Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04774497 |
| Other study ID # |
AHQU-2021001 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2021 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
October 2021 |
| Source |
Affiliated Hospital of Qinghai University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
