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Preventive Physical Activity Intervention in Head and Neck Cancer

Primary Purpose

Head and Neck Neoplasms, Physical Inactivity

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Preventive physical exercise
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Head and Neck Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Head and neck cancer (tumors of the oropharynx, pharynx, hypopharynx and larynx)
  • Receiving radiohterapy (+/- chemotherapy) with curative intent

Exclusion Criteria:

  • Surgery due to head and neck cancer
  • Previous treatment for head and neck cancer
  • Tracheostomized patients
  • Inability to perform exercise intervention
  • Inability to perform part of 6-minute walking test
  • Inability to independently fill out questionnaires in Swedish
  • Previous neurologic or neuromuscular disease

Sites / Locations

  • Sahlgrenska University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Physical exercise intervention

Control

Arm Description

The physical activity intervention is based on national guidelines of physical activity in cancer rehabilitation. A physiotherapist together with each patient will develop individual adaptations to the exercise protocol, with suggestions on which type of exercise the participant is able to perform depending on their daily condition. Suggestions on physical activity for good, bad and in-between-days will be listed in collaboration with the participant, and the participant will report number of minutes/day in each of the 3 physical activity levels stated.

The control group will receive general advice on the importance of physical activity during oncologic treatment, according to local clinical standard.

Outcomes

Primary Outcome Measures

Objectively measured physical activity
Measured with an accelerometer. Measures time spent in different activities i minutes/day.
Subjectively measured physical activity - Saltin-Grimby
Measured with the Saltin-Grimby physical activity level scale and the International Physical Activity Questionnaire.
Subjectively measured physical activity (IPAQ)
Measured with the International Physical Activity Questionnaire

Secondary Outcome Measures

Health related quality of life (HRQL) using the EORTC QLQ-C30
Measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) core questionnaire (c30). Consists of 30 items divided into six functional domains (Physical, Role, Cognitive, Emotional, and Social Functioning and Global Quality of life), three symptom scales (Fatigue, Pain, and Nausea/Vomiting) and six single items (Constipation, Diarrhea, Insomnia, Dyspnea, Appetite Loss, and Financial Difficulties). All domains range from 0-100. For the functional domains a higher score indicates good function, while for all other domains a high score indicates a high prevalence of symtoms, i.e. worse HRQL.
Health related quality of life (HRQL) using the EORTC QLQ H&N35
Measured with the EORTC QLQ Head and neck module (HN35). It consists of 35 questions regarding symptoms more specific to the head and neck cancer population, and domain scores range from 0-100, where a higher score represents the prevalence of more symtoms, i.e. worse HRQL.
Trismus and jaw related symptoms
Patient Reported Outcomes (PRO) measured with Gothenburg Trismus Questionnaire (GTQ). The GTQ consists of 21 items divided into 3 domains; Jaw related problems, Eating limitations and Muscular tension and eight single items concerning facial pain, limitations in mouth opening and inabilities to function on social and working contexts. The GTQ domains range from 0-100 where 0 equals to absence of symtoms and 100 equals worst possible symptoms.
Dysphagia related symtoms
PRO measured with M.D Anderson Dysphagia Inventory (MDADI). This is a cancer-specific instrument measuring dysphagia, social function and quality of life in head and neck cancer patients. It consists of 19 items in four domains; emotional, physical, functional and global quality of life. The range for each subscale is 20-100 where 100 indicates best possible swallowing, i.e. better outcome.
Maximal Interincisal opening (MIO)
Jaw opening measured in millimeters
Body composition
Bioelectric impedance analysis.
Grip strength
Measured with the a hand dynamometer
6-minute walking test
Measures total walking distance during 6 minutes.

