Breast CancerPhase 2/3NCT07865988
Efficacy of High-Dose Melatonin in Alleviating Radiotherapy-Induced Fatigue in Breast Cancer Patients
A Phase 2/3 study testing Melatonin in people with Breast Cancer and Radiotherapy Induced Fatigue, run by Menoufia University at 1 site in Egypt.
Trial summary
To assess the role of High-Dose Melatonin in Alleviating Radiotherapy-Induced Fatigue in Breast Cancer Patients. The primary end point is assessment of fatigue severity . Secondary end points Assessment of skin toxicity to evaluate melatonin's secondary radioprotective benefits Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Breast Cancer, Radiotherapy Induced Fatigue
- What is being tested?
- Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Oct 2024to 20 Aug 2026
- Phase
- Phase 2/3
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Female patients, aged 18-70 years, with histologically confirmed Breast Cancer (Stage II-III).
- Scheduled for adjuvant radiotherapy including a tumor bed boost and/or Regional Lymph Node Irradiation (LNI).
- Baseline Fatigue score > 4 on the Piper Fatigue Scale .
- ECOG Performance Status of 0-1
Who cannot join
- • History of autoimmune diseases or chronic inflammatory conditions.
- Current use of exogenous melatonin or systemic corticosteroids.
- Metastatic disease (Stage IV).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Menoufia University, Faculty of medicine
Shibīn al Kawm, Menoufia, 32511
About this study
Official title: Efficacy of High-Dose Melatonin in Alleviating Radiotherapy-Induced Fatigue in Breast Cancer Patients: A Randomized Phase II Trial
To assess the role of High-Dose Melatonin in Alleviating Radiotherapy-Induced Fatigue in Breast Cancer Patients. The primary end point is assessment of fatigue severity . Secondary end points Assessment of skin toxicity to evaluate melatonin's secondary radioprotective benefits
Read the detailed description
Radiotherapy triggers severe fatigue (affecting up to 90% of patients) by generating damaging reactive species (ROS/RNS) and disrupting systemic inflammatory/circadian balance.Melatonin acts as a potent antioxidant via a "scavenger cascade"-crossing membranes and neutralizing free radicals-while resynchronizing flattened diurnal cortisol/circadian rhythms.High doses of Doses of Melatonin during radiotherapy may improve sleep quality and lower clinical fatigue scores.
- Conditions
- Breast Cancer, Radiotherapy Induced Fatigue
- Being tested
- Melatonin, Placebo
- Keywords
- Breast cancer, Radiotherapy, Fatigue, Melatonin
- Medical subject headings
- Breast Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
for melatonin group (experimental) :Oral administration of 15 mg melatonin 30-60 min before bedtime on Day 1 of radiotherapy and continuing until 1 week post-completion of the final fraction (including the boost)
PlaceboDrug
Oral administration of an identical-appearing capsule containing microcrystalline cellulose 30-60 min before bedtime on Day 1 of radiotherapy and continuing until 1 week post-completion of the final fraction (including the boost)
| Study group | Role | What they receive |
|---|---|---|
| Melatonin Group | Experimental | Patients will be assigned to receive 15 mg of melatonin orally once daily, 30-60 minutes before bedtime, beginning on Day 1 of radiotherapy and continuing until 1 week after completion of the final radiotherapy fraction, including the boost. Receives: Drug: Melatonin |
| Placebo Group | Placebo comparator | Participants will receive an identical-appearing placebo capsule containing microcrystalline cellulose orally once daily, 30-60 minutes before bedtime, beginning on Day 1 of radiotherapy and continuing until 1 week after completion of the final radiotherapy fraction, including the boost. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Change in Fatigue Severity: Measured via the Piper Fatigue Scale (PFS)
Assessment of Change in Fatigue Severity: Fatigue severity will be assessed using the Revised Piper Fatigue Scale (PFS-R), a 22-item self-reported measure of cancer-related fatigue. The total score ranges from 0 to 10, with higher scores indicating greater fatigue severity and therefore a worse outcome.
Measured: During and 4 weeks post-radiotherapy
Secondary outcomes (1)
Assessment of skin toxicity using the RTOG grading scale to evaluate melatonin's secondary radioprotective benefits
Assessment of Skin Toxicity: Acute radiation-induced skin toxicity will be assessed using the Radiation Therapy Oncology Group (RTOG) acute radiation morbidity grading scale. Skin toxicity is graded from 0 to 4, where Grade 0 indicates no change from baseline and Grade 4 indicates the most severe toxicity, including ulceration, hemorrhage, or necrosis. Higher grades indicate greater skin toxicity and therefore a worse outcome.
Measured: During and three months post-radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start2 Oct 2024
- Primary completion9 Aug 2026
- Study completion20 Aug 2026
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 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Sohaib, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865988
- Sponsor's protocol ID
- MCI-MONCO6
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators of this study agreed to share IPD for free with any other investigators with the following conditions: * Sharing the data will be after publishing the primary results * Other studies using our data should submit our names as sub-investigators when publishing their results