Physical Exercise and Dairy Probiotics in Childhood Cancer Survivors

NCT ID: NCT05939791

Last Updated: 2024-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2023-12-31

Brief Summary

The goal of this clinical trial is to to compare the structure of the intestinal microbiome between children shortly after treatment for acute lymphoblastic leukemia (1-3 years after cancer treatment) and healthy controls. And then to provoke a positive shift of bacterial diversity by physical activity and probiotics in cured pediatric oncology patients with persistent gut microbiome disruptions.

The main question[s] it aims to answer are:

• Are differences in bacterial richness between healthy controls and pediatric oncology patients ≥12 months after cancer treatment apparent?
• Has the combination of physical exercise and probiotics had a positive influence on the structure of the gut microbiome in childhood cancer survivors in remission? Two times per week of physical activity and daily dairy consumption with probiotics will be required of participants for eight weeks.

Conditions

Acute Lymphoblastic Leukemia, Pediatric

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Exercise training

Children previously diagnosed and treated for acute lymphoblastic leukemia in remission between 1 and 3 years with physical exercise intervention

Group Type: EXPERIMENTAL

Lacticaseibacillus paracasei subsp. Paracasei CNCMI-1518

Intervention Type: OTHER

The commercial probiotic dairy product has been provided to PALL along with physical training once a day for 8 weeks. Each serving contained 20 billion CFUs of Lacticaseibacillus paracasei subsp. Paracasei CNCMI-1518 (Lactobacillus casei CNCMI-1518). Each patient's legal representative was advised to follow a normal diet when preparing and providing food for children.

Physical exercise

Intervention Type: OTHER

The individual online (MS Teams) training program for PALL in the length of 8 weeks included 25-45 minutes of moderate-to-vigorous physical exercise, twice a week, under the supervision. The structure of the exercise program was developed to improve endurance and gradually rebuild muscular strength. The exercise program's structure was created to increase endurance and gradually rebuild muscular strength. Large muscle groups were the focus of training sessions, which also placed a strong emphasis on proper technique. A strength exercise squat was given consideration as a movement required to meet necessities. (e.g., sitting or standing). Each exercise consisted of between 10 and 15 repetitions in each series and 2 to 3 series overall.

Passive

Children previously diagnosed and treated for acute lymphoblastic leukemia in remission between 1 and 3 years without physical exercise intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lacticaseibacillus paracasei subsp. Paracasei CNCMI-1518

The commercial probiotic dairy product has been provided to PALL along with physical training once a day for 8 weeks. Each serving contained 20 billion CFUs of Lacticaseibacillus paracasei subsp. Paracasei CNCMI-1518 (Lactobacillus casei CNCMI-1518). Each patient's legal representative was advised to follow a normal diet when preparing and providing food for children.

Intervention Type: OTHER

Physical exercise

The individual online (MS Teams) training program for PALL in the length of 8 weeks included 25-45 minutes of moderate-to-vigorous physical exercise, twice a week, under the supervision. The structure of the exercise program was developed to improve endurance and gradually rebuild muscular strength. The exercise program's structure was created to increase endurance and gradually rebuild muscular strength. Large muscle groups were the focus of training sessions, which also placed a strong emphasis on proper technique. A strength exercise squat was given consideration as a movement required to meet necessities. (e.g., sitting or standing). Each exercise consisted of between 10 and 15 repetitions in each series and 2 to 3 series overall.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• children previously diagnosed and treated for acute lymphoblastic leukemia in remission between 1 and 3 years

Exclusion Criteria

• acute respiratory infection during intervention
• more than 20% skipped exercise training sessions

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Comenius University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Pediatric Hematology National Institute of Children's Diseases Bratislava

Bratislava, , Slovakia

Countries

Slovakia

Other Identifiers

22-0047

Identifier Type: -

Identifier Source: org_study_id