Steroid tablets for preventing tiredness in cancer patients receiving chemotherapy medicine.

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site Health Condition 2: C348- Malignant neoplasm of overlappingsites of bronchus and lung

Radhakrishnan V, Gopalakrishnan V, Vihari GV, Dasapathi VSKK, Perumal Kalaiyarasi J, Veeraiah S, Rajaraman S.

2025-07-31

10.1007/s00520-025-09807-w

Phase 3 randomized controlled trial comparing the effectiveness of dexamethasone in reducing cancer-associated fatigue in patients on palliative chemotherapy.

Venkatraman Radhakrishnan, Vamsi Vihari, Vidhya Gopalakrishnan, Venkata Siva Kiran Kumar Dasapathi, Jayachandran Perumal Kalaiyarasi et al. (7 authors)

JCO Global Oncology2023-08-01

10.1200/go.2023.9.supplement_1.134

Phase 3 RCT of dexamethasone versus placebo for chemotherapy induced fatigue in patients with advanced solid malignancies.

Venkatraman Radhakrishnan, Vidhya Gopalakrishnan, Vamsi Vihari, Venkata Siva Kiran Kumar Dasapathi, Rajaraman Swaminathan et al. (10 authors)

Journal of Clinical Oncology2023-06-01

10.1200/jco.2023.41.16_suppl.12112

Interventions

Intervention1: Dexamethasone: Dexamethasone tablets will be given at a dose of 4 mg daily for 12 weeks and then tapered over 1 week. The first dose of dexamethasone will start on the day of first dose

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients above 18 years and less than 60 years of age 2. Diagnosed with advanced breast or lung cancer and planned for palliative intravenous chemotherapy. 3. Not received chemotherapy in the preceding one month. 4. ECOG performance score of less than or equal to 2. 5. Normal cognition. 6. No contraindications to steroids. 7. Absence of active infection 8. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. History of diabetes mellitus or hypertension. 2. Past history of peptic ulcer or gastrointestinal bleed. 3. Congestive heart failure and ischemic heart disease. 4. Diseases like brain tumors and prostate cancer were corticosteroids are part of the treatment. Use of corticosteroids as anti-emetic is permitted. 5. Patient is mentally incapacitated or has a significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry. 6.Renal failure, hepatic failure, glaucoma, epilepsy. 7. HIV, HBV or HCV positive

Design outcomes

Primary

Measure	Time frame
To compare the magnitude and extent of fatigue as measured by Symbolic Assessment of Fatigue Extent (SAFE) scale between the dexamethasone group and standard group.Timepoint: Symbolic Assessment of Fatigue Extent (SAFE) scale will be used to calculate magnitude and extent of fatigue. The SAFE scale will be administered before the initiation of chemotherapy and at the end of 6 and 12 weeks of chemotherapy. The SAFE scale will be administered by the investigators or staff from the psycho-oncology department. NCI CTCAE V4.0 grading of fatigue will also be done.	—

Measure

Time frame

To compare the magnitude and extent of fatigue as measured by Symbolic Assessment of Fatigue Extent (SAFE) scale between the dexamethasone group and standard group.Timepoint: Symbolic Assessment of Fatigue Extent (SAFE) scale will be used to calculate magnitude and extent of fatigue. The SAFE scale will be administered before the initiation of chemotherapy and at the end of 6 and 12 weeks of chemotherapy. The SAFE scale will be administered by the investigators or staff from the psycho-oncology department. NCI CTCAE V4.0 grading of fatigue will also be done.

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Secondary

Measure	Time frame
To assess the difference in the incidence of adverse events between the dexamethasone group and standard group.Timepoint: Continuous daily assessment for 13 weeks since enrollment in study	—

Countries

India

Contacts

Public ContactVenkatraman Radhakrishnan

Cancer Institute, Chennai, India

venkymd@gmail.com9498082771

Outcome results

None listed