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The Effect of Hyperbaric OxygeN Therapy on brEast Cancer Patients With Late Radiation toxicitY - UMBRELLA HONEY Trial (HONEY)

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ClinicalTrials.gov Identifier: NCT04193722
Recruitment Status : Recruiting
First Posted : December 10, 2019
Last Update Posted : December 10, 2019
Sponsor:
Collaborator:
The Netherlands Cancer Institute
Information provided by (Responsible Party):
Helena M Verkooijen, UMC Utrecht

Brief Summary:
The "Hyperbaric OxygeN therapy on brEast cancer patients with late radiation toxicity" (HONEY) trial aims to evaluate the effectiveness of HBOT on late radiation toxicity in breast cancer patients using the trial within cohorts (TwiCs) design.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation Toxicity Drug: Hyperbaric oxygen therapy Phase 3

Detailed Description:

Objective: The aim of this study is to assess whether HBOT reduces pain, and improves physical functioning and QoL in breast cancer patients with late radiation toxicity.

Study design: Randomized controlled trial, nested within the prospective UMBRELLA breast cancer cohort according to the TWiC's design. UMBRELLA is a prospective cohort study including all breast cancer patients visiting the University Medical Center (UMC) Utrecht department of Radiotherapy. In total 120 patients will be randomized in a ratio of 2:1.

Study population: Breast cancer patients participating in the UMBRELLA cohort who have given informed consent to be invited for future research (e.g. cmRCT's), and who have reported symptoms of late radiation toxicity.

Intervention: Eligible patients will be referred to the HBO center for a standard HBO treatment. HBOT consists of 30-40 treatment sessions (1 session per day during 5 days per week). During the hyperbaric oxygen (HBO) sessions patients breath in 100% oxygen during 4 times 20 minutes in a hyperbaric chamber.

Main study parameters/endpoints: The primary endpoint of this study is patient reported breast/chest wall pain. Secondary endpoints are: physical functioning, QoL cosmetic outcome, physician reported pain and radiation toxicity (according to CTCAE criteria version 4.03, tissue oxygenation previous to HBOT and after HBOT and side-effects of HBOT.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Trial within cohorts design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Hyperbaric Oxygen Therapy on Breast Cancer Patients With Late Radiation Toxicity
Actual Study Start Date : August 28, 2019
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : September 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hyperbaric oxygen therapy
Hyperbaric oxygen therapy consists of 30-40 treatment sessions (1 session per day during 5 days per week). During the hyperbaric oxygen (HBO) sessions the pressure will be raised to 2.4 atmospheres absolute in a hyperbaric chamber and patients breath in 100% oxygen during 4 times 20 minutes.
Drug: Hyperbaric oxygen therapy
Hyperbaric oxygen therapy in a multiperson hyperbaric oxygen chamber. Standard hyperbaric oxygen therapy provided as reimbursed by insurers.
Other Name: Oxygen

No Intervention: Usual care
Usual care may consist of physiotherapy, analgetics, edema therapy



Primary Outcome Measures :
  1. Change in breast/chest wall pain: EORTC QLQ-BR23 questionnaire [ Time Frame: Baseline and 6 months after baseline (i.e. 3 months after HBOT) ]
    The primary endpoint of this study is the difference in proportion of patient-reported breast/chest wall pain grade 3-4 between control and intervention group. Pain is assessed by means of the EORTC QLQ-BR23 questionnaire on a 4-point Likert scale. At baseline all patients have a pain score of 3 or 4 (see inclusion criteria). The proportion of patients with 3-4 at 6 months will be compared between intervention and control group. A higher score indicates more pain.


Secondary Outcome Measures :
  1. Change in patient-reported quality of life: (EORTC QLQ) C30 [ Time Frame: Baseline and 6 months after baseline (i.e. 3 months after HBOT) ]
    Quality of life (QoL) measured by European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30. QoL will be scored on a scale of 0-100. A higher score indicates a better outcome. Change in score between baseline and 6 months will be compared between intervention and control group.

  2. Change in patient-reported late radiation toxicity [ Time Frame: Baseline and 6 months after baseline (i.e. 3 months after HBOT) ]
    Late radiation toxicity is assessed by means of a late radiation toxicity questionnaire (ability to move the arm, (breast) edema, fibrosis) in both control group and intervention group. Change in patient reported late radiation toxicity will be compared between intervention and control group. Late radiation toxicity will be assessed on a 4-point Likert scale. A higher score indicates worse outcomes.

