N/A
Completed N=30
Physical Activity for Reduction of Recurrence Rate After Adjuvant Chemotherapy for Localised Colorectal Carcinoma
Source: ClinicalTrials.gov NCT01210313 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcomePrimary: Feasibility of Physical Activity After 12 Weeks (3 Months) — 331 Participant-weeks
Summary
* feasibility of physical activity
* increase of physical conversation
* Quality of Life (optional)
* vascular and metabolic effects
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Physical Activity After 12 Weeks (3 Months) |
331 | — |
| PRIMARY Feasibility of Physical Activity After 26 Weeks (6 Months) |
277 | — |
| PRIMARY Feasibility of Physical Activity After 52 Weeks (12 Months) |
468 | — |
| SECONDARY Exercise Ergometry Activity After 12 Weeks (3 Months) |
9.43 | — |
| SECONDARY Exercise Ergometry Activity After 26 Weeks (6 Months) |
12.7 | — |
| SECONDARY Exercise Ergometry Activity After 52 Weeks (12 Months) |
11.27 | — |
| SECONDARY Adiponectin at Screening |
9.93 | — |
| SECONDARY Adiponectin After 12 Weeks (3 Months) |
8.14 | — |
| SECONDARY Adiponectin After 52 Weeks (12 Months) |
9.31 | — |
| SECONDARY Leptin at Screening |
36.02 | — |
| SECONDARY Leptin After 12 Weeks (3 Months) |
41.12 | — |
| SECONDARY Leptin After 52 Weeks (12 Months) |
42.5 | — |
Eligibility Criteria
Inclusion Criteria
- complete resected, histologically confirmed adeno carcinoma of colon or rectal and condition after (neo-)adjuvant therapy either in (1) stage III or (2) stage II with risk factor
- 4-16 weeks after the end of an adjuvant chemotherapy
- ECOG 0,1
- Age > 18 years
- adequate liver-, nephro- and hemogram parameters
- physical eligibility
Exclusion Criteria
- significant comorbidities which exclude the participation
- evidence of local recurrence or distant metastases
- non-compliance of subject
- other malignancy within the last 5 years (except: skin basalioma, cervix carcinoma in situ)
- clinically significant cardiovascular diseases
- treatment with beta blocker without possibility of adjustment
- left bundle-branch block
- simultaneous chemotherapy or radiotherapy
- pregnancy
Data sourced from ClinicalTrials.gov (NCT01210313). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.