Clinical trial NCT04193722: The Effect of Hyperbaric OxygeN Therapy on brEast Cancer Patients With Late Radiation toxicitY - UMBRELLA HONEY Trial
Official title: The Effect of Hyperbaric Oxygen Therapy on Breast Cancer Patients With Late Radiation Toxicity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Radiation Toxicity
Keywords: Breast cancer
Radiotherapy
Hyperbaric oxygen therapy
Late toxicity
Trials within cohorts
Patient reported outcomes
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 189
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Trial within cohorts design
Primary purpose: TREATMENT

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.

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.

Eligibility 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).

Primary outcomes:
measure: Change in breast/chest wall pain: EORTC QLQ-BR23 questionnaire
timeFrame: Baseline and 6 months after baseline (i.e. 3 months after HBOT)
Secondary outcomes:
measure: Change in patient-reported quality of life: (EORTC QLQ) C30
timeFrame: Baseline and 6 months after baseline (i.e. 3 months after HBOT)
measure: Change in patient-reported late radiation toxicity
timeFrame: Baseline and 6 months after baseline (i.e. 3 months after HBOT)
measure: Physician-reported late radiation toxicity
timeFrame: 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)
measure: Patient-reported cosmetic outcome
timeFrame: Baseline and 6 months after baseline (i.e. 3 months after HBOT)
measure: Physician-reported cosmetic outcome
timeFrame: Baseline and 6 months after baseline (i.e. 3 months after HBOT)
measure: Number of participants with side effects of treatment with hyperbaric oxygen therapy
timeFrame: During hyperbaric oxygen treatment sessions and at 3 months after last HBO session
measure: Oxygenation of the skin
timeFrame: Baseline and prior to last hyperbaric oxygen session (i.e. 3 months after baseline).
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: Imaging Division, UMC Utrecht
name: Helena M Verkooijen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Batenburg MCT, van den Bongard HJGD, Kleynen CE, Maarse W, Witkamp A, Ernst M, Doeksen A, van Dalen T, Sier M, Schoenmaeckers EJP, Baas IO, Verkooijen HM. Assessing the effect of hyperbaric oxygen therapy in breast cancer patients with late radiation toxicity (HONEY trial): a trial protocol using a trial within a cohort design. Trials. 2020 Nov 27;21(1):980. doi: 10.1186/s13063-020-04869-z.