Clinical trial · Interventional
Progressive Resistance Training in Head and Neck Cancer Patients During Concomitant Chemoradiotherapy
Progressive Resistance Training in Head and Neck Cancer Patients During Concomitant Chemoradiotherapy - The DAHANCA 31 Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow recruition
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Weight Loss | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diet diary | Behavioral | — | UNRESOLVED |
| physical activity | Behavioral | — | UNRESOLVED |
| Progressive Resistance Training | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Progressive Resistance Training
- description
- 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.
- interventionNames
- Behavioral: Progressive Resistance Training
- Behavioral: physical activity
- Behavioral: Diet diary
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- Control arm. Optional/voluntary physical activity performed on their own is registered, as well as diet diary.
- interventionNames
- Behavioral: physical activity
- Behavioral: Diet diary
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDLonkvist 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