Physical Exercise for Patients With Head and Neck Cancer

NCT05988060 | Recruiting

• 1 other identifier: NL79549.028.21
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this trial within cohorts study is to determine and compare physical performance, muscle strength, fatigue, quality of life, body composition, nutritional status, physical activity, treatment tolerability of radiotherapy (RT), chemoradiation (CRT) or bioradiation (BRT), and healthcare related costs in patients with head and neck cancer (HNC) with and without a 10 week physical exercise intervention (PEI) during RT, CRT or BRT ((C/B)RT). Patients who were randomized in the PEI group and accepted the invitation to undergo the experimental intervention receive a PEI twice a week for 10 weeks. The PEI will be executed 6 to 7 weeks during and 3 to 4 weeks after (C/B)RT. Researchers will compare patients who undergo the PEI with patients who did not undergo the PEI to see if there is difference in physical performance, muscle strength, fatigue, Quality of Life, body composition, nutritional status, physical activity, treatment tolerability of (C/B)RT , and healthcare related costs in patients with Head and Neck Cancer (HNC) with and without a 10 week Physical Exercise Intervention (PEI) during (C/B)RT).

Conditions

Head and Neck Cancer

Keywords

head and neck cancer; chemo- or bioradiotherapy; physical exercise intervention; physical performance; trial within cohorts; TwiCs

Outcome Measures

Primary Outcomes (1)

• physical performance

  six minute walking test

  M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)

Secondary Outcomes (12)

• Muscle strength

  M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)

• Muscle strength

  M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)

• Muscle strength

  M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)

• Health Related Quality of Life

  M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)

• Health Related Quality of Life

  M0 (baseline/before (C/B)RT), M1 (12 weeks), M2 (6 months), M3 (12 months)

Study Arms (2)

Patients who were randomized in the PEI group and accepted the invitation

EXPERIMENTAL

The experimental intervention consist of a PEI for 10 weeks. The PEI will be executed 6 to 7 weeks during and 3 to 4 weeks after (C/B)RT.

Other: Experimental Intervention

Patients who were not randomized in the PEI group

NO INTERVENTION

Patients will receive usual care.

Interventions

Experimental Intervention OTHER

Patients who were randomized in the PEI group and accepted the invitation to undergo the experimental intervention receive a PEI for 10 weeks. The PEI will be executed 6 to 7 weeks during and 3 to 4 weeks after (C/B)RT. The PEI consists of a 60 minutes intervention twice a week and will be supervised by a physiotherapist specialized in oncology. Patients who receive the intervention also have to do home-based aerobic and muscle strength exercises by themselves three times a week.

Also known as: Physical Exercise Intervention

Patients who were randomized in the PEI group and accepted the invitation

Eligibility Criteria

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

You may qualify if:

• patients with HNC who are scheduled for (C/B)RT,
• ≥18 years of age,
• sufficient Dutch writing and reading skills,
• a Karnofsky performance status (KPS) \>60,
• able to walk ≥60m without a mobility aid, and
• no contraindication for physical activity as measured with the physical activity readiness questionnaire (PAR-Q).

You may not qualify if:

• recurrence of HNC and/or
• secondary HNC.

Sponsors & Collaborators

• Institute Verbeeten: lead
• Verbeeten Fonds: collaborator
• Stichting Fight Cancer: collaborator
• CZ Fonds: collaborator

Study Sites (1)

Instituut Verbeeten

Tilburg, North Brabant, 5042 SB, Netherlands

RECRUITING

Related Publications (1)

• Kriellaars Y, Vermaire JA, Beugeling M, Poorter R, Drijvers J, Speksnijder CM. The effect of physical exercise during radiotherapy on physical performance in patients with head and neck cancer: a trial within cohorts study protocol, the vital study. BMC Cancer. 2024 Apr 1;24(1):403. doi: 10.1186/s12885-024-12172-2.

  PMID: 38561708 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Yvette Kriellaars, Msc.

  Instituut Verbeeten

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Speksnijder, Dr.

CONTACT

+3188758040; C.M.Speksnijder@umcutrecht.nl

Jorine Vermaire, Dr.

CONTACT

+135947777; vermaire.j@bvi.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this study a TwiCs design will be used. The TwiCs design consists of an experimental intervention study within an observational longitudinal cohort. This design uses a staged-informed consent. Patients will be asked to participate in an observational longitudinal cohort study and will be informed about the design with the probability to be randomly invited for an experimental intervention which they can accept or refuse. When patients are willing to participate in the observational longitudinal cohort, an informed consent (IC) will be signed. Directly after cohort enrollment, all patients will be randomized.

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 14, 2023
• Study Start: November 9, 2022
• Primary Completion: November 9, 2025
• Study Completion (Estimated): November 9, 2026
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)