nordic walking, and a combined session of muscle building and breathing-based exercises.

In the post-test session, which was conducted week 12 for the first cohort and week 15 for the second, some questionnaires and tests are again administered: GPAQ, Stroop test, MEM3 test, letter comparison test, HADS and the MFI. Patients should also wear an actimeter the week before the day of the post-test.

The forecast schedule may be slightly modified depending on unforeseen circumstances and constraints that may occur.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: September 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female> or = 18 years old

2. Any patient being treated for a cancerous condition and managed by adjuvant chemotherapy.

3. Any type of cancer

4. Beneficiary of a social protection scheme

5. Having as mother tongue the French language

6. Patient information and obtaining express consent

Exclusion Criteria:

1. Protected subjects known as vulnerable (major under legal protection, adults unable to express their consent, subject admitted to a health and social institution).

2. Minor subjects

3. Pregnant women, likely to be pregnant or breastfeeding

4. Subjects with sensory disabilities affecting vision or hearing

5. Neurological or psychiatric antecedents

6. Persons deprived of liberty or guardianship (including trusteeship).

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Patients Treated for Cancer

Intervention

Behavioral:
• Adapted Physical Activity Program
The sessions in this program are similar to the adapted physical activity sessions already offered by sports therapy practitioners. This is an aerobic exercise session, with Nordic walking, and a combined session of muscle building and breathing exercises.

Locations

Country	Name	City	State
France	Institut de Cancérologie de l'Ouest	Saint-Herblain

Sponsors (2)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest	University of Poitiers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of an APA program on cognitive functions (inhibition)	For inhibition, effect of APA program on cognitive functions is evaluated with Stroop task.	8 weeks
Primary	Effect of an APA program on cognitive functions (speed function of information processing)	For speed function of information processing, effect of APA program on cognitive functions is evaluated with XO letters comparison test. During the XO letters comparison test, the participants will have to check the maximum number of identical or different boxes according to the combination of the two letters presented (XO, OX, XX or OO) in 30 seconds.	8 weeks
Primary	Effect of an APA program on cognitive functions (Episodic Memory Function)	For Episodic Memory Function, effect of APA program on cognitive functions is evaluated with MEM III test.	8 weeks
Secondary	To determine if the APA program modifies PA (Physical Activity) patterns in daily life	Evaluated with Global Physical Activity Questionnaire	8 weeks
Secondary	To determine if the APA program modifies PA (Physical Activity) patterns in daily life	Evaluated with Actimeter	8 weeks
Secondary	Determine which PA pattern is the best predictor of cognitive performance improvement following the APA program, , by controlling the effect of cognitive risk factors.	Level of overall cognitive abilities: Montreal Cognitive Assessment (MOCA)	8 weeks
Secondary	Determine which PA pattern is the best predictor of cognitive performance improvement following the APA program, , by controlling the effect of cognitive risk factors.	Level of education: questionnaire measuring the number of years of study	8 weeks
Secondary	Determine which PA pattern is the best predictor of cognitive performance improvement following the APA program, , by controlling the effect of cognitive risk factors.	Level of Anxiety and Depression: Hospital and Anxiety Depression Scale (HADS).	8 weeks
Secondary	Determine which PA pattern is the best predictor of cognitive performance improvement following the APA program, , by controlling the effect of cognitive risk factors.	Fatigue level: Multidimensional Fatigue Inventor (MFI)	8 weeks