Full Information

First Posted
April 12, 2022
Last Updated
September 18, 2023
Sponsor
Sahlgrenska University Hospital, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT05432297
Brief Title
Preventive Physical Activity Intervention in Head and Neck Cancer
Official Title
Preventive Randomized Study Regarding Physical Activity Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer: the Effect of Preventive Intervention for Physical Activity, Function and Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 2, 2023 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The study includes patients with tumors of the oropharynx, larynx and hypopharynx scheduled to receive radiotherapy with curative intent (+/- chemotherapy). The patients will be randomized into either an intervention group (performing a preventive physical activity protocol before and during radiotherapy) or a control group not performing a specified physical exercise protocol. All patients will be in contact with with a speech language pathologist or a physical therapist weekly during radiotherapy. The study is expected to improve physical function and quality of life during and after oncologic treatment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms, Physical Inactivity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physical exercise intervention
Arm Type
Experimental
Arm Description
The physical activity intervention is based on national guidelines of physical activity in cancer rehabilitation. A physiotherapist together with each patient will develop individual adaptations to the exercise protocol, with suggestions on which type of exercise the participant is able to perform depending on their daily condition. Suggestions on physical activity for good, bad and in-between-days will be listed in collaboration with the participant, and the participant will report number of minutes/day in each of the 3 physical activity levels stated.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will receive general advice on the importance of physical activity during oncologic treatment, according to local clinical standard.
Intervention Type
Behavioral
Intervention Name(s)
Preventive physical exercise
Intervention Description
Daily physical activity depending on daily condition
Primary Outcome Measure Information:
Title
Objectively measured physical activity
Description
Measured with an accelerometer. Measures time spent in different activities i minutes/day.
Time Frame
Up to 12 months
Title
Subjectively measured physical activity - Saltin-Grimby
Description
Measured with the Saltin-Grimby physical activity level scale and the International Physical Activity Questionnaire.
Time Frame
Up to 12 months
Title
Subjectively measured physical activity (IPAQ)
Description
Measured with the International Physical Activity Questionnaire
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Health related quality of life (HRQL) using the EORTC QLQ-C30
Description
Measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) core questionnaire (c30). Consists of 30 items divided into six functional domains (Physical, Role, Cognitive, Emotional, and Social Functioning and Global Quality of life), three symptom scales (Fatigue, Pain, and Nausea/Vomiting) and six single items (Constipation, Diarrhea, Insomnia, Dyspnea, Appetite Loss, and Financial Difficulties). All domains range from 0-100. For the functional domains a higher score indicates good function, while for all other domains a high score indicates a high prevalence of symtoms, i.e. worse HRQL.
Time Frame
Up to 5 years post radiotherapy
Title
Health related quality of life (HRQL) using the EORTC QLQ H&N35
Description
Measured with the EORTC QLQ Head and neck module (HN35). It consists of 35 questions regarding symptoms more specific to the head and neck cancer population, and domain scores range from 0-100, where a higher score represents the prevalence of more symtoms, i.e. worse HRQL.
Time Frame
Up to 5 years post radiotherapy
Title
Trismus and jaw related symptoms
Description
Patient Reported Outcomes (PRO) measured with Gothenburg Trismus Questionnaire (GTQ). The GTQ consists of 21 items divided into 3 domains; Jaw related problems, Eating limitations and Muscular tension and eight single items concerning facial pain, limitations in mouth opening and inabilities to function on social and working contexts. The GTQ domains range from 0-100 where 0 equals to absence of symtoms and 100 equals worst possible symptoms.
Time Frame
Up to 5 years post radiotherapy
Title
Dysphagia related symtoms
Description
PRO measured with M.D Anderson Dysphagia Inventory (MDADI). This is a cancer-specific instrument measuring dysphagia, social function and quality of life in head and neck cancer patients. It consists of 19 items in four domains; emotional, physical, functional and global quality of life. The range for each subscale is 20-100 where 100 indicates best possible swallowing, i.e. better outcome.
Time Frame
Up to 5 years post radiotherapy
Title
Maximal Interincisal opening (MIO)
Description
Jaw opening measured in millimeters
Time Frame
Up to 5 years post radiotherapy
Title
Body composition
Description
Bioelectric impedance analysis.
Time Frame
Up to 12 months post radiotherapy
Title
Grip strength
Description
Measured with the a hand dynamometer
Time Frame
Up to 12 months post radiotherapy
Title
6-minute walking test
Description
Measures total walking distance during 6 minutes.
Time Frame
Up to 12 months post radiotherapy
Other Pre-specified Outcome Measures:
Title
Cost
Description
The cost of intervention compared to usual care. Costs in Swedish crowns (SEK) for the intervention and all visits to healthcare during 5 years will be recorded.
Time Frame
Up to 5 years post radiotherapy
Title
Quality of life for cost-effectiveness analysis
Description
The outcomes of intervention compared to usual care using European Quality of life 5 dimensions (EQ5D).
Time Frame
Up to 5 years post radiotherapy
Title
Quality Adjusted Life Years (QALY)
Description
QALY is a measurement that combines health-related quality of life (HRQL) and life expectancy in one index. The index range between 0 and 1, where 0 equals death and 1 represents perfect health. Thus, 1 QALY corresponds to 1 year of perfect health. This is calculated using the EQ-5D.
Time Frame
Up to 5 years post radiotherapy
Title
Incremental Cost Effectiveness Ratio (ICER)
Description
Incremental cost for each QALY for the intervention group will be calculated using a Markov model which combines the costs and EQ-5D. The ICER will then be compared to the maximum willingness to pay level which is SEK 500,000 (€55,000) according to the Swedish National Board of Health and Welfare.
Time Frame
Up to 5 years post radiotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Head and neck cancer (tumors of the oropharynx, pharynx, hypopharynx and larynx) Receiving radiohterapy (+/- chemotherapy) with curative intent Exclusion Criteria: Surgery due to head and neck cancer Previous treatment for head and neck cancer Tracheostomized patients Inability to perform exercise intervention Inability to perform part of 6-minute walking test Inability to independently fill out questionnaires in Swedish Previous neurologic or neuromuscular disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Tuomi, PhD
Phone
+46313421000
Email
tuomi.lisa@gu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Tuomi, PhD
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
41345
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Tuomi

12. IPD Sharing Statement

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Preventive Physical Activity Intervention in Head and Neck Cancer

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