Effect of Oxygen Inhalation on Fatigue After Chemotherapy of Breast Cancer in High Altitude Area

NCT04774497 | Unknown

• 1 other identifier: AHQU-2021001
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Chemotherapy; Fatigue; Oxygen; High altitude

Outcome Measures

Primary Outcomes (1)

• 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.

  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) .

  The difference of fatigue degree between the two groups on baseline and third day after chemotherapy

• Blood pressure

  The day before chemotherapy and the third day after chemotherapy.

• Biomarker in blood

  The difference Biomarker level between the two groups on baseline and third day after chemotherapy

• Oxygen saturation

  The day before chemotherapy and the third day after chemotherapy.

• Heart rate

  The day before chemotherapy and the third day after chemotherapy.

Study Arms (2)

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）.

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）.

Other: Control group

Interventions

Oxygen inhalation treatment group OTHER

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.

Oxygen inhalation treatment group

Control group OTHER

The control group was not given oxygen inhalation.

Oxygen non-inhalation treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Jiuda Zhao: lead

Study Sites (1)

Qinghai University Affiliated Hospital

Xining, Qinghai, 810000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Fatigue; Altitude Sickness

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: March 1, 2021
• Study Start: March 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: December 31, 2022
• Last Updated: October 29, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)