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

Colorectal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01210313
• Other study ID #: ABCSG C07
• Secondary ID: EXERCISE
• Status: Completed
• Start date: October 2010
• Est. completion date: April 2013

Study information

• Verified date: June 2022
• Source: Austrian Breast & Colorectal Cancer Study Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

• feasibility of physical activity

• increase of physical conversation

• Quality of Life (optional)

• vascular and metabolic effects

Description:

In this phase II pilot project the feasibility of a defined medical physical activity should be verified for increased physical conversation. The study is conducted multicentric (single group) with a study population of 30 patients. After completion of adjuvant chemotherapy the patients will participate a defined physical training, 3 times per week within a time period of 52 weeks. Planned study duration 2 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Colorectal Carcinoma
• Colorectal Neoplasms
• Recurrence

Locations

Country	Name	City	State
Austria	Medical University Innsbruck, Internal Medicine	Innsbruck	Tyrol
Austria	District Hospital Kufstein	Kufstein	Tyrol
Austria	AKH Linz	Linz	Upper Austria
Austria	State Hospital Rankweil	Rankweil	Vorarlberg
Austria	Paracelsus Medical University Salzburg-Oncology, Coop. Group	Salzburg
Austria	Hospital BHB St. Veit/Glan, Surgery	St. Veit a. d. Glan	Carinthia
Austria	Klinikum Wels-Grieskirchen	Wels	Upper Austria

Sponsors (1)

Lead Sponsor	Collaborator
Austrian Breast & Colorectal Cancer Study Group

Country where clinical trial is conducted

Austria, 

References & Publications (8)

Demark-Wahnefried W. Cancer survival: time to get moving? Data accumulate suggesting a link between physical activity and cancer survival. J Clin Oncol. 2006 Aug 1;24(22):3517-8. Epub 2006 Jul 5. — View Citation

Haber Paul. Leitfaden zur medizinischen Trainingsberatung - Rehabilitation bis Leistungssport. 3. Auflage 2009; Springer Wien New York

Hoeger W, Hoeger S. Principles and Labs for Physical Fitness. Morton Publishing Company, first edition 1999

Holmes MD, Chen WY, Feskanich D, Kroenke CH, Colditz GA. Physical activity and survival after breast cancer diagnosis. JAMA. 2005 May 25;293(20):2479-86. — View Citation

Jackson AS, Pollock ML. Generalized equations for predicting body density of men. Br J Nutr. 1978 Nov;40(3):497-504. — View Citation

Meyerhardt JA, Giovannucci EL, Holmes MD, Chan AT, Chan JA, Colditz GA, Fuchs CS. Physical activity and survival after colorectal cancer diagnosis. J Clin Oncol. 2006 Aug 1;24(22):3527-34. Epub 2006 Jul 5. — View Citation

Meyerhardt JA, Heseltine D, Niedzwiecki D, Hollis D, Saltz LB, Mayer RJ, Thomas J, Nelson H, Whittom R, Hantel A, Schilsky RL, Fuchs CS. Impact of physical activity on cancer recurrence and survival in patients with stage III colon cancer: findings from C — View Citation

O'Donovan G, Owen A, Bird SR, Kearney EM, Nevill AM, Jones DW, Woolf-May K. Changes in cardiorespiratory fitness and coronary heart disease risk factors following 24 wk of moderate- or high-intensity exercise of equal energy cost. J Appl Physiol (1985). 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility of physical activity	evaluation by frequency and duration of training interruptions or training discontinuations	after 3 months
Primary	feasibility of physical activity	evaluation by frequency and duration of training interruptions or training discontinuations	after 6 months
Primary	feasibility of physical activity	evaluation by frequency and duration of training interruptions or training discontinuations	after 12 months
Secondary	increase of physical efficiency	evaluation by exercise ergometry which will be compared with baseline exercise ergometry	after 3 months
Secondary	increase of physical efficiency	evaluation by exercise ergometry which will be compared with baseline exercise ergometry	after 6 months
Secondary	increase of physical efficiency	evaluation by exercise ergometry which will be compared with baseline exercise ergometry	after 12 months
Secondary	Quality of Life scores	optional evaluation by EORTC QLQ-C30 in several trial sites	study start
Secondary	Quality of Life scores	optional evaluation by EORTC QLQ-C30 in several trial sites	after 3 months
Secondary	Quality of Life scores	optional evaluation by EORTC QLQ-C30 in several trial sites	after 6 months
Secondary	Quality of Life scores	optional evaluation by EORTC QLQ-C30 in several trial sites	after 9 months
Secondary	Quality of Life scores	optional evaluation by EORTC QLQ-C30 in several trial sites	after 12 months
Secondary	vascular and metabolic effects	10mL blood sample (EDTA) for analyzing of vascular and metabolic effects due to a structured training program after tumour disease	study start
Secondary	vascular and metabolic effects	10mL blood sample (EDTA) for analyzing of vascular and metabolic effects due to a structured training program after tumour disease	after 3 months
Secondary	vascular and metabolic effects	10mL blood sample (EDTA) for analyzing of vascular and metabolic effects due to a structured training program after tumour disease	after 12 months
Secondary	changes of cytokines and adiponectines	10mL blood sample (EDTA) for analyzing of changes of cytokines and adiponectines due to a structured training program after tumour disease	study start
Secondary	changes of cytokines and adiponectines	10mL blood sample (EDTA) for analyzing of changes of cytokines and adiponectines due to a structured training program after tumour disease	after 3 months
Secondary	changes of cytokines and adiponectines	10mL blood sample (EDTA) for analyzing of changes of cytokines and adiponectines due to a structured training program after tumour disease	after 12 months
Secondary	gen- and metabolic signs	10mL blood sample (EDTA) for analyzing of gen- and metabolic signs due to a structured training program after tumour disease	study start
Secondary	gen- and metabolic signs	10mL blood sample (EDTA) for analyzing of gen- and metabolic signs due to a structured training program after tumour disease	after 3 months
Secondary	gen- and metabolic signs	10mL blood sample (EDTA) for analyzing of gen- and metabolic signs due to a structured training program after tumour disease	after 12 months