Trial document




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  DRKS00011689

Trial Description

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Title

Feasibility of high-intensity interval training with hyperoxia in cancer patients undergoing chemotherapy

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Trial Acronym

Hyperoxie Studie

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URL of the Trial

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Brief Summary in Lay Language

In previous studies it was shown that additional oxygen supply during intense physical exercise reduces the perceived exertion of patients and, thus, increases compliance. The aim of the present study is, thus, to investigate the compliance and feasibility of high intensity aerobic training with modified oxygen concentrations in gastrointestinal tumor patients undergoing chemotherapy. Since it was also shown that changed oxygen concentrations may induce a chain of physiological reactions, possibly blunting tumor growth and reduce the possibility of a relapse, this study also aims at providing a detailed biochemical profile of these patients before and after the training.

NB: The title of this study was amended on May 31, 2017, due to a change in the inclusion criteria.

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Brief Summary in Scientific Language

Adherence to regular exercise in patients suffering from aggressive cancer entities, such as gastrointestinal tumors is typically poor. This is especially related to the high toxicity of treatments such as chemotherapy, which typically lead to a large degree of fatigue. Thus, studies investigating the effects of regular exercise on the effects of tumor progression and overall wellbeing in cancer patients should consider methods which are perceived less demanding, while still providing sufficient physiological stimuli. In previous studies of our Department we were able to show that in diabetic paients the perceived exertion is considerably reduced when the inhaled oxygen concentration was increased (i.e. hyperoxia). Since the available oxygen also directly affects biochemical signalling pathways linked to immune function and tumor growth as well as the expression of relapsed carcinoma, modifying inhaled oxygen concentrations may be an interesting concept for the exercise therapy of cancer patients as well.
This study, thus, aims to investigate the physiological effects of intensive aerobic exercise training in hyperoxia in gastrointestinal cancer patients during chemotherapy. Patients will be randomize in either of the 2 intervention groups (hyperoxia or normoxia) or the controll group, performing high-intensity interval training (HIIT) on a bike ergometer for 4 weeks. Patients in the control group will attend the measurements but will not perform any training.
The primary outcome of this study is to assess the feasibility of these training regimens and the adherence of the patients as well to investigate the effects of the training on the immune status of the participants.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00011689
  •   2017/02/27
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  •   yes
  •   Approved
  •   004/2017, Deutsche Sporthochschule Köln Am Sportpark Müngersdorf 6 50633 Köln Deutschland https://www.dshs-koeln.de/
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Secondary IDs

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Health Condition or Problem studied

  •   all carcinoma (except for lung carcinoma)
  •   C00-C97 -  Malignant neoplasms
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Interventions/Observational Groups

  •   2 times weekly high intensity interval training in normoxic conditions (no modified oxygen concentrations) for 4 weeks
  •   2 times weekly high intensity interval training in hyperoxic conditions (increased oxygen concentrations) for 4 weeks
  •   Control group (no training)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group), Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Feasibility and compliance assessed by the following questionnaires (at baseline and after 4 weeks of training):

BPI-SF (Brief Pain Inventory - Short Form)
FACIT-F (Functional Assessment of Chronic Illness Therapy - Fatigue)
FACIT-TS-G (Functional Assessment of Chronic Illness Therapy - Treatment rating)
PSQI (Pittsburgh Sleep Quality Index)

Immune status assessed by venous blood analyses (at baseline and after 4 weeks of training).

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Secondary Outcome

Cognitive function assessed by questionnaire FACT-Cog (Functional Assessment of Cancer Therapy - Cognitive Function) (Baseline and after 4 weeks of training)

Quality of life assessed by questionnaire EORTC-QLQ-C30 (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire) (Baseline und nach 4 Wochen Training)

Health perception assessed by questionnaire EQ-5D (EuroQol five dimensions questionnaire) (Baseline and after 4 weeks of training)

Aerobic capacity assessed by incremental cycle ergometer test (Baseline and after 4 weeks of training)

Maximal strength of leg exensors assessed by a dynamic one repetition maximum test (Baseline and after 4 weeks of training)

Physiological and psychological stress assessed by heart rate variability (3 x wöchentlich)

Arterial stiffnes assessed by pulse wave analysis (Baseline and after 4 weeks of training)

Additional biochemical analyses by venous blood samples (Baseline and after 4 weeks of training)

Acute loading measurements:

In addition, acute responses to a single training session will also be assessed throughout and after the first (week 1) and last (week 4) training session. These include:

Assessment of Blood lactate concentrations
Assessment of Fatigue (FACIT-F)
Assessment of Rate of perceived Exertion (RPE Scale)
Assessment of heart rate
Assessment of heart rate variability
Oxygen saturation

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2017/07/25
  •   48
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

Men with carcinoma undergoing chemotherapy as an adjuvant or primary therapy

Patients treated with conventional chemotherapy:
- Alkylating agents
- Antimetabolites
- Anthracyclines
- Taxanes
- Vincaalcaloides
- Patients treated with antibody therapy

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Exclusion Criteria

- Patients with lung-ca
- Relapsed carcinoma
- Recent serious cardiovascular events (including but not limited to poorly controlled hypertension and congestive heart failure)
- Medical condition such as uncontrolled infection or cardiac disease that, in the opinion of the physician, would make this protocol unreasonably hazardous for the patient
- Psychiatric illness, which would prevent the patient from giving informed consent or adhering to the study protocol
- Known spinal cord compromise or instrumentation due to metastatic disease. Radiation therapy for metastatic disease is allowed
- Peripheral neuropathy
- Men participating in vigorous aerobic exercise for more than 60 minutes per week or resistance exercise two or more days per week
- shortness of breath, chest discomfort, or palpitations when performing activities of daily living
- Men having difficulties of climbing a flight of stairs due to physical impairment
- Ongoing restriction of physical activity with physician documentation
- chest pain brought on by physical activity and chest pain developed in the past month
- Patients with carcinoma which limit physical exercise on a bike ergometer

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Addresses

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    • Deutsche Sporthochschule Köln, Institut für Kreislaufforschung und Sportmedizin, Abt.2: Molekulare und Zelluläre Sportmedizin
    • Mr.  Prof.  Wilhelm  Bloch 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    •   [---]*
    •   0221 4982 8370
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    • Deutsche Sporthochschule Köln, Institut für Kreislaufforschung und Sportmedizin, Abt. 2: Molekulare und Zelluläre Sportmedizin
    • Mr.  Dr.  Moritz  Schumann 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    • Deutsche Sporthochschule Köln, Institut für Kreislaufforschung und Sportmedizin, Abt. 2: Molekulare und Zelluläre Sportmedizin
    • Mr.  Dr.  Moritz  Schumann 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Sporthochschule Köln, Institut für Kreislaufforschung und Sportmedizin, Abt. 2: Molekulare und Zelluläre Sportmedizin
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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