Clinical trial · Interventional
Effect of Oxygen Inhalation on Fatigue After Chemotherapy of Breast Cancer in High Altitude Area
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
At present, there are few studies on the side effects of chemotherapy in breast cancer patients at high altitude area, and there are no studies on the relationship between oxygen inhalation and fatigue after chemotherapy in breast cancer patients at high altitude. The investigators intend to explore whether oxygen inhalation can improve fatigue at high altitude through this prospective randomized study. In our study, a single center, open-label, randomized phase 2 clinical trial will conduct to investigate whether oxygen inhalation during chemotherapy can improve chemotherapy-related fatigue in patients with breast cancer. The effects of oxygen inhalation on side effects of chemotherapy such as Cancer related fatigue (CRF) were observed. The investigators intend to explore whether oxygen therapy can improve fatigue at high altitude through this prospective randomized study. The investigators enrolled breast cancer patients before chemotherapy. The investigators will use the checklist individual strength(CIS) and the brief fatigue inventory (BFI) to evaluate the fatigue status of patients, and extract the blood of patients for evaluate blood pro-inflammatory cytokines IL-1 β, IL-6, C-reactive protein (CRP), transforming growth factor (TGF-β), soluble tumor necrosis factor (TNF) receptor II (sTNF-RII), inducible factor-1(HIF-1), Hypoxia inducible factor-2(HIF-2)in the plasma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control group | Other | — | UNRESOLVED |
| Oxygen inhalation treatment group | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Oxygen inhalation treatment group
- description
- 1. Patients receive chemotherapy for breast cancer. 2. Patients are randomly divided into inhalation treatment group. Oxygen inhalation is started on the first day of chemotherapy, and the oxygen inhalation volume is 2 L / min, 8 hours / day for 3 consecutive days.(d1,d2,d3). 3. Blood samples are collected before and after chemotherapy(d0,d3). 4. CIS and BFI are measured before chemotherapy(d0, d3 chemotherapy regimen/ d0, d3, chemotherapy regimen).
- interventionNames
- Other: Oxygen inhalation treatment group
- type
- PLACEBO_COMPARATOR
- label
- Oxygen non-inhalation treatment group
- description
- 1. Patients receive chemotherapy for breast cancer. 2. Patients are randomly divided into non-inhalation treatment group. 3. Blood samples are collected before and after chemotherapy(d0,d3). 4. CIS and BFI are measured before chemotherapy(d0, d3,chemotherapy regimen/ d0, d3, chemotherapy regimen).
- interventionNames
- Other: Control group
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female breast cancer patients aged ≥ 18 years old; 2. Breast cancer was confirmed by histopathological investigation; 3. Chemotherapy including neoadjuvant chemotherapy, postoperative adjuvant chemotherapy and palliative chemotherapy for advanced breast cancer; 4. Eastern Cooperative Oncology Group(ECOG )score of physical condition (0-1); 5. Voluntarily participate in the clinical trial and sign the informed consent form after informed consent (patients voluntarily accept the test and give informed consent); 6. The basic indexes were consistent, and the blood routine and ECG were normal; 7. Before chemotherapy, fatigue scale was used to score, and no fatigue symptom was confirmed by CIS and BFI; Exclusion Criteria: 1. Due to nervous system disease, difficulty in understanding and / or lack of personnel unable to complete the report; 2. The patients were treated with radiotherapy at the same time of chemotherapy; 3.There were no other tumors, and brain metastases and pleural effusion were excluded; 4.Women diagnosed with untreated anemia and thyroid dysfunction; 5.Heart and lung diseases were excluded; 6.The respiratory system diseases affecting blood oxygen saturation were excluded; 7.Fatigue symptoms were confirmed by cis and BFI.
References
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