Trial Outcomes & Findings for Physical Activity for Reduction of Recurrence Rate After Adjuvant Chemotherapy for Localised Colorectal Carcinoma (NCT NCT01210313)

NCT ID: NCT01210313

Last Updated: 2024-09-19

Results Overview

Evaluation of the feasibility measured in terms of training adherence during the first 12 weeks measured in actual participant-weeks in relation to the 360 planned participant-weeks during cycle 1 (week 1 to week 12)

• Recruitment status: COMPLETED
• Target enrollment: 30 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2024-09-19

Participant Flow

The first participant was enrolled October 7, 2010, the last participant was enrolled March 22, 2012. Enrollment took place in 7 Austrian clinical sites. In total, 30 participants were enrolled.

Participant milestones

Measure	Physical Exercise No treatment, only physical examinations accompanying physical exercise (defined exercise program)
Overall Study STARTED	30
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Measure	Physical Exercise No treatment, only physical examinations accompanying physical exercise (defined exercise program)
Overall Study Withdrawal by Subject	3
Overall Study Adverse Event	2
Overall Study Distant recurrence	4
Overall Study Non-compliance	7

Baseline Characteristics

Physical Activity for Reduction of Recurrence Rate After Adjuvant Chemotherapy for Localised Colorectal Carcinoma

Baseline characteristics by cohort

Measure	Total n=30 Participants All participants (patients with colorectal cancer after adjuvant chemotherapy) included in this single arm study.
Age, Continuous	55 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Cancer location Colon	12 Participants n=5 Participants
Cancer location Rectum	17 Participants n=5 Participants
Cancer location Colon and rectum	1 Participants n=5 Participants
pT-Stage pT1	4 Participants n=5 Participants
pT-Stage pT2	4 Participants n=5 Participants
pT-Stage pT3	16 Participants n=5 Participants
pT-Stage pT4	5 Participants n=5 Participants
pT-Stage pTX	1 Participants n=5 Participants
pN-Stage pN0	10 Participants n=5 Participants
pN-Stage pN1	14 Participants n=5 Participants
pN-Stage pN2	6 Participants n=5 Participants
Chemotherapy Adjuvant	19 Participants n=5 Participants
Chemotherapy Adjuvant and neoadjuvant	11 Participants n=5 Participants
Height	175 cm n=5 Participants
Weight	76 kg n=5 Participants
pM-Stage pM0	27 Participants n=5 Participants
pM-Stage pMX	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Total of all 30 participants enrolled

Evaluation of the feasibility measured in terms of training adherence during the first 12 weeks measured in actual participant-weeks in relation to the 360 planned participant-weeks during cycle 1 (week 1 to week 12)

Outcome measures

Measure	Physical Exercise n=360 Participant-weeks No treatment, only physical examinations accompanying physical exercise (defined exercise program)
Feasibility of Physical Activity After 12 Weeks (3 Months)	331 Participant-weeks

PRIMARY outcome

Timeframe: 6 months

Population: Total of all 30 participants enrolled

Evaluation of the feasibility measured in terms of training adherence during the weeks 13 to 26 measured in actual participant-weeks in relation to the planned 420 participant-weeks during cycle 2 (week 13 to week 26)

Outcome measures

Measure	Physical Exercise n=420 Participant-weeks No treatment, only physical examinations accompanying physical exercise (defined exercise program)
Feasibility of Physical Activity After 26 Weeks (6 Months)	277 Participant-weeks

PRIMARY outcome

Timeframe: 12 months

Population: Total of all 30 participants enrolled

Evaluation of the feasibility measured in terms of training adherence during the weeks 27 to 52 measured in actual participant-weeks in relation to the planned 780 participant-weeks during cycle 3 (week 27 to week 52)

Outcome measures

Measure	Physical Exercise n=780 Participant-weeks No treatment, only physical examinations accompanying physical exercise (defined exercise program)
Feasibility of Physical Activity After 52 Weeks (12 Months)	468 Participant-weeks

SECONDARY outcome

Timeframe: 3 months

Population: All participants with METs information

Evaluation by exercise ergometry and descriptively compared with the planned exercise ergometry after 12 weeks; measured in mean METs (metabolic equivalent of task) per week in relation to the planned mean 10 METs during cycle 1 (week 1 to week 12)

