Breast CancerNCT04774497
Effect of Oxygen Inhalation on Fatigue After Chemotherapy of Breast Cancer in High Altitude Area
A study testing Oxygen inhalation treatment group in people with Breast Cancer, run by Jiuda Zhao at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Oxygen inhalation treatment group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female breast cancer patients aged ≥ 18 years old;
- Breast cancer was confirmed by histopathological investigation;
- Chemotherapy including neoadjuvant chemotherapy, postoperative adjuvant chemotherapy and palliative chemotherapy for advanced breast cancer;
- Eastern Cooperative Oncology Group(ECOG )score of physical condition (0-1);
- Voluntarily participate in the clinical trial and sign the informed consent form after informed consent (patients voluntarily accept the test and give informed consent);
- The basic indexes were consistent, and the blood routine and ECG were normal;
- Before chemotherapy, fatigue scale was used to score, and no fatigue symptom was confirmed by CIS and BFI;
Who cannot join
- Due to nervous system disease, difficulty in understanding and / or lack of personnel unable to complete the report;
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qinghai University Affiliated Hospital
Xining, Qinghai, 810000
Jiuda Zhao, MD, 13327661976, jiudazhao@126.com
About this study
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.
Read the detailed description
Fatigue is the most common symptom experienced by patients from cancer diagnosis to the end of life. CRF is different from other types of fatigue. It is severe, persistent and can not be alleviated by rest or sleep. CRF affects nearly 65% of cancer patients, more than two-thirds believe that severe CRF lasts at least 6 months, and one-third report that fatigue persists for several years after chemotherapy.
The etiology of CRF has not been fully elucidated, although it may involve several physiological and biochemical systems, which may vary with tumor type, disease stage and treatment. Recently, several cytokines and other proinflammatory mediators produced in tryptophan degradation and cancer response are associated with fatigue; however, their direct role in the pathogenesis of fatigue remains controversial. Cytokines may play a role at a variety of levels, including mood, muscle mass, strength and metabolic status, and thus are associated with the pathophysiology of fatigue. Recent studies have shown that fatigue is positively correlated with circulating levels of inflammatory markers, especially IL-6, IL-1 and neopterin, which are significantly correlated with CRF. CRF is also common in breast cancer patients, and the incidence rate of CRF is increasing as the incidence of breast cancer increases. In the treatment of breast cancer patients, chemotherapy can cause some patients' non hematological side effects such as fatigue. During the chemotherapy of breast cancer at high altitude area, clinical observation showed that the incidence rate of side effects after chemotherapy was higher in plateau area. Retrospectively analyzed the efficacy and safety of epirubicin combined with taxanes chemotherapy in the treatment of 48 cases of breast cancer in high altitude areas of Tibet. It was found that 89.5% of the patients with neutropenia after chemotherapy were significantly higher than those in low altitude areas, which also confirmed this phenomenon. The increased side effects of chemotherapy and radiotherapy in cancer patients at high altitude are closely related to hypoxia. The oxygen content and oxygen partial pressure in the atmosphere of plateau area also decrease with the increase of altitude, and the oxygen partial pressure in human alveoli also decreases, so the arterial oxygen partial pressure and saturation also decrease. A number of studies have shown that the special hypoxia environment at high altitude will have a lot of effects on the human body. In terms of cardiovascular system, it will make pulmonary hypertension and heart rate increase, and make the heart bear a heavy pressure load, leading to the occurrence of high altitude heart disease. In terms of nervous system, chronic hypoxia environment is prone to sleep disordered breathing at night, which seriously affects the brain nerve function and leads to heart failure sleep structure disorder. On the other hand, in order to adapt to the outside world, the human body in the plateau environment, within a certain limit, through the regulation of the nervous system and body fluid mechanism, carries out a series of adjustments and stress reactions, It makes a series of physiological changes in body fluid, hemorheology, blood biochemistry, blood gas and organ function, and some pathological changes, resulting in changes in physiological indexes, drug plasma protein binding rate, drug metabolic enzyme activity and expression, and inflammatory factors in blood. The investigators speculate that the above factors lead to the increase of side effects after chemotherapy at high altitude, especially the influence of inflammatory cytokines in the blood, leading to the occurrence of CRF.
