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Completed

NCT Number: NCT04433793

Yoga Intervention for Reducing Fatigue in Cancer Patients

Cancer patients suffer from severe exhaustion and tiredness that is disproportionate to previous efforts and that cannot be completely reduced by sleep. The effectiveness of an 8 week yoga therapy (one hour a week) in patients with different cancer types on self-reported fatigue will be tested.

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Key information

Conditions

Fatigue Cancer Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Würzburg, Interdisciplinary Centre, Palliativ Medicine

Würzburg, Bavaria, 97080, Germany

About this study

Almost 90% of cancer patients suffer from symptoms of fatigue during treatment. Supporting treatments are increasingly used to alleviate the burden of fatigue. This study examines the short-term effects of yoga on fatigue, depression and quality of life. The aim of this study will evaluate the efficacy of yoga for cancer patients with mixed diagnoses reporting fatigue. We will randomly allocate 124 patients to an intervention group (N=62) receiving yoga and a wait-list control group (N=62) receiving yoga 9 weeks later. The yoga therapy will be performed in weekly sessions of 60 minutes each for 8 weeks. The primary outcome will be self-reported fatigue symptoms. Secondary outcome will be depression and Quality of life

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • oncological disease
  • planned to undergo cancer related treatment at radiotherapy outpatient clinic or the interdisciplinary oncological therapy outpatient clinic
  • reported fatigue symptoms: (intensity ≥4, impairment ≥ 5).

Exclusion criteria

  • insufficient knowledge of German
  • severe emotional or physical impairment
  • more than 50km distance to the university hospital which would require travelling.

Treatment and study plan

Yoga therapy

Behavioral

One yoga session will last one hour. It consists of physical exercises (asanas), conscious breathing (Pranayama) and deep relaxation (Savasana). The subsequent body exercises are structured from lying to sitting to standing. The following sequence of exercises will be repeated in each yoga unit: 1) Relaxation: conscious breathing, body scan, mindfulness 2) Vein pump 3) Pelvis and back rotation (adapted variation of the "nakrasana") 4) Pelvis opening (adapted variation of the "supta baddha konasana") 5) Shoulder bridge ("setu bandha sarvangasana) 6) Forward folds (Paschimottanasana and variations with Pranayama) 7) Backbend: intense east stretch (Purvottasana) 8) Diagonal static yoga cat (Majariasana 1 and resting pose) 9) Standing exercise 10) Upward Salute(Urdhva Hastasana) 11) Warrior 1 (Virabhadrasana 1) 12) Warrior 3 (Virabhadrasana 3) 13) Tree (Vrkasana variation) 14) Relaxation (Savasana).

Primary outcomes

  1. Changes from self-reported fatigue after participation in yoga therapy.

    Time frame: T0: At the beginning of the study, T1: after 9 weeks

    Self-reported cancer related fatigue; measured with: European Organisation for Research and Treatment of Cancer - Quality of life Questionnaire - Fatigue 13 (EORTC-QLQ-FA13); Scale 1-4; Higher scores mean a higher burden of fatigue

Secondary outcomes

  1. Changes from Quality of life in cancer patients

    Time frame: T0: At the beginning of the study, T1: after 9 weeks

    self-reported Quality of life in cancer patients, measured with European Organisation for Research and Treatment of Cancer - Quality of life Questionnaire -Cancer 15 Palliativ (EORTC-QLQ-C15-Pal); Item 1- 14: Scale 1-4; Higher scores represent lower quality of life, Item 15: Scale 1-7; a higher value represents higher Overall Quality of life

  2. Changes from Depression

    Time frame: T0: At the beginning of the study, T1: after 9 weeks

    self reported Depression, measured with patient health questionnaire -9 (PHQ-9); Scale: 1-4; higher score represents higher burden of depression

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Collaborators

  • German Cancer Aid

Registry information

Official study title

Yoga Intervention and Reminder E-mails for Reducing Cancer-related Fatigue - a Study Protocol of a Randomized Controlled Trial

Acronym: Carfi

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 16, 2020
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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