  3. Physician-reported late radiation toxicity [ Time Frame: Baseline (prior to HBOT), 3 months after baseline (i.e. after HBOT) and 6 months after baseline (i.e. 3 months after the last HBO session) ]
    Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 only in intervention group. CTCAE criteria are assessed on a scale of 0-3.

  4. Patient-reported cosmetic outcome [ Time Frame: Baseline and 6 months after baseline (i.e. 3 months after HBOT) ]
    Assessed by means of the breast cancer questionnaire (BREAST-Q) in both control group and intervention group. BREAST-Q scores will be assessed using the BREAST-Q scoring tables.

  5. Physician-reported cosmetic outcome [ Time Frame: Baseline and 6 months after baseline (i.e. 3 months after HBOT) ]
    Reported by means of medical photograph (cosmetic outcome judged by group of experts and "Breast Cancer Conservative Treatment - cosmetic results" (BCCT.core) program) and with physical examination using the Patient and Observer Scar Assessment Scale (POSAS) score v2.0. Physician reported cosmetic outcome will only be assessed in the intervention group.

  6. Number of participants with side effects of treatment with hyperbaric oxygen therapy [ Time Frame: During hyperbaric oxygen treatment sessions and at 3 months after last HBO session ]
    Side effects of HBOT will be monitored using the MacFie classification only in the intervention group.

  7. Oxygenation of the skin [ Time Frame: Baseline and prior to last hyperbaric oxygen session (i.e. 3 months after baseline). ]
    Skin oxygenation will be measured prior to HBOT and after last treatment session using transcutaneous oxygen measurement. The contralateral breast will be used as a reference. Only assessed in the intervention group.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Self reported pain grade 3-4 (on a scale of 1-4) as assessed by the late radiation toxicity questionnaire;
  • Participation >12 months in the UMBRELLA cohort;
  • Previous treatment with radiotherapy for breast cancer;
  • Completed surgery and (neo)adjuvant systemic therapy except adjuvant endocrine therapy, for breast cancer.

Exclusion Criteria:

  • Poor responder to questionnaires (i.e. return of ≤ 2 UMBRELLA questionnaires);
  • Previous HBOT;
  • Contra-indications for HBOT (e.g. (severe) chronic obstructive pulmonary disease (COPD) or asthma, pacemaker, morbid obesity, epilepsy in medical history, severe heart failure);
  • Current metastatic disease or recurrent breast cancer.

Additional exclusions criteria based on screening visit:

  • Inability to follow schedule of all consecutive HBO treatments (e.g. due to scheduled holidays > 2 days);
  • Not meeting criteria for HBOT (e.g. due to complaints similar to late radiation toxicity, not caused by radiotherapy).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04193722


Contacts
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Contact: Helena M Verkooijen, MD, PhD +31 88 7559575 ext +31 h.m.verkooijen@umcutrecht.nl
Contact: Marilot CT Batenburg, MD +31 887567828 ext +31 m.c.t.batenburg-3@umcutrecht.nl

Locations
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Netherlands
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3508GA
Contact: Helena M Verkooijen, MD, PhD    088 7559575 ext +31    h.m.verkooijen@umcutrecht.nl   
Contact: Marilot CT Batenburg, MD       m.c.t.batenburg-3@umcutrecht.nl   
Sub-Investigator: Marilot CT Batenburg, MD         
Principal Investigator: Helena M Verkooijen, MD, PhD         
Sponsors and Collaborators
UMC Utrecht
The Netherlands Cancer Institute
Investigators
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Principal Investigator: Helena M Verkooijen, MD, PhD Imaging Division, UMC Utrecht

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Responsible Party: Helena M Verkooijen, Prof. dr., UMC Utrecht
ClinicalTrials.gov Identifier: NCT04193722    
Other Study ID Numbers: NL69081.041.19
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Helena M Verkooijen, UMC Utrecht:
Breast cancer
Radiotherapy
Hyperbaric oxygen therapy
Late toxicity
Trials within cohorts
Patient reported outcomes
Additional relevant MeSH terms:
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Breast Neoplasms
Radiation Injuries
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Wounds and Injuries