Yoga Intervention for Reducing Fatigue in Cancer Patients

NCT04433793 | Completed

• 1 other identifier: DRKS00016034
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fatigue; Cancer

Keywords

Yoga; Mindfulness based Intervention; Fatigue; Cancer Patients

Outcome Measures

Primary Outcomes (1)

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

  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

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

Secondary Outcomes (2)

• Changes from Quality of life in cancer patients

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

• Changes from Depression

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

Study Arms (2)

Yoga group

EXPERIMENTAL

Patients in the yoga group will receive yoga therapy, one hour every week for eight weeks.

Behavioral: Yoga therapy

Waitlist-control group

NO INTERVENTION

Patients in the waitlist-control group will receive no intervention at first, but nine weeks after IG, they will get the opportunity to also receive yoga therapy for 8 weeks.

Interventions

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).

Yoga group

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Wuerzburg University Hospital: lead
• German Cancer Aid: collaborator

Study Sites (1)

Universitätsklinikum Würzburg, Interdisciplinary Centre, Palliativ Medicine

Würzburg, Bavaria, 97080, Germany

Location

Related Publications (2)

• Zetzl T, Schuler M, Renner A, Jentschke E, van Oorschot B. Yoga intervention and reminder e-mails for reducing cancer-related fatigue - a study protocol of a randomized controlled trial. BMC Psychol. 2019 Sep 18;7(1):64. doi: 10.1186/s40359-019-0339-3.

  PMID: 31533823 BACKGROUND

• Messer S, Oeser A, Wagner C, Wender A, Cryns N, Scherer RW, Mishra SI, Monsef I, Holtkamp U, Andreas M, Brockelmann PJ, Ernst M, Skoetz N. Yoga for fatigue in people with cancer. Cochrane Database Syst Rev. 2025 May 27;5(5):CD015520. doi: 10.1002/14651858.CD015520.

  PMID: 40421669 DERIVED

MeSH Terms

Conditions

Fatigue; Neoplasms

Interventions

Yoga

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized controlled trial with cancer patients suffering from fatigue is planned. The study investigates the efficacy in terms of fatigue, depression and quality of life of eight-week yoga therapy (intervention group) compared to an 8-week waiting period without supportive intervention (control group).

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 16, 2020
• Study Start: October 12, 2018
• Primary Completion: March 16, 2020
• Study Completion: October 1, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: starting 6 months after publication for 1 year
• Access Criteria: for comparisons of efficacy of different yoga styles or supportive therapy in cancer patients

Locations

DE (1)