Pre-habilitation of Patients With Head and Neck Cancer

NCT02385929 | Completed DMC

• 2 other identifiers: H-2-2014-074R108-A6969-14-S31
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to explore whether early initiated physical exercise concurrent with a swallowing and mouth opening exercise program will have a positive effect on swallowing function and other quality of life aspects in patients treated with radiotherapy for head and neck cancer. The investigators hypothesize that patients who complete the program will have improved swallowing function and physical function one year after completing their treatment compared to patients who do not participate in the training program.

Conditions

Head and Neck Cancer

Keywords

Head and Neck Cancer; Intervention; Rehabilitation; Late Effects; Dysphagia

Outcome Measures

Primary Outcomes (1)

• Swallowing function measured by penetration aspiration scale (PAS) during a Fiber Endoscopic Evaluation of Swallowing (FEES).

  To investigate the change in swallowing function among patients in intervention- and the control group from baseline to 14 and 58 weeks follow up and the difference in change between intervention - and the control group.

  Baseline, 14 weeks and 58 weeks. Participants will be followed up till 12 months after they finalize their radiotherapy, an expected average of 58 weeks from baseline.

Secondary Outcomes (12)

• Level of fatigue by the EORCT QLQ-C30 3-point fatigue subscale.

  baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks.

• Maximal Interincisal Distance (MID) by Therabite Range of Motion (ROM) scale

  baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks.

• Dysphagia related quality of life by M.D. Anderson Dysphagia Inventory (MDADI)

  baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks.

• Health related quality of Life by the European Organisation for Research and Treatment of Cancer (EORCT) Quality if Life Questionnaire (QLQ)-30 and EORCT QLQ - H&N35

  baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks.

• Level of oral intake by Functional Oral Intake Scale (FOIS)

  baseline, 6 weeks, 14 weeks, 28 weeks and 58 weeks.

Study Arms (2)

Swallowing therapy & resistance training

EXPERIMENTAL

Mouth opening and swallowing exercise intervention by occupational therapist for half an hour 3 times a week for 5-6 weeks during radiotherapy. Progressive resistance training by physiotherapist for 1 hour twice weekly for 5-6 weeks during radiotherapy.

Behavioral: Swallowing therapy & resistance training

Standard Care

NO INTERVENTION

Patients in this arm are randomized to usual care / control group

Interventions

Swallowing therapy & resistance training BEHAVIORAL

i) Individual instructions in swallowing and mouth opening exercises 3 days per week by occupational therapist throughout radiotherapy, ii) Progressive resistance training twice weekly by physiotherapist, either individually or group based, throughout radiotherapy, iii) Daily home-based swallowing and mouth opening exercises from beginning of treatment until 2 months after end-of-treatment. iv) Weekly follow-up phone contacts with occupational therapists from end-of-treatment and 2 months onwards.

Swallowing therapy & resistance training

Eligibility Criteria

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

You may qualify if:

• Histological proven cancer in one or more of the following areas: larynx, hypopharynx, oropharynx, cavi oris, or unknown primary tumor
• Set to curative radiotherapy with or without concurrent chemotherapy for treatment of cancer in the head and neck region in accordance with the Danish Head and Neck Cancer Group (DAHANCA) guidelines
• Fully self-reliant
• Danish skills, oral and written
• Informed consent

You may not qualify if:

• Previously received treatment for head and neck cancer (radiotherapy, chemotherapy and/or surgery).
• Pregnancy
• ECOG performance status \> 2
• Presence of psychological-, family-, sociological- or geographical issues that could prevent the patient from completing the intervention
• Simultaneous or previous illness or conditions that could prevent the patient's ability to complete the intervention.

Sponsors & Collaborators

• Irene Wessel: lead
• Danish Cancer Society: collaborator
• Danish Association of Occupational Therapist: collaborator
• Rigshospitalet, Denmark: collaborator
• Danish Cancer Research Foundation: collaborator

Study Sites (2)

Næstved Sygehus

Næstved, Region Sjælland, 4700, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (4)

• Hajdu SF, Wessel I, Johansen C, Kristensen CA, Kadkhoda ZT, Plaschke CC, Dalton SO. Swallowing therapy and progressive resistance training in head and neck cancer patients undergoing radiotherapy treatment: randomized control trial protocol and preliminary data. Acta Oncol. 2017 Feb;56(2):354-359. doi: 10.1080/0284186X.2016.1269193.

  PMID: 28206871 BACKGROUND

• Hajdu SF, Plaschke CC, Johansen C, Dalton SO, Wessel I. Cross-Cultural Translation, Adaptation and Reliability of the Danish M. D. Andeson Dysphagia Inventory (MDADI) in Patients with Head and Neck Cancer. Dysphagia. 2017 Aug;32(4):472-479. doi: 10.1007/s00455-017-9785-3. Epub 2017 Mar 7.

  PMID: 28271296 BACKGROUND

• Fredslund SV, Hogdal N, Christensen MB, Wessel I. Dysphagia training after head and neck cancer fails to follow legislation and national recommendations. Dan Med J. 2015 May;62(5):A5067.

  PMID: 26050828 BACKGROUND

• Hajdu SF, Christensen MB, Kristensen MO, Wessel I, Johansen C, Dalton S. Adherence to preventive swallowing exercises for head and neck cancer patients undergoing (chemo)radiotherapy treatment. Acta Oncol. 2019 May;58(5):658-664. doi: 10.1080/0284186X.2018.1563715. Epub 2019 Jan 30.

  PMID: 30698049 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Deglutition Disorders

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Sara F Hajdú, M.Sc

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

• Susanne O Dalton, professor

  Danish Cancer Society

  PRINCIPAL INVESTIGATOR

• Christoffer Johansen, professor

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

• Irene Wessel, MD, phd

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant, ph.d., associate professor

Study Record Dates

• First Submitted: February 9, 2015
• First Posted: March 11, 2015
• Study Start: May 11, 2015
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: March 27, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)