NCT03524755

Physical Exercise for Patients Who Suffer From Weight Loss Due to Head and Neck Cancer Undergoing Medical Treatment

Completed NA Last updated 15 May 2018

What this trial tests

NA trial testing Exercise in Head and Neck Cancer in 20 participants. Completed in 7 May 2015.

Timeline

10 July 2013

Primary endpoint
7 May 2015

7 May 2015

Quick facts

Lead sponsor	Ludwig-Maximilians - University of Munich
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	10 July 2013
Primary completion	7 May 2015
Estimated completion	7 May 2015

Drugs / interventions tested

• Exercise

Conditions studied

• Head and Neck Cancer — all drugs for Head and Neck Cancer →
• Cachexia; Cancer — all drugs for Cachexia; Cancer →
• Resistance Training — all drugs for Resistance Training →

Sponsor

Ludwig-Maximilians - University of Munich

Who can join

18 and older, any sex, with Head and Neck Cancer or Cachexia; Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Cancer cachexia is a prevalent symptom of head and neck neoplasms. The reduction in skeletal muscle mass is one of the main characteristics which can lead to poor physical functioning. The purpose of this study was to determine the feasibility of progressive resistance training in cachectic head and neck cancer patients during radiotherapy in a pilot randomized controlled design.

Baseline data for all participants were ascertained via medical records and patient interview. This included demographic information, Union internationale contre le cancer-status (UICC-status), comorbidities and the results of blood samples. Outcomes were measured at admission. One study coordinator completed all assessments to enhance patient compliance. Body weight loss percentage was calculated via the individuals' body weight 6 months before (in retrospect) and the current body weight. Participants completed two questionnaires: The Multidimensional Fatigue Inventory and the Functional Assessment of Anorexia/Cachexia Therapy questionnaire. Six-Minute Walk Test was applied. To document changes in muscle force, strength of the functional muscle group for elbow flexion in supine position as well as of knee extension in sitting position (in each case right and left) was tested via hand-held dynamometry for isometric maximal muscle strength. Bioelectrical impedance analysis was executed to assess the adaption in body composition.

The exercise intervention was undertaken in the hospitals department of physical and rehabilitation medicine and based on standardized but individualized training protocols. It consisted of a warm up period for 5 minutes on a bicycle ergometer or an upper body cycle with individual selectable wattage. A leg press, a latissimus pull-down and a chest press formed the three equipment supported core exercises. All exercises were performed with 8-12 repetitions and 3 sets.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Progressive resistance training in cachectic head and neck cancer patients undergoing radiotherapy: a randomized controlled pilot feasibility trial.
   Grote M, Maihöfer C, Weigl M, Davies-Knorr P, et al · · 2018 · cited 60× · PMID 30400971 · DOI 10.1186/s13014-018-1157-0