Pedometer Intervention and Health Effects for Sedentary Colorectal Cancer Patients During Adjuvant Chemotherapy

Colorectal Cancer Clinical Trial

Official title:

Pedometer Intervention, Health Counseling, Symptom Management for Sedentary Colorectal Cancer Patients During Adjuvant Chemotherapy.Two-armed Randomized Phase II Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02522520
• Other study ID #: CIRE-15
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: September 2021

Study information

• Verified date: April 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Colorectal cancer is one of the most common cancers in Denmark, annually 4,200 men and women are diagnosed and approx. 2000 patients die of their colorectal cancer. As with other cancers, the risk of colorectal cancer increases with age, and the median age at diagnosis is 71 years. Improved treatment has increased the number of survivors with an expected 5-year survival rate of 50-60%. Characteristic of this group of patients is that at the time of diagnosis they often live with comorbidities and have limited leisure time physical activity.

There is evidence that rehabilitation in the form of physical exercise for cancer patients after their initial treatment has a positive effect on a number of physical and psychological parameter such as health-related quality of life, physical capacity and physical function, fatigue, anxiety and depression. However, the most frequently studied diagnosis group is women with breast cancer. Until now only few studies have evaluated the effects of physical activity among colorectal cancer patients receiving chemotherapy

The purpose of this study is: to examine the effect of two different training initiatives - 12 weeks progressive, high-intensity training versus low intensity exercise intervention - on physical, emotional and social habitus, in sedentary patients with colorectal cancer during adjuvant chemotherapy.

The hypothesis of the study are: 1. That both interventions will show a positive association between increased physical capacity (measured by aerobic capacity VO2-peak / peak oxygen uptake) and improved physical function, reduced fatigue and anxiety in the included sedentary colorectal cancer patients undergoing adjuvant chemotherapy.

Participants: Patients undergoing adjuvant chemotherapy for colorectal cancer who have self-reported physical activity level below the national recommended levels (less than 150 min/week of moderate leisure time physical activity, and exercises at least 20 minutes of strenuous physical activity twice a week).

Benefits and risks of participating: Possible benefits of the interventions: to reduce treatment related symptoms and side-effects, increase vitality and well-being and promote lifestyle changes among sedentary colorectal cancer patients receiving adjuvant chemotherapy. At participation in the interventions minor sports injuries may occur.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2021
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with colorectal cancer in adjuvant chemotherapy

• Age 18+ years

• WHO performance status of 0 or 1

• Undergone surgery at least 6 weeks ago

• Do not meet criteria for recommended physical activity level of 150 min / week of moderate leisure time physical activity, and exercises at least 20 minutes of strenuous physical activity twice a week.

Exclusion Criteria:

• Myocardial infarction within the past six months

• Symptomatic heart failure

• Known angina pectoris

• Contraindication for moderate to strenuous physical activity

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Pedometer intervention
12 weeks physical activity intervention (supervised/non-supervised)
• Pedometer + hospital based intervention
12 weeks physical activity intervention (supervised/non-supervised)

Device:
• Omron Walking Style pro. 20

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (5)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Copenhagen University Hospital at Herlev, Danish Cancer Society, Novo Nordisk A/S, TrygFonden, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum oxygen uptake - ( VO2 peak)	Assessed with objective physiological test	12 weeks
Secondary	Health related Quality of Life	Assessed by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, specifically for colon cancer patients	From baseline to 39 weeks
Secondary	Symptoms and side-effects	Assessed by MD Andersen symptom questionnaire and The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, chemotherapy-induced peripheral neuropathy	From baseline to 39 weeks
Secondary	Anxiety and Depression	Assessed by The Hospital Anxiety and Depression Scale	From baseline to 39 weeks
Secondary	Lifestyle factors	Assessed by smoking cessation, alcohol, diet	From baseline to 39 weeks
Secondary	Physical activity level	Assessed by the International Physical Activity Questionnaire	From baseline to 39 weeks
Secondary	Dual Energy X-ray Absorptiometry scan	Assessed by dual energy x-ray absorptiometry.	From baseline to 39 weeks
Secondary	Blood cholesterols	Assessed by blood samples	From baseline to 39 weeks
Secondary	Blood pressure / pulse	Assessed by Heart Rate Monitor during the hospital-based intervention	From 6 to 12 weeks
Secondary	Pedometer Step Count	Assessed by Omron Walking Style pro. 20 with electronic data transmission	From baseline to 12 weeks