Outcome measures

Measure	Physical Exercise n=21 Participants No treatment, only physical examinations accompanying physical exercise (defined exercise program)
Exercise Ergometry Activity After 12 Weeks (3 Months)	9.43 kcal/kg/hour Standard Deviation 7.82

SECONDARY outcome

Timeframe: 6 months

Population: All participants with METs information

Evaluation by exercise ergometry and descriptively compared with the planned exercise ergometry after 26 weeks; measured in mean METs (metabolic equivalent of task) per week in relation to the planned mean 15 METs during cycle 2 (week 13 to week 26)

Outcome measures

Measure	Physical Exercise n=18 Participants No treatment, only physical examinations accompanying physical exercise (defined exercise program)
Exercise Ergometry Activity After 26 Weeks (6 Months)	12.7 kcal/kg/hour Standard Deviation 7.23

SECONDARY outcome

Timeframe: 12 months

Population: All participants with METs information

Evaluation by exercise ergometry and descriptively compared with the planned exercise ergometry after 52 weeks; measured in mean METs (metabolic equivalent of task) per week in relation to the planned mean 18 METs during cycle 3 (week 27 to week 52)

Outcome measures

Measure	Physical Exercise n=14 Participants No treatment, only physical examinations accompanying physical exercise (defined exercise program)
Exercise Ergometry Activity After 52 Weeks (12 Months)	11.27 kcal/kg/hour Standard Deviation 8.61

SECONDARY outcome

Timeframe: Day 1 (at screening)

Population: All participants with information on adiponectin

Evaluation of adiponectin at screening as baseline for a description of changes during the study

Outcome measures

Measure	Physical Exercise n=20 Participants No treatment, only physical examinations accompanying physical exercise (defined exercise program)
Adiponectin at Screening	9.93 μg/ml Standard Deviation 2.88

SECONDARY outcome

Timeframe: 3 months

Population: All participants with information on adiponectin

Evaluation of adiponectin after 12 weeks (3 months) for a description of changes during the study

Outcome measures

Measure	Physical Exercise n=19 Participants No treatment, only physical examinations accompanying physical exercise (defined exercise program)
Adiponectin After 12 Weeks (3 Months)	8.14 μg/ml Standard Deviation 3.79

SECONDARY outcome

Timeframe: 12 months

Population: All participants with information on adiponectin

Evaluation of adiponectin after 52 weeks (12 months) for a description of changes during the study

Outcome measures

Measure	Physical Exercise n=14 Participants No treatment, only physical examinations accompanying physical exercise (defined exercise program)
Adiponectin After 52 Weeks (12 Months)	9.31 μg/ml Standard Deviation 3.37

SECONDARY outcome

Timeframe: Day 1 (at screening)

Population: All participants with information on leptin

Evaluation of leptin at screening as baseline for a description of changes during the study

Outcome measures

Measure	Physical Exercise n=20 Participants No treatment, only physical examinations accompanying physical exercise (defined exercise program)
Leptin at Screening	36.02 ng/ml Standard Deviation 31.68

SECONDARY outcome

Timeframe: 3 months

Population: All participants with information on leptin

Evaluation of leptin after 12 weeks (3 months) for a description of changes during the study

Outcome measures

Measure	Physical Exercise n=19 Participants No treatment, only physical examinations accompanying physical exercise (defined exercise program)
Leptin After 12 Weeks (3 Months)	41.12 ng/ml Standard Deviation 43.07

SECONDARY outcome

Timeframe: 12 months

Population: All participants with information on leptin

Evaluation of leptin after 52 weeks (12 months) for a description of changes during the study

Outcome measures

Measure	Physical Exercise n=14 Participants No treatment, only physical examinations accompanying physical exercise (defined exercise program)
Leptin After 52 Weeks (12 Months)	42.5 ng/ml Standard Deviation 41.74

Adverse Events

Physical Exercise

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Physical Exercise n=30 participants at risk No treatment, only physical examinations accompanying physical exercise (defined exercise program)
Cardiac disorders Atrial fibrillation	3.3% 1/30 • Number of events 1 • 12 months
Cardiac disorders Heart pain	3.3% 1/30 • Number of events 2 • 12 months
General disorders Indisposition	3.3% 1/30 • Number of events 1 • 12 months

Additional Information

Trial Office Director

ABCSG (Austrian Breast & Colorectal Cancer Study Group)

Phone: +43 1 4089230

Email: info@abcsg.at

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place