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

NCT04193722 | Completed Phase 3 DMC

• 1 other identifier: NL69081.041.19
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Radiation Toxicity

Keywords

Breast cancer; Radiotherapy; Hyperbaric oxygen therapy; Late toxicity; Trials within cohorts; Patient reported outcomes

Outcome Measures

Primary Outcomes (1)

• Change in breast/chest wall pain: EORTC QLQ-BR23 questionnaire

  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.

  Baseline and 6 months after baseline (i.e. 3 months after HBOT)

Secondary Outcomes (7)

• Change in patient-reported quality of life: (EORTC QLQ) C30

  Baseline and 6 months after baseline (i.e. 3 months after HBOT)

• Change in patient-reported late radiation toxicity

  Baseline and 6 months after baseline (i.e. 3 months after HBOT)

• Physician-reported late radiation toxicity

  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)

• Patient-reported cosmetic outcome

  Baseline and 6 months after baseline (i.e. 3 months after HBOT)

• Physician-reported cosmetic outcome

  Baseline and 6 months after baseline (i.e. 3 months after HBOT)

Study Arms (2)

Hyperbaric oxygen therapy

EXPERIMENTAL

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

Usual care

NO INTERVENTION

Usual care may consist of physiotherapy, analgetics, edema therapy

Interventions

Hyperbaric oxygen therapy DRUG

Hyperbaric oxygen therapy in a multiperson hyperbaric oxygen chamber. Standard hyperbaric oxygen therapy provided as reimbursed by insurers.

Also known as: Oxygen

Hyperbaric oxygen therapy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

University Medical Center Utrecht

Utrecht, Utrecht, 3508GA, Netherlands

Location

Related Publications (2)

• Mink van der Molen DR, Batenburg MCT, Maarse W, van den Bongard DHJG, Doeksen A, de Lange MY, van der Pol CC, Evers DJ, Lansdorp CA, van der Laan J, van de Ven PM, van der Leij F, Verkooijen HM. Hyperbaric Oxygen Therapy and Late Local Toxic Effects in Patients With Irradiated Breast Cancer: A Randomized Clinical Trial. JAMA Oncol. 2024 Apr 1;10(4):464-474. doi: 10.1001/jamaoncol.2023.6776.

  PMID: 38329746 DERIVED

• 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.

  PMID: 33246494 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Radiation Injuries

Interventions

Hyperbaric Oxygenation; Oxygen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics; Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Helena M Verkooijen, MD, PhD

  Imaging Division, UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Model Details: Trial within cohorts design

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: December 10, 2019
• Study Start: August 28, 2019
• Primary Completion: May 8, 2023
• Study Completion: May 8, 2023
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

NL (1)