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VITALITY Study: Use of Intermittent Hypoxia-Hyperoxia Training (IHHT) for the Reduction of Fatigue in Cancer Survivors – a randomised controlled trial

VITALITY Study: Use of Intermittent Hypoxia-Hyperoxia Training (IHHT) for the Reduction of Fatigue in Cancer Survivors – a randomised controlled trial - VITALITY

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00039606
Enrollment
90
Registered
2026-04-13
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer survivor experiencing fatigue

Interventions

Group 1: Intermittent Hypoxia-Hyperoxia Training (IHHT) The intervention consists of two sessions per week, each lasting 45 minutes. Each session comprises 6–8 cycles of alternating oxygen concentrati

Sponsors

Universitätsklinikum Hamburg - Eppendorf
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Cancer survivors defined as (hemato-)oncological patients in follow-up care = 6 months after completion of tumor-directed therapy* with no evidence of disease recurrence. (*Ongoing antihormonal therapy (aromatase inhibitors, tamoxifen) or CDK4/6 inhibitors are not excluded.) - Fatigue score = 4 on a numerical rating scale (NRS, 0–10). - Age = 18 years. - Access to the internet as well as a PC, laptop, or tablet. - Proficiency in the German language (written and spoken). - Willingness to participate in an IHHT study / signed informed consent. - ECOG Performance Status 0–2.

Exclusion criteria

Exclusion criteria: - History of hypoxia intolerance. - Resting hypoxemia (SpO2 <90%). - Anemia = CTCAE Grade 1 (<10 g/dL) or blood transfusion within the last four weeks. - Sickle cell anemia. - Inadequately controlled diabetes mellitus. - Known, unstable thyroid disease, particularly hypothyroidism. - Instable coronary heart disease. - Uncontrolled cardiac arrhythmia. - Uncontrolled arterial hypertension. - Recent myocardial infarction or stroke (<3 months). - Aortocoronary bypass surgery (CABG) (<3 months). - Epilepsy or other seizure disorders. - Severe migraine with aura. - Increased intracranial pressure. - Advanced non-oncological chronic diseases: Child-Pugh Class C liver cirrhosis, end-stage renal disease, heart failure (NYHA III or IV). - Pregnancy. - Previous participation in similar interventions or established active IHHT practice. - Cognitive or linguistic barriers impairing the performance of the interventions. - Other diseases or conditions that, in the investigator’s opinion, jeopardize patient safety or the feasibility of the study.

Design outcomes

Primary

MeasureTime frame
Change in Brief Fatigue Inventory (BFI) score from baseline (T0) to post-intervention (T1)

Secondary

MeasureTime frame
- MFI-20 - EORTC QLQ-C30 - PHQ-9 - GAD-7 - PSQI - FitMáx© questionnaire - Functional status / clinical functional tests -- Heart rate variability (HRV) measured by TUR CellOxy® -- 6-minute walk test (6MWT) -- Handgrip strength measured by dynamometer - Qualitative evaluation

Countries

Germany

Contacts

Public ContactAlina Busch

Universitätsklinikum Hamburg - Eppendorf

al.busch@uke.de004074100

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 29, 2026