Progressive Resistance Training in Head and Neck Cancer Patients During Concomitant Chemoradiotherapy

NCT02557529 | Terminated

• 1 other identifier: DAHANCA 31
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

72 patients with head and neck cancer, undergoing primary treatment with radiation therapy and concomitant weekly cisplatin, will be recruited to this multicentre trial. Randomized 1:1 to either 12-week progressive resistance training (PRT) program or control arm, starting together with concomitant chemoradiotherapy (CCRT) Stratified by centre, gender, p16-status and body mass index (BMI) below or above 30. Primary endpoint is difference in change in lean body mass (LBM) between the groups and the endpoint is reduction of LBM loss in intervention arm by 25% compared to control. Secondary endpoints include side-effects to treatment, change in body composition, physical function and strength, and compliance to PRT. Questionnaires on QoL, diet, voluntary exercise and work affiliation will also be registered. Blood samples for explorative analyses will be drawn and optional muscle biopsies drawn for proteomics analyses and histological analyses.

Conditions

Head and Neck Neoplasms; Weight Loss

Keywords

Head and Neck Cancer; Concomitant chemoradiotherapy; Exercise Training; Progressive Resistance Training; Weight loss; Lean Body Mass; Body Composition

Outcome Measures

Primary Outcomes (1)

• Change in LBM (lean body mass)

  change in kilograms

  at 12-weeks post PRT

Secondary Outcomes (18)

• Change in LBM (lean body mass)

  at 6 weeks, and 6 and 12 months post RT

• Fat mass

  at 6 and 12 weeks, and 6 and 12 months post RT

• Weight loss

  at 6 and 12 weeks, and 6 and 12 months post RT

• Patient reported pain

  at 6 and 12 weeks, and 6 and 12 months post RT

• Patient reported Quality of Life

  at 6 and 12 weeks, and 6 and 12 months post RT

Study Arms (2)

Progressive Resistance Training

EXPERIMENTAL

12 weeks progressive resistance training (PRT) during and after concomitant chemoradiotherapy. Also optional/voluntary physical activity performed on their own is registered, as well as diet diary.

Behavioral: Progressive Resistance Training; Behavioral: physical activity; Behavioral: Diet diary

Control

ACTIVE COMPARATOR

Control arm. Optional/voluntary physical activity performed on their own is registered, as well as diet diary.

Behavioral: physical activity; Behavioral: Diet diary

Interventions

Progressive Resistance Training BEHAVIORAL

12 weeks supervised resistance training program. Details of the program: 12 weeks, 3 sessions per week, 7 exercises in training machines (leg press, leg curl, hamstring curl, chest press, lateral pull down, sit-ups and back extensions). In general 2-3 sets of 8-15 repetitions will be performed following a progression plan starting with more repetitions at lower intensity progressing to fewer repetitions at higher intensity during the 12-week period (American College of Sports Medicine Position Stand)

Progressive Resistance Training

physical activity BEHAVIORAL

Weekly diary of performed physical activity using the Physical Activity Score (PAS) during the 12-weeks intervention

Also known as: Diary of performed physical activity

Control; Progressive Resistance Training

Diet diary BEHAVIORAL

Weekly diet diary during the 12-weeks intervention

Control; Progressive Resistance Training

Eligibility Criteria

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

You may qualify if:

• Patients with biopsy verified head and neck squamous cell carcinoma referred for primary curatively intended treatment.
• Candidates for concomitant chemoradiotherapy (2Gyx33-34; 6F/W; weekly cisplatin 40mg/m2, max. 70 mg/weekly) according to Danish Head and Neck Cancer Group (DAHANCA) guidelines (T1-4, N1-3, M0)
• Performance status 0-1
• At least 18 years of age.

You may not qualify if:

• BMI below 20.5
• diabetes
• corticosteroid treatment for other diseases
• hemoglobin below 6 mmol/l
• leucocytes below 2.5 x 10\^9 /l
• thrombocytes below 50 x 10\^9 /l
• comorbidities, social, familial or geographical conditions, that could compromise attendance or results

Sponsors & Collaborators

• Herlev Hospital: lead
• Aarhus University Hospital: collaborator
• Odense University Hospital: collaborator
• Danish Head and Neck Cancer Group: collaborator

Study Sites (1)

Department of Oncology, Copenhagen University hospital, Herlev

Herlev, 2730, Denmark

Location

Related Publications (1)

• Lonkvist CK, Lonbro S, Vinther A, Zerahn B, Rosenbom E, Primdahl H, Hojman P, Gehl J. Progressive resistance training in head and neck cancer patients during concomitant chemoradiotherapy -- design of the DAHANCA 31 randomized trial. BMC Cancer. 2017 Jun 3;17(1):400. doi: 10.1186/s12885-017-3388-0.

  PMID: 28578654 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms; Weight Loss

Interventions

Exercise; Diet Records

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Records; Organization and Administration; Health Services Administration

Study Officials

• Julie Gehl

  Herlev Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Dr. Med. Sci.

Study Record Dates

• First Submitted: September 11, 2015
• First Posted: September 23, 2015
• Study Start: August 1, 2015
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: May 27, 2020

Record last verified: 2020-05

Locations

DK (1)