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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02557529
• Date of registration: 11/09/2015
• Prospective Registration: No
• Primary sponsor: Herlev Hospital
• Public title: Progressive Resistance Training in Head and Neck Cancer Patients During Concomitant Chemoradiotherapy
• Scientific title: Progressive Resistance Training in Head and Neck Cancer Patients During Concomitant Chemoradiotherapy - The DAHANCA 31 Study
• Date of first enrolment: August 2015
• Target sample size: 50
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02557529
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Denmark

Contacts

• Name: Julie Gehl
• Affiliation: Herlev Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- BMI below 20.5

- diabetes

- corticosteroid treatment for other diseases

- Tonsillectomy within the last week before inclusion.

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Head and Neck Neoplasms

Weight Loss

Intervention(s)

Behavioral: Diet diary

Behavioral: Progressive Resistance Training

Behavioral: physical activity

Primary Outcome(s)

Change in LBM (lean body mass) [Time Frame: at 12-weeks post PRT]

Secondary Outcome(s)

Cytokines [Time Frame: at 3, 6, 8, 10, and 12 weeks]

Physical activity [Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT]

Compliance to PRT program [Time Frame: at 12 weeks post PRT]

Patient satisfaction [Time Frame: at 12 weeks]

Fat mass [Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT]

Patient reported Quality of Life [Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT]

Change in LBM (lean body mass) [Time Frame: at 6 weeks, and 6 and 12 months post RT]

Muscle strength [Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT]

Percent of patients with feeding tubes [Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT]

Stair climb [Time Frame: at 6 and 12 weeks, 6 and 12 months]

arm curls [Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT]

Chair rise [Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT]

NK-cells [Time Frame: at 3 and 12 weeks]

Resumption of work [Time Frame: At 12 months follow-up]

Patient reported pain [Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT]

Percent relapses [Time Frame: at 12 months follow-up]

Muscle biopsies [Time Frame: at 6 and 12 weeks, and at 12 months follow-up]

Weight loss [Time Frame: at 6 and 12 weeks, and 6 and 12 months post RT]

Secondary ID(s)

DAHANCA 31

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Odense University Hospital

Danish Head and Neck Cancer Group

Aarhus University Hospital