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

NCT03252821 | Completed

• 1 other identifier: 1
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer; Head and Neck Cancer; Rectum Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change in functional capacity

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

• Change in quality of life

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

• Change in sleep disturbances

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

• Change in somnolence syndrome

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

• Change in insomnia

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

Study Arms (3)

High-intensity aerobic training group

EXPERIMENTAL

High intensity interval training

Behavioral: High-intensity interval training

Resistance training group

ACTIVE COMPARATOR

Muscle strengthening

Behavioral: Resistance training

Control group

NO INTERVENTION

Usual care

Interventions

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.

High-intensity aerobic training group

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).

Resistance training group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• uncontrolled cardiac, hypertensive or pulmonary diseases,
• uncontrolled insulin-dependent diabetes mellitus,
• neuropsychiatric disorders or orthopaedic conditions that would impair exercise participation
• abnormal electrocardiogram.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Related Publications (1)

• Piraux E, Reychler G, Vancraeynest D, Geets X, Leonard D, Caty G. High-intensity aerobic interval training and resistance training are feasible in rectal cancer patients undergoing chemoradiotherapy: a feasibility randomized controlled study. Rep Pract Oncol Radiother. 2022 May 19;27(2):198-208. doi: 10.5603/RPOR.a2022.0036. eCollection 2022.

  PMID: 36299392 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Head and Neck Neoplasms; Rectal Neoplasms

Interventions

High-Intensity Interval Training; Resistance Training

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 17, 2017
• Study Start: August 15, 2017
• Primary Completion: September 1, 2019
• Study Completion: September 20, 2019
• Last Updated: March 17, 2020

Record last verified: 2020-03

Locations

BE (1)