Trial Outcomes & Findings for Evaluation of an Exercise Intervention for Vincristine Induced Peripheral Neuropathy in Pediatric Cancer Patients (NCT NCT03430674)

Results Overview

Subjects will complete greater than 50% of exercise sessions during 8 week intervention. Subject report satisfaction with the intervention via questionnaires.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

8 weeks

Results posted on

2023-03-27

Participant Flow

Participant milestones

Participant milestones
Measure	Exercise Intervention Clinic and at home exercise sessions. Exercise: Exercise, questionnaires and blood draws.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exercise Intervention n=10 Participants Interventions administered for clinic and at home exercise sessions: Exercise-15 minute sessions daily that include resistance and aerobic training. All training sessions will be provided via an online video they can access at any time. In addition, each session will address 3 core, 3 lower body and 3 upper body exercises that will last 50 seconds each for a total of 10 minutes.
Age, Categorical <=18 years	7 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=10 Participants
Age, Categorical >=65 years	0 Participants n=10 Participants
Age, Continuous	16 years n=10 Participants
Sex: Female, Male Female	4 Participants n=10 Participants
Sex: Female, Male Male	6 Participants n=10 Participants
Region of Enrollment United States	10 participants n=10 Participants
Baseline Neuropathy	8 units on a scale n=10 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Looking at % sessions completed during 8 week program per subject.

Subjects will complete greater than 50% of exercise sessions during 8 week intervention. Subject report satisfaction with the intervention via questionnaires.

Outcome measures

Outcome measures
Measure	Feasibility n=10 Participants 50 % compliance
Number of Participants With Greater Than 50% Compliance to Exercise Regimen	0 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Any parent or caregiver with a child involved in the study.

Parents will also be asked to complete a satisfaction survey regarding the exercise program, DVDs, and therapist support. The satisfaction survey consists of 13 items. Scores were on a Likert scale 1-5, 1 - strongly disagree and 5 - strongly agree. The total range is 13-65 with 65 being the greatest satisfaction possible and 13 being the worst satisfaction possible.

Outcome measures

Outcome measures
Measure	Feasibility n=8 Participants 50 % compliance
Acceptability - Parent Satisfaction Survey	4.096 score on a scale Standard Deviation 0.301

SECONDARY outcome

Timeframe: 8 weeks

Population: Patients over the age of 5. Scores were averaged from Likert scale.

Patients will provide feedback on the exercise program, DVDs, and therapist support. The satisfaction survey consists of 13 items. The scale is 1-5 with 1 - strongly disagree and 5 - strongly agree. The total range is 13-65 with 65 being the greatest satisfaction possible and 13 being the worst satisfaction possible.

Outcome measures

Outcome measures
Measure	Feasibility n=7 Participants 50 % compliance
Acceptability - Patient Satisfaction Survey	3.945 score on a scale Standard Deviation 0.365

SECONDARY outcome

Timeframe: 8 weeks

Total Neuropathy Score Pediatric Version; Range for each subscale is 0 to 4 with 0 being normal and 4 being the worst neuropathy. The total range is 0-36. 0 being no neuropathy. 36 being highest neuropathy possible.

Outcome measures

Outcome measures
Measure	Feasibility n=10 Participants 50 % compliance
Pediatric Neuropathy	6 score on a scale Interval 5.0 to 7.0

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Population: The difference between pre and post intervention score is the analysis.

Quality of Life: Pediatric Quality of Life Inventory; Each is 0 to 4 with 0 being never and 4 being almost always. The total scale score, the mean is computed as the sum of all the items over the number of items answered on all the scales. The difference between pre and post QOL scores. Total scale score consists of 4 dimensions, physical, emotional, social, and school functioning. Scores are transformed on a scale from 0-100. The greater the score the better the quality of life.

Outcome measures

Outcome measures
Measure	Feasibility n=6 Participants 50 % compliance
Quality of Life - Changes in Quality of Life From Pre Intervention to Post Intervention a Total of 8 Weeks.	8.17 score on a scale Standard Deviation 14.81

SECONDARY outcome

Timeframe: Baseline (T1=week 6) and T2=week 14

Changes in PDGF-BB (Platelet Derived Growth Factor) levels in plasma from pre to post intervention.

Outcome measures

Outcome measures
Measure	Feasibility n=10 Participants 50 % compliance
PDGF-BB Levels (Platelet Derived Growth Factor)	66.03 percentage of baseline Standard Deviation 186.21

SECONDARY outcome

Timeframe: Baseline (T1=week 6) and T2=week 14

Change in NGF (Nerve Growth Factor) in plasma from pre to post intervention.

Outcome measures

Outcome measures
Measure	Feasibility n=10 Participants 50 % compliance
NGF (Nerve Growth Factor)	37.98 percentage of baseline NGF Standard Deviation 144.42

SECONDARY outcome

Timeframe: 8 weeks

Population: Changes in neuropathy scores as correlated with quality of life scores.

Analyzing the correlation of changes in quality of life scores with neuropathy scores using Pearson's correlation coefficient.

Outcome measures

Outcome measures
Measure	Feasibility n=4 Participants 50 % compliance
Quality of Life as a Result in Changes in Neuropathy Scores.	0.80 Pearson's correlation coefficient

Adverse Events

Exercise Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jamie Renbarger, MD

Indiana University

Phone: 317-944-8784

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place