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NCT Number: NCT03252821

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

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.

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Key information

Conditions

Prostate Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Head and Neck Cancer Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Rectal Diseases Rectal Neoplasms Rectum Cancer Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High-intensity interval training

Behavioral

High-intensity interval training sessions will be conducted on cycle ergometers or treadmill with heart rate measured throughout each session.

Resistance training

Behavioral

Resistance exercise will be performed on eight exercises targeting major muscle groups at 60% to 85% of their estimated one-repetition maximum (1RM).

Primary outcomes

  1. Change in fatigue

    Time frame: Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)

    Fatigue is measured by FACIT-fatigue questionnaire

Secondary outcomes

  1. Change in functional capacity

    Time frame: Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)

    Functional capacity is measured by 6-minute walk test

  2. Change in quality of life

    Time frame: Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)

    Quality of life is measured by Functional Assessment of Cancer Therapy-General

  3. Change in sleep disturbances

    Time frame: Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)

    Sleep disturbances are measured by Pittsburgh Sleep Quality Index

  4. Change in somnolence syndrome

    Time frame: Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)

    Somnolence syndrome is measured by Epworth Sleepiness Scale

  5. Change in insomnia

    Time frame: Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)

    Insomnia is measured by Insomnia Severity Index

  6. Change in depression symptoms

    Time frame: Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)

    Depression symptoms are measured by Center for Epidemiologic Studies Depression Scale

  7. Change in executive functions

    Time frame: Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)

    Executive functions is measured by the Trail Making Test

  8. Change in dyspnea

    Time frame: Assessments at baseline and 5 weeks (rectum cancer) or 7 weeks (head and neck cancer) or 8 weeks (prostate cancer)

    Dyspnea is measured by Multidimensional Dyspnea Profile

  9. Adherence

    Time frame: Weekly through the intervention (during 8 weeks)

    Percentage of completed sessions

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 17, 2017
Registry last updated
Mar 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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