- Conditions
- Breast Cancer
- Being tested
- Oxygen inhalation treatment group, Control group
- Keywords
- Breast Cancer, Chemotherapy, Fatigue, Oxygen, High altitude
- Medical subject headings
- Breast Neoplasms, Fatigue, Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen inhalation treatment groupOther
Oxygen inhalation group: oxygen inhalation was started on the first day of chemotherapy, and the oxygen inhalation volume was 2 L / min, 8 hours / day for 3 consecutive days.
Control groupOther
The control group was not given oxygen inhalation.
| Study group | Role | What they receive |
|---|---|---|
| Oxygen inhalation treatment group | Experimental | 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). Receives: Other: Oxygen inhalation treatment group |
| Oxygen non-inhalation treatment group | Placebo comparator | 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). Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue was measured by Checklist for Individual Strength(CIS).
We use the Checklist for Individual Strength(CIS)fatigue scale to compare the fatigue degree of the experimental group and the control group before and after chemotherapy. In our study, we selected 8 questions in the CIS scale, each patient should answer these 8 questions, and then record the score according to the patients' answers. Each question can be scored according to absolute right and absolute wrong, and the score is from 8 to 56.
Measured: The difference of fatigue degree between the two groups on baseline and third day after chemotherapy
Secondary outcomes (5)
Fatigue was measured by Brief Fatigue Inventory (BFI) .
We used the Brief Fatigue Inventory (BFI) to compare the fatigue degree of the experimental group and the control group before and after chemotherapy. There are four questions in the BFI. The fourth question contains six small questions. The score of the questionnaire ranges from 0 to 90.
Measured: The difference of fatigue degree between the two groups on baseline and third day after chemotherapy
Blood pressure
Blood pressure refers to the lateral pressure of blood flow in blood vessels, including systolic pressure and diastolic pressure. We use mmHg to measure blood pressure.
Measured: The day before chemotherapy and the third day after chemotherapy.
Biomarker in blood
pro-inflammatory cytokines IL-1 β, IL-6, C-reactive protein (CRP) , soluble tumor necrosis factor (TNF) receptor II (sTNF-RII),transforming growth factor (TGF-β) , Hypoxia inducible factor-1(HIF-1) , Hypoxia inducible factor-2(HIF-2)
Measured: The difference Biomarker level between the two groups on baseline and third day after chemotherapy
Oxygen saturation
It is the percentage of oxygenated hemoglobin volume in the blood, that is, the oxygen concentration in the blood, which is called arterial oxygen saturation. It is usually measured by the percentage sign (%).
Measured: The day before chemotherapy and the third day after chemotherapy.
Heart rate
Heart rate refers to the number of heart beats per minute in a normal person's quiet state, also known as the quiet heart rate, which is generally 60-100 beats per minute. We use beats per minute to measure it.
Measured: The day before chemotherapy and the third day after chemotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Mar 2021
- Primary completion1 Nov 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiuda Zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jiuda Zhao, Affiliated Hospital of Qinghai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774497
- Sponsor's protocol ID
- AHQU-2021001
- Status last verified
- Oct 2021
- First submitted
- 18 Feb 2021
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oxygen Inhalation on Fatigue After Chemotherapy of Breast Cancer in High Altitude Area
- ClinicalTrials.gov ID
- NCT04774497
- Acronym / sponsor ID
- AHQU-2021001
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Chemotherapy, Fatigue, Oxygen, High altitude
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Jiuda ZhaoUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Fatigue is the most common symptom experienced by patients from cancer diagnosis to the end of life. CRF is different from other types of fatigue. It is severe, persistent and can not be alleviated by rest or sleep. CRF affects nearly 65% of cancer patients, more than two-thirds believe that severe CRF lasts at least 6 months, and one-third report that fatigue persists for several years after chemotherapy.
