Effects of High-intensity Training Compared to Resistance Training in Cancer Patients Undergoing Radiotherapy

Prostate Cancer Clinical Trial

Official title:

Effects of High-intensity Training Compared to Resistance Training in Cancer Patients Undergoing Radiotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03252821
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• Start date: August 15, 2017
• Est. completion date: September 20, 2019

Study information

• Verified date: March 2020
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to assess the impact of a high-intensity aerobic training and resistance training on fatigue in prostate, head and neck and rectum cancer patients undergoing radiotherapy.

A three-arm randomized controlled trial will be conducted. Patients will be randomised into either a high-intensity aerobic training group or a resistance training group or a control group. Participants in the training groups will exercised for five to eight weeks. Exercise sessions will be take place 3 days per week under the supervision of an experienced therapist. Subjects will be assessed at baseline and post-intervention. The primary outcome will be fatigue measured using the FACIT-fatigue questionnaire. The secondary outcomes will be: functional capacity, quality of life, executive functions, sleep disturbances, somnolence syndrome, insomnia, depression symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: September 20, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria :

• a primary diagnosis of prostate cancer, head and neck cancer (oral cavity, pharynx, larynx, nasal cavity/sinuses, or salivary gland) or rectum cancer;

• age over 18 years;

• no distant metastases and/or disease progression;

• at least 25 scheduled radiation treatments (5 weeks);

• ability to read, write, and speak French.

Exclusion criteria :

• uncontrolled cardiac, hypertensive or pulmonary diseases,

• uncontrolled insulin-dependent diabetes mellitus,

• neuropsychiatric disorders or orthopaedic conditions that would impair exercise participation

• abnormal electrocardiogram.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Prostate Cancer
• Rectal Neoplasms
• Rectum Cancer

Intervention

Behavioral:
• High-intensity interval training
High-intensity interval training sessions will be conducted on cycle ergometers or treadmill with heart rate measured throughout each session.
• Resistance training
Resistance exercise will be performed on eight exercises targeting major muscle groups at 60% to 85% of their estimated one-repetition maximum (1RM).

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in fatigue	Fatigue is measured by FACIT-fatigue questionnaire	Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
Secondary	Change in functional capacity	Functional capacity is measured by 6-minute walk test	Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
Secondary	Change in quality of life	Quality of life is measured by Functional Assessment of Cancer Therapy-General	Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
Secondary	Change in sleep disturbances	Sleep disturbances are measured by Pittsburgh Sleep Quality Index	Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
Secondary	Change in somnolence syndrome	Somnolence syndrome is measured by Epworth Sleepiness Scale	Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
Secondary	Change in insomnia	Insomnia is measured by Insomnia Severity Index	Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
Secondary	Change in depression symptoms	Depression symptoms are measured by Center for Epidemiologic Studies Depression Scale	Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
Secondary	Change in executive functions	Executive functions is measured by the Trail Making Test	Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
Secondary	Change in dyspnea	Dyspnea is measured by Multidimensional Dyspnea Profile	Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)
Secondary	Adherence	Percentage of completed sessions	Weekly through the intervention (during 8 weeks)