The etiology of CRF has not been fully elucidated, although it may involve several physiological and biochemical systems, which may vary with tumor type, disease stage and treatment. Recently, several cytokines and other proinflammatory mediators produced in tryptophan degradation and cancer response are associated with fatigue; however, their direct role in the pathogenesis of fatigue remains controversial. Cytokines may play a role at a variety of levels, including mood, muscle mass, strength and metabolic status, and thus are associated with the pathophysiology of fatigue. Recent studies have shown that fatigue is positively correlated with circulating levels of inflammatory markers, especially IL-6, IL-1 and neopterin, which are significantly correlated with CRF. CRF is also common in breast cancer patients, and the incidence rate of CRF is increasing as the incidence of breast cancer increases. In the treatment of breast cancer patients, chemotherapy can cause some patients' non hematological side effects such as fatigue. During the chemotherapy of breast cancer at high altitude area, clinical observation showed that the incidence rate of side effects after chemotherapy was higher in plateau area. Retrospectively analyzed the efficacy and safety of epirubicin combined with taxanes chemotherapy in the treatment of 48 cases of breast cancer in high altitude areas of Tibet. It was found that 89.5% of the patients with neutropenia after chemotherapy were significantly higher than those in low altitude areas, which also confirmed this phenomenon. The increased side effects of chemotherapy and radiotherapy in cancer patients at high altitude are closely related to hypoxia. The oxygen content and oxygen partial pressure in the atmosphere of plateau area also decrease with the increase of altitude, and the oxygen partial pressure in human alveoli also decreases, so the arterial oxygen partial pressure and saturation also decrease. A number of studies have shown that the special hypoxia environment at high altitude will have a lot of effects on the human body. In terms of cardiovascular system, it will make pulmonary hypertension and heart rate increase, and make the heart bear a heavy pressure load, leading to the occurrence of high altitude heart disease. In terms of nervous system, chronic hypoxia environment is prone to sleep disordered breathing at night, which seriously affects the brain nerve function and leads to heart failure sleep structure disorder. On the other hand, in order to adapt to the outside world, the human body in the plateau environment, within a certain limit, through the regulation of the nervous system and body fluid mechanism, carries out a series of adjustments and stress reactions, It makes a series of physiological changes in body fluid, hemorheology, blood biochemistry, blood gas and organ function, and some pathological changes, resulting in changes in physiological indexes, drug plasma protein binding rate, drug metabolic enzyme activity and expression, and inflammatory factors in blood. The investigators speculate that the above factors lead to the increase of side effects after chemotherapy at high altitude, especially the influence of inflammatory cytokines in the blood, leading to the occurrence of CRF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxygen inhalation treatment group | Experimental | Other: Oxygen inhalation treatment group1. 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). |
| Oxygen non-inhalation treatment group | Placebo comparator | Other: Control group1. 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female breast cancer patients aged ≥ 18 years old;
- Breast cancer was confirmed by histopathological investigation;
- Chemotherapy including neoadjuvant chemotherapy, postoperative adjuvant chemotherapy and palliative chemotherapy for advanced breast cancer;
- Eastern Cooperative Oncology Group(ECOG )score of physical condition (0-1);
- Voluntarily participate in the clinical trial and sign the informed consent form after informed consent (patients voluntarily accept the test and give informed consent);
Key exclusion criteria (3 listed)
- Due to nervous system disease, difficulty in understanding and / or lack of personnel unable to complete the report;
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygen inhalation treatment groupOxygen inhalation group: oxygen inhalation was started on the first day of chemotherapy, and the oxygen inhalation volume was 2 L / min, 8 hours / day for 3 consecutive days. | Other | Oxygen inhalation treatment group |
| Control groupThe control group was not given oxygen inhalation. | Other | Oxygen non-inhalation treatment group |
Primary outcome
Fatigue was measured by Checklist for Individual Strength(CIS).
Time frame: The difference of fatigue degree between the two groups on baseline and third day after chemotherapy
We use the Checklist for Individual Strength(CIS)fatigue scale to compare the fatigue degree of the experimental group and the control group before and after chemotherapy. In our study, we selected 8 questions in the CIS scale, each patient should answer these 8 questions, and then record the score according to the patients' answers. Each question can be scored according to absolute right and absolute wrong, and the score is from 8 to 56.
5 secondary outcomes
Fatigue was measured by Brief Fatigue Inventory (BFI) .
Time frame: The difference of fatigue degree between the two groups on baseline and third day after chemotherapy
Blood pressure
Time frame: The day before chemotherapy and the third day after chemotherapy.
Biomarker in blood
Time frame: The difference Biomarker level between the two groups on baseline and third day after chemotherapy
Oxygen saturation
Time frame: The day before chemotherapy and the third day after chemotherapy.
Heart rate
Time frame: The day before chemotherapy and the third day after chemotherapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen inhalation treatment group in people with Breast Cancer, run by Jiuda Zhao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue was measured by Checklist for Individual Strength(CIS). (time frame: The difference of fatigue degree between the two groups on baseline and third